glen apseloff, m - ohio clinical trials, inc.glen apseloff, m.d., f.c.p. ohio clinical trials, inc....
TRANSCRIPT
GLEN APSELOFF, M.D., F.C.P. Ohio Clinical Trials, Inc.
1380 Edgehill Road
Columbus, OH 43212
Office: (614) 754-1570
Fax: (614) 291-0817
Email: [email protected]
PROFESSIONAL MASSACHUSETTS GENERAL HOSPITAL, Boston, MA
EXPERIENCE Applications Programmer/Analyst, Laboratory of Computer Science.
Computerized three hospital laboratories at Massachusetts General Hospital.
1981 Developed software to optimize dosing schedules based on individual drug half-
to life and peak/trough levels. Conducted research in quality control in an acute care
1982 laboratory.
1986 MOUNT CARMEL MEDICAL CENTER, Columbus, OH
to Resident Physician, Obstetrics and Gynecology. Completed rotations in
1987 obstetrics/gynecology, medical intensive care, emergency medicine, psychiatry,
general surgery, and radiology.
1987 SOUTHERN OHIO EMERGENCY PHYSICIANS, Clearwater, OH
Emergency medicine. Solo in-house physician.
1987 MASTER/MAY FAMILY PRACTICE, Columbus, OH
to Provided family practice patient care to low-income patients in a high-volume,
1988 inner-city clinic.
1993 AMERICAN COLLEGE OF CLINICAL PHARMACOLOGY
Instructor for the review course for Board Examinations.
1988 OHIO STATE UNIVERSITY COLLEGE OF MEDICINE, DEPARTMENT
OF PHARMACOLOGY
Postprofessional Researcher. Assisted in conducting phase I clinical trials.
to Learned basic science techniques, including methods for the separation,
identification, and quantification of compounds – HPLC, GC, MS. Conducted
basic science research, and presented results at scientific meetings and in
1989 print.
1989 Research Scientist. Participated in all aspects of laboratory research, including
studies of pharmacokinetics and drug metabolism/disposition. Conceptualized,
designed, and wrote basic science/clinical protocols and grants, performed small-
to animal surgeries, analyzed biological samples, obtained use patents, and presented
data in print and in conferences. Organized and presented lectures for medical
2005 students and graduate students, and wrote questions for examinations.
1993 Adjunct Asst./Assoc. Professor. Instructed medical and graduate students,
including presenting lectures, teaching tutorials (problem-solving sessions),
to providing individual instruction, and writing examination questions. Served
as coadvisor for graduate students, and reviewed their progress toward a degree.
2005 Supervised a Master's track in Clinical Pharmacology.
2005 Research Professor/Scientist. Conduct research. Instruct medical students, graduate
students, and Fellows. Serve on departmental committees (e.g., admissions
to committee for graduate school). Oversee Master’s track and Fellowship program
in clinical pharmacology. Serve as course director for Design of Clinical Trials I
2014 and II. Write exam questions and conduct oral exams.
2014 to Adjunct Professor (retired). Instruct medical students and graduate students. Assist
present colleagues with research.
1991 Associate Director of Clinical Pharmacology. Assisted in all aspects of phase
I clinical trials: served as coinvestigator or principal investigator in clinical
to trials, wrote consent forms, and negotiated budgets. Marketed our facilities
to potential pharmaceutical sponsors. Interviewed prospective employees.
1997 Negotiated protocols with the FDA.
1997 Director of Clinical Pharmacology. Implement and direct phase I clinical
trials. Serve as principal investigator in industry-sponsored studies.
Negotiate contracts with pharmaceutical sponsors. Manage overall operations
to of the clinical program: coordinate simultaneous clinical trials; hire, train,
manage, and evaluate physician employees; oversee maintenance of facilities;
create and update standard operating procedures; design and update web site;
2012 market the program to potential pharmaceutical sponsors.
2012 OHIO CLINICAL TRIALS, INC.
President and Principal Investigator. Transitioned the clinical research program
to from Ohio State University to Ohio Clinical Trials, Inc. Added 3000+ sq. ft. and
increased capacity from 39 to 55 beds. Added services of medical/other monitoring,
present project management, data management, biostatistics, and medical writing.
EDUCATION MASSACHUSETTS INSTITUTE OF TECHNOLOGY, Cambridge, MA
Bachelor of Science Degree in Mathematics, May, 1981. GPA: 4.7/5.0.
OHIO STATE UNIVERSITY COLLEGE OF MEDICINE, Columbus, OH
Doctor of Medicine Degree, June, 1986. Honors in Preventive Medicine
and Behavioral Sciences. Letter of Commendation in Internal Medicine.
CREDENTIALS Board Certified in Clinical Pharmacology, 1992-present.
State of Ohio Medical License, 1987-present.
AND Certified in Advanced Cardiac Life Support (expir. Feb. 2017).
Smoking Cessation Educator (American Lung Association).
AWARDS Excellence in Teaching Award, Ohio State University College of Medicine, 2007.
Inducted into Kent City Schools Hall of Fame, 2012.
MEMBERSHIP Fellow of the American College of Clinical Pharmacology, 1992-present.
Editorial Board of The Journal of Clinical Pharmacology, 1993-present.
Editorial Board of American Journal of Therapeutics, 1994-present.
Section Editor (Therapeutic Reviews) 2008-present.
Editorial Board of Clinical Pharmacology & Therapeutics, 2001-present.
Member of the Am. Soc. for Pharmacol. & Exper. Therap., 1994-present.
Member of the Am. Soc. for Clin. Pharmacol. and Therap., 1997-present.
Member of the Am. Assoc. of Pharmaceutical Scientists, 1997-present.
Member of Drug Information Association, 1998-present.
PUBLICATIONS
1. Matkovic, V., Apseloff, G., Shepard, D.R., Gerber, N.: Use of gallium to treat Paget’s
disease of bone: a pilot study. Lancet, 335: 72-75, 1990.
2. Apseloff, G., Shepard, D.R., Chambers, M.A., Nawoot, S., Mays, D.C., Gerber, N.:
Inhibition and induction of theophylline metabolism by 8-methoxypsoralen: in vivo study in
rats and humans. Drug Metab. Dispos., 18: 298-303, 1990.
3. Matkovic, V., Apseloff, G., Shepard, D., Gerber, N.: Hazards of gallium for Paget’s disease
of bone. Invited reply to a letter. Lancet, 335: 1099, 1990.
4. Matkovic, V., Apseloff, G., Shepard, D., Jelic, T., Gerber, N.: Effects of gallium nitrate upon
bone turnover and serum lipid levels in postmenopausal women. Curr. Therap. Res., 50:
247-254, 1991.
5. Matkovic, V., Balboa, A., Clinchot, D., Whitacre, C., Zwilling, B., Brown, D., Weisbrode,
S.E., Apseloff, G., Gerber, N.: Gallium prevents adjuvant arthritis in rats and interferes with
macrophage/T-cell function in the immune response. Curr. Therap. Res., 50: 255-267, 1991.
6. Apseloff, G., Hilligoss, D.M., Gardner, M.J., Henry, E.B., Inskeep, P.B., Gerber, N., Lazar,
J.D.: Induction of fluconazole metabolism by rifampin: in vivo study in humans. J. Clin.
Pharmacol., 31: 358-361, 1991.
7. Apseloff, G., Hilliard, J.B., Gerber, N., Mays, D.C.: Inhibition and induction of drug
metabolism by psoralens: Alterations in duration of sleep induced by hexobarbital and in
clearance of caffeine and hexobarbital in mice. Xenobiotica, 21: 1461-1471, 1991.
8. Apseloff, G., Girten, B., Walker, M., Shepard, D. R., Matkovic, V., Stern, L.S., Gerber, N.:
Aminohydroxybutane bisphosphonate prevents bone loss in a rat model of simulated
weightlessness. Curr. Therap. Res., 50: 794-803, 1991.
9. Apseloff, G., Girten, B., Gerber, N., Shepard, D., Matkovic, V.: The effect of gallium nitrate
upon bone loss in a rat model of simulated microgravity. Aviat. Space Environ. Med., 63:
27-31, 1992.
10. Whitacre, C., Apseloff, G., Cox, K., Matkovic, V., Jewell, S., Gerber, N.: Suppression of
experimental autoimmune encephalomyelitis by gallium nitrate. J. Neuroimmunol., 39: 175-
182, 1992.
11. Apseloff, G., Wilner, K.D., von Deutsch, D.A., Henry, E.B., Tremaine, L.M., Gerber, N. and
Lazar, J.D.: Sertaline does not alter steady-state concentrations or renal clearance of lithium
in healthy volunteers. J. Clin. Pharmacol., 32: 643-646, 1992.
12. Apseloff, G., Whitacre, C., Gerber, N.: Long-term effects of gallium nitrate in patients with
Paget’s disease of bone. J. Bone Miner. Res., 7: 1240-1241, 1992.
PUBLICATIONS (cont)
13. Apseloff, G., Girten, B., Walker, M., Shepard, D.R., Krecic, M.E., Stern L.S., Gerber, N.:
Aminohydroxybutane bisphosphonate and clenbuterol prevent bone changes and retard
muscle atrophy respectively in tail-suspended rats. J. Pharmacol. Exp. Ther., 227: 1071-
1078, 1993.
14. Gerber, N., Apseloff, G. Death from a morphine infusion during a sickle cell crisis. J.
Pediatr., 123: 322-325, 1993.
15. Apseloff, G., Girten, B., Weisbrode, S.E., Walker, M., Stern, L.S., Krecic, M.E., Gerber, N.:
Effects of aminohydroxybutane bisphosphonate on bone growth when administered after
hind-limb bone loss in tail-suspended rats. J. Pharmacol. Exp. Ther., 267: 515-521, 1993.
16. Gerber, N., Apseloff, G.: Pain relief during sickle cell crisis. Invited reply to letter. J.
Pediatr., 124: 162-163, 1994.
17. Stern, L.S., Matkovic, V., Weisbrode, S.E., Apseloff, G., Shepard, D.R., Mays, D.C., Gerber,
N. The effects of gallium nitrate on osteopenia induced by ovariectomy and a low-calcium
diet in rats. Bone and Miner., 25: 59-69, 1994.
18. Apseloff, G., Ashton, H.M., Friedman, H., Gerber, N.: The importance of measuring cotinine
levels in clinical trials. Clin. Pharmacol. Ther., 56:460-462, 1994.
19. Apseloff, G., Wilner, K.D., Gerber, N.: Effect of tenidap sodium on the pharmacodynamics
and plasma protein binding of warfarin in healthy volunteers. Brit. J. Clin. Pharmacol., 39:
29S-33S, 1995.
20. Apseloff, G., Wilner, K.D., Von Deutsch, D.A., Gerber, N.: Tenidap sodium decreases renal
clearance and increases steady-state concentrations of lithium in healthy volunteers. Br. J.
Clin. Pharmacol., 39: 25S-28S, 1995.
21. Mays, D.C., Pawluk, L.J., Apseloff, G., Davis, W.B., She, Z., Sagone, A.L., Gerber, N.:
Metabolism of phenytoin and covalent binding of reactive intermediates in activated human
neutrophils. Biochem. Pharmacol., 50: 367-380, 1995.
22. Orosz, C.G., Wakely, E., Sergese, S.D., VanBuskirk, A.M., Ferguson, R.M., Mullet, D.,
Apseloff, G., Gerber, N.: Prevention of murine cardiac allograft rejection with gallium
nitrate: Comparison with anti-CD4 mAb. Transplantation, 61: 783-791, 1996.
23. Apseloff, G., Swayne, J., Gerber, N.: Medical histories may be unreliable in screening
volunteers for clinical trials. Clin. Pharmacol. Ther., 60: 353-356, 1996.
24. Apseloff, G., Foulds, G., LaBoy-Goral., L., Kraut, E., Vincent, J.: Severe neutropenia caused
by recommended prophylactic doses of rifabutin. Lancet, 348: 685, 1996.
PUBLICATIONS (cont)
25. Apseloff, G., Foulds,G., LaBoy-Goral, L., Vincent, J.: Severe neutropenia and prophylactic
doses of rifabutin. Invited reply to a letter. Lancet, 348: 1593, 1996.
26. Apseloff, G., Wilner, K.D., Gerber, N., Tremaine, L.M.: Effect of sertraline on protein
binding of warfarin. Clin. Pharmacokinet., 32: 37-42, 1997.
27. Apseloff, G. Swayne, J., Gerber, N.: Reliability of screening procedures in identifying
subjects suitable for enrollment in clinical pharmacology studies. Invited reply to a letter.
Clin. Pharmacol. Ther., 62: 113-114, 1997.
28. Apseloff, G., Hackshaw, K.V., Whitacre, C., Weisbrode, S.E., Gerber, N.: Gallium nitrate
suppresses lupus in MRL/lpr mice. Arch. Pharmacol., 356: 517-525, 1997.
29. Apseloff, G., Foulds, G., LaBoy-Goral, L., Willavize, S., Vincent J. Comparison of
azithromycin and clarithromycin in their interactions with rifabutin in healthy volunteers. J.
Clin. Pharmacol., 38: 830-835, 1998.
30. Liston, T.E., Conklyn, M.J., Houser, J., Wilner, K.D., Johnson, A., Apseloff, G., Whitacre,
C., Showell, H.J.: Pharmacokinetics and pharmacodynamics of the leukotriene B4 receptor
antagonist CP-105,696 in man following single oral administration. Br. J. Clin. Pharmacol.,
45: 115-121, 1998.
31. Foulds, G., LaBoy-Goral, L., Wei, G.C.G., Apseloff, G.: The effect of azithromycin on the
pharmacokinetics of indinavir. J. Clin. Pharmacol., 39: 842-846, 1999.
32. Krecic-Shepard, M.E., Shepard, D.R., Mullet, D., Apseloff, G., Weissbrode, S.E., Gerber, N.:
Gallium nitrate suppresses the production of nitric oxide and liver damage in a murine model
of LPS-induced septic shock. Life Sci., 65: 1359-1371, 1999.
33. Apseloff, G.: Therapeutic uses of gallium nitrate--past, present, and future. Am. J. Therap., 6:
327-339, 1999.
34. Apseloff, G., Mullet, D., Wilner, K.D., Anziano, R.J., Tensfeldt, T.G., Pelletier, S.M.,
Gerber, N.: The effects of ziprasidone on steady-state lithium levels and renal clearance of
lithium. Br. J. Clin. Pharmacol., 49(S1): 61-64, 2000.
35. Wilner, K.D., Demattos, S.B., Anziano, R.J., Apseloff, G., Gerber, N.: Ziprasidone and the
activity of cytochrome P450 2D6 in healthy extensive metabolizers. Br. J. Clin. Pharmacol.,
49(S1): 43-47, 2000.
36. Miceli, J.J., Wilner, K.D., Hansen, R.A., Johnson, A.C., Apseloff, G., Gerber, N.: Single-
and multiple-dose pharmacokinetics of ziprasidone under non-fasting conditions in healthy
male volunteers. Br. J. Clin. Pharmacol., 49(S1): 5-13, 2000.
PUBLICATIONS (cont)
37. Apseloff, G., Xiaohui, B., LaBoy-Goral, L., Friedman, H., Shah, A.: Practical considerations
regarding the influence of the menstrual cycle on leukocyte parameters in clinical trials. Am.
J. Therap., 7: 297-302, 2000.
38. Shah, A.K., LaBoy-Goral, L., Scott, N., Morse, T., Apseloff, G.: Pharmacokinetics and safety
of oral eletriptan during different phases of the menstrual cycle in healthy volunteers. J. Clin.
Pharmacol., 41: 1339-1344, 2001.
39. Gerber, N., Apseloff, G.: Fatality following an injection of Bicillin® into the tonsillar fossa
during an adenotonsillectomy. Otolaryngol. Head Neck Surg., 126: 321-2, 2002.
40. Tassava, R.A., Mendenhall, L., Apseloff, G., Gerber, N.: Gallium nitrate: effects on cartilage
during limb regeneration in the axolotl, Ambystoma mexicanum. J. Exp. Zool., 293: 384-94,
2002.
41. Apseloff, G.: HIV testing in early clinical trials – who should decide whether it is warranted?
J. Clin. Pharmacol., 42: 601-604, 2002.
42. Apseloff, G.: Severe neutropenia among healthy volunteers given rifabutin in clinical trials.
Clin. Pharmacol. Ther., 74: 591-592, 2003.
43. Stoner, G.D., Sardo, D., Apseloff, G., Mullet, D., Wargo, W., Pound, V., Singh, A., Sanders,
J., Aziz, R., Casto, B., Sun X.: Pharmacokinetics of anthocyanins and ellagic acid in healthy
volunteers fed freeze-dried black raspberries daily for 7 days. J. Clin. Pharmacol., 45: 1153-
1164, 2005.
44. Shah, A., DeGroot, T., Apseloff, G.: Pharmacokinetic evaluation and safety profile of a 15-
minute versus 30-second infusion of palonosetron in healthy subjects. J. Clin. Pharmacol.,
46: 1-7, 2006.
45. Tishler, C.L., Apseloff, G., Bartholomae, S., Reiss, N.S., Rhodes, A.R., Singh, A.: Are
normal healthy research volunteers psychologically healthy? A pilot investigation. Exp. Clin.
Psychopharmacol., 15: 539-545, 2007.
46. Cotreau, M.M., Chennathukuzhi, V.M., Harris, H.A., Han, L., Hatstat, E., Zakaria, M.,
Apseloff, G., Strahs, A.L., Crabtree, J.S., Winneker, R.C., Jelinsky, S.A.: A study of 17-
estradiol-regulated genes in the vagina of postmenopausal women with vaginal atrophy.
Maturitas, 58: 366-376, 2007.
47. Johnson, B.M., Adams, L.M., Zhang, K., Gainer, S.D., Kirby, L.C., Blum, R.A., Apseloff,
G., Morrison, R.A., Schutz, R.A., Lebowitz, P.F.: Ketoconazole and rifampin significantly
affect the pharmacokinetics, but not the safety or QTc interval, of casopitant, a neurokinin-1
receptor antagonist. J. Clin. Pharmacol., 50: 951-959, 2010.
PUBLICATIONS (cont)
48. Kitzmiller, J.P., Groen, D.K., Ardeleanu, M., Apseloff, G.: A novel minimally-invasive
method for eliciting incisional pain in healthy adults. J. Anaesth. Clin. Pharmacol. 26: 54-58,
2010.
49. Groen, D.K., Harris, S.C., Colucci, S., Apseloff, G.: Serum transaminase levels should be
measured immediately prior to dosing in early phase I clinical trials. J Clin Pharmacol. 51:
252-255, 2011.
50. Kapil, R.P., Cipriano, A., Friedman, K., Michels, G., Shet, M.S., Colucci, S.V., Apseloff, G.,
Kitzmiller, J., Harris, S.C.: Once-weekly transdermal buprenorphine application results in
sustained and consistent steady-state plasma levels. J. Pain Symptom Manag. 46: 65-75,
2013.
51. Apseloff, G., Onel, E., Patou, G.: Time to onset of analgesia following local infiltration of
liposome bupivacaine in healthy volunteers: a randomized, single-blind, sequential cohort,
crossover study, Int. J. Clin. Pharmacol. Therap. 51: 367-73, 2013.
52. Apseloff, G., Kitzmiller, J.P., Tishler, C.L.: Credibility and comprehension of healthy
volunteers in lengthy inpatient drug studies. Am. J. Therap. 20: 257-60, 2013.
53. Perrino, P.J., Colluci, S.V., Apseloff, G., Harris, S.C.: Pharmacokinetics, tolerability, and
safety of intranasal administration of reformulated OxyContin® tablets compared with
original OxyContin® tablets in healthy adults. Clin. Drug Invest. epub ahead of print, DOI
10.1007/s40261-013-0085-x, 2013.
54. Sardo, C.L., Kitzmiller, J.P., Apseloff, G., Harris, R.B., Roe, D.J., Stoner, G.D., Jacobs, E.T.:
An open-label, randomized crossover trial of lyophilized black raspberries on postprandial
inflammation in older, overweight males: a pilot study, Am. J. Therap. 2013 (in press).
55. Apseloff, G.: Reliability of professional volunteers recruited for clinical trials. J. Clin.
Pharmacol. 54: 616-18, 2014.
56. Nunez, D.J., Bush, M.A., Collins, D.A., McMullen, S.L., Gillmor, D., Apseloff, G.,
Atiee, G., Corsino, L., Morrow, L., Feldman, P.L. Gut hormone pharmacology of a novel
gpr119 agonist (gsk1292263), metformin, and sitagliptin in type 2 diabetes mellitus: results
from two randomized studies. PLOS ONE 9: e92494, 2014.
57. Kitzmiller, J.P., Phelps, M.A., Neidecker, M.V., Apseloff, G. Establishing a clinical
pharmacology fellowship program for physicians, pharmacists, and pharmacologists: a newly
accredited interdisciplinary training program at the Ohio State University. Advances Med.
Ed. Practice. 5: 1-6, 2014.
ABSTRACTS
1. Shepard, D., Apseloff, G., Balboa, A., Mays, D., Gerber, N., Matkovic, V.: The effect of
gallium nitrate on Paget’s disease of bone. Pharmacologist, 31: 161, 1989.
2. Matkovic, V., Apseloff, G., Mays, D., Balboa, A., Shepard, D., Gerber, N.: The effect of
gallium nitrate on bone resorption indices in humans and bone mineral density in
osteoporotic rat. Steenbock Symposium, 1989.
3. Matkovic, V., Apseloff, G., Mays, D., Balboa, A., Shepard, D., Gerber, N.: Plasma calcium
and alkaline phosphatase activity in postmenopausal women treated with gallium nitrate.
ASBMR/ICCRH First Joint Meeting, 1989.
4. Apseloff, G., Shepard, D., Chambers, M., Nawoot, S., Gerber, N., Mays, D.: Inhibition of
theophylline metabolism by 8-methoxypsoralen: in vivo study in humans. Europ. J. Clin.
Pharmacol., 36: 263, 1989.
5. Pawluk, L., Mays, D., She, Z., Davis, W., Apseloff, G., Gerber, N.: Metabolism of phenytoin
by activated human neutrophils. Europ. J. Clin. Pharmacol., 36: 251, 1989.
6. Apseloff, G., Chambers, M., Shepard, D., Nawoot, S., Mays, D., Gerber, N.: Inhibition and
induction of theophylline metabolism by 8-methoxypsoralen with resulting changes in its
renal excretion: in vivo study in the rat. FASEB J., 3: 2948, 1989.
7. Matkovic, V., Apseloff, G., Balboa, A., Shepard, D., Pawluk, L., Mays, D., Gerber, N.:
Gallium nitrate inhibits bone resorption in postmenopausal women. Pharmacologist, 31:
160, 1989.
8. Apseloff, G., Shepard, D.R., Balboa, A., Gerber, N., Mays, D.C., Weisbrode, S.E., Stern,
L.S., Matkovic, V.: The effect of gallium nitrate on osteopenia in rats and postmenopausal
women. Europ. J. Pharmacol., 183: 1760-1761, 1990.
9. Apseloff, G., Mays, D., Pacula, C., Gerber, N.: Isolation of 5-methoxypsoralen from Earl
Grey Tea. FASEB J., 4: A516, 1990.
10. Mays, D.C., Balboa, A., Pawluk, L.J., Nawoot, S., Apseloff, G., Gerber, N.: The rat is a
useful model to study azidothymidine pharmacokinetics. Clin. Pharm. Ther., 147: 157, 1990.
11. Wilner, K.D., Lazar, J.D., Apseloff, G., Gerber, N: The effects of sertraline on the
pharmacodynamics of warfarin in healthy volunteers. 5th World Congress of Biological
Sciences, 1991.
12. Wilner, K.D., Lazar, J.D., von Deutsch, D.A., Apseloff, G., Gerber, N.: The effects of
sertraline on steady-state lithium levels and renal clearance of lithium. 5th World Congress
of Biological Sciences, 1991.
ABSTRACTS (cont)
13. Matkovic, V., Gerber, N., Brown, D., Apseloff, G., Zwilling, B.S.: Differential effect of
gallium on MHC class II expression by murine macrophages. FASEB J., 5: A1206, 1991.
14. Stern, L.S., Matkovic, V., Gerber, N., Apseloff, G., Weisbrode, S.: Effects of gallium nitrate
on osteopenia in rats. Bone & Min. Res., 6(1): S216, 1991.
15. Apseloff, G., Girten, B., Weisbrode, S.E. Walker, M., Stern., L.S., Krecic, M.E.: Effects of
Aminohydroxybutane bisphosphonate on bone in tail-suspended rats, FASEB J., 7: A150,
1993.
16. Apseloff, G., Whitacre, C., Weisbrode, S.E., Krecic, M.E., Shepard, D.R., Hackshaw, K.,
Gerber, N.: Gallium suppresses lupus in MRL/lpr mice. ASCEPT, 1993.
17. Gerber, N., Apseloff, G.: Immunomodulatory effects of gallium nitrate. Future Trends in
Chemotherapy, Interdisciplinary World Congress on Antimicrobial and Anticancer Drugs,
Palexpo Geneva, Switzerland, 1994.
18. Apseloff, G., Hackshaw, K., Whitacre, C., Weisbrode, S.E., Gerber, N.: Gallium suppresses
lupus in MRL/lpr mice. FASEB J., 8: A645, 1994.
19. Koudriakova, T., Choe, S., Gerber, N., G. Apseloff: Dose-dependent elimination of 5-
methoxypsoralen: In vivo study in rats. FASEB J., 8: A99, 1994.
20. Krecic, M.E., Mullet, D., Shepard, D.R., Apseloff, G., Weisbrode, S.E., Zaveri, N., Gerber,
N.: Gallium nitrate attenuates lipopolysaccharide-induced hepatitis in Balb/c mice. ASCEPT,
1994.
21. Krecic, M.E., Shepard, D.R., Apseloff, G., Weisbrode, S.E., Gerber, N.: Gallium nitrate
attenuates lipopolysaccharide-induced hepatitis in Balb/c mice. FASEB J., 9: A944, 1995.
22. Collins, J., Choe, S., Spetie, D., Mullet, D., Koudriakova, T., Gerber, N., Apseloff, G.: Lack
of effect of cigarette smoking on the pharmacokinetics of rifabutin. FASEB J., 9: A688,
1995.
23. Koudriakova, T., Spetie, D., Utkin, I., Apseloff, G., Gerber, N.: Pharmacokinetics of
rifabutin in the rat. FASEB J., 9: A688, 1995.
24. Krecic, M.E., Mullet, D., Shepard, D.R., Apseloff, G., Weisbrode, S.E., Zaveri, N., Gerber,
N.: Gallium nitrate inhibits nitric oxide in vitro and attenuates lipopolysaccharide-induced
hepatitis in Balb/c mice in vivo. Proceedings of 6th INWIN, Geneva, Switzerland, 1995.
25. Weisbrode, S.E., Apseloff, G., Hackshaw, K.V., Whitacre, C., Gerber, N.: Gallium nitrate
reduces lesions in MRL/lpr mice. 13th European Congress on Veterinary Pathology,
Edinburgh, Scotland, 1995.
ABSTRACTS (cont)
26. Weisbrode, S.E., Apseloff, G., Hackshaw, K.V., Whitacre, C., Gerber, N.: Gallium nitrate
ameliorates spontaneous lesions in MRL/lpr mice but induces osteosclerosis. 46th Annual
Meeting, Bone & Joint Specialty Groups, Atlanta, GA, 1995.
27. Apseloff, G., LeRoy, B., Weisbrode, S.E., Collins, J., Gerber, N., Mullet, D.: Gallium nitrate
ameliorates asthma in B6D2F1/J mice. FASEB J., 10: A441, 1996.
28. Teng, R., Apseloff, G., Vincent, J., Pelletier, S.M., Willavize, S.A., Friedman, H.L.: Effect of
trovafloxacin (CP-99,219) on the pharmacokinetics and pharmacodynamics of warfarin in
healthy male subjects. 36th ICAAC, 1996.
29. Vincent, J., Foulds, G., Apseloff, G., Laboy-Goral, L., Gerber, N.: Interaction of rifabutin
(RIF) with the macrolides azithromycin (AZM) and clarithromycin (CLA). 36th ICAAC,
1996.
30. Foulds, G., LaBoy-Goral, L., Wei, G., Apseloff, G.: The effect of azithromycin (AZM) on the
pharmacokinetics of indinavir (IND). Fourth International Conference on the Macrolides,
Azalides, Streptogramins & Ketolides. Barcelona, Spain. Abstract #5.04, p. 53, 1998.
31. Vincent, J., Gardner, M.J., Apseloff, G., Baris, B., Willavize, S., Friedman, H.L.: Cimetidine
inhibits renal elimination of dofetilide without altering QTc activity on multiple dosing in
healthy subjects. Clin. Pharmacol. Therap., 63: 210, 1998.
32. Vincent, J., Agin, M., LaBoy-Goral, L., Hunt, T., Carlson, J., Apseloff, G., Kuye, O.: The
effect of dosing with food and bedtime dosing on the incidence of dizziness with
trovafloxacin in young, healthy, female subjects. 38th ICAAC, 1998.
33. Shah, A.K., Friedman, D.L., Morse, T.M., LaBoy-Goral, L., Hinkel, C.A., Silber, M.,
Apseloff, G., Friedman, H.L.: Evaluation of methods for rapid screening of CYP2D6 status
using dextromethorphan as a probe in normal, healthy subjects. aaps PharmSci Suppl., 1(1):
S-32, 1998.
34. Apseloff, G., Vashi, V., Kuye, O.: Lack of a pharmacokinetic interaction between amlodipine
and atorvastatin at steady-state. aaps PharmSci Suppl., 1(1): S-623, 1998.
35. Sardo, C., Sun, X, Apseloff, G., Mullet, D., Wargo, W., Pound, V., Singh, A., Sanders, J.,
Aziz, R., Casto, B., Stoner, G.: Pharmacokinetics of anthocyanins and ellagic acid in healthy
subjects consuming black raspberries. Cancer Epidemiology Biomarkers and Prevention,
13(11): Part 2, 1882S, 2004.
36. Jones, T., Apseloff, G., Carter, E.: Comparative pharmacokinetics of topical tacrolimus
cream 0.03% with cream 0.01% and ointment 0.03% in adults and with ointment 0.03% in
pediatric patients with atopic dermatitis. J. Am. Acad. Derm. 52(3): 68, 2005.
ABSTRACTS (cont)
37. Singh, A., Apseloff, G., Colucci, R., Harris S.C., Vashi, V.: A crossover study with single &
divided-dose oral naloxone (NX), oral pentazocine/NX, & intravenous NX in healthy
subjects. Clin. Pharmacol. Therap., 77(2): P85, 2005.
38. Apseloff, G., Singh, A., Vause E., Richards P.: Determination of the optimal configuration of
ALGRX 3268 for induction of local analgesia prior to venipuncture in the antecubital fossa.
J. Pain, 6(3): S50, 2005.
39. Apseloff, G., Vause E., Singh, A., Sykes, D.: Treatment with ALGRX 3268 does not result in
detectable lidocaine levels in healthy adults. J. Pain, 6(3): S49, 2005.
40. Apseloff, G., Gallagher, S., Shah, A.: Pharmacokinetics (PK) and safety evaluation of
palonosetron (PALO) administered as a 15-minute infusion versus a 30-second infusion in
healthy subjects. Support. Care Cancer, 13: 412-413, 2005.
41. Strout, V., Casey, L., Nardone, L., Curtis, K., Adaelu, J., D’Alia, G., Lazar, J., Singh, A.,
Apseloff, G.: ETI-204, a monoclonal antibody with high affinity against protective antigen
produced by anthrax, is well tolerated and safe when administered alone or with
ciprofloxacin in healthy volunteers. 46th ICAAC Abstract Book, p. 41, 2006.
42. Kitzmiller, J., Groen, D., Apseloff, G.: An analysis of subjects in clinical trials who, after
dosing, report predose adverse events and abnormalities in their past medical histories. Clin.
Pharmacol. Therap., 85: S19, 2009.
43. Singh, A., Apseloff, G., Groen, D., Tishler, C., Bartholomae, S.: Characteristics and attitudes
of participants in a phase I clinical trial. Clin. Pharmacol. Therap., 85: S79, 2009.
44. Groen, D.K., Harris, S.C., Apseloff, G., Colucci, S.: Benefits of measuring liver function
tests immediately prior to dosing in early phase I clinical trials. Clin. Pharmacol. Therap., 85:
S19, 2009.
45. Groen, D.K., Harris, S.C., Singh, A., Apseloff, G.: Implications of nonsustained ventricular
tachycardia (NSVT) in healthy subjects in clinical trials. Clin. Pharmacol. Therap., 89: S72,
2011.
46. Kitzmiller, J.P., Groen, D.K., Singh, A., Savage, L., Cipriano, A., Friedman, K., Harris,
S.C., Apseloff, G. Multiple-application pharmacokinetics and adhesion analyses of
a buprenorphine transdermal system. J. Pain 2011; 12(4): P58.
47. Kitzmiller, J.P., Cirpili, E.M., Apseloff, G. A comparison of three methods for eliciting
thermal pain in healthy males. J. Pain 2012; 13(4S), S24.
48. Nunez, D., Bush, B., Collins, D., McMullen, S., Apseloff, G., Atiee, G., Carsina, L., Morrow,
L., Feldman, P. Novel effects on lipids of GSK1292263, a GPR119 agonist, in type 2
diabetics. Diabetes 2012; 61 (suppl 1):A279-280.
ABSTRACTS (cont)
49. Colucci, S., Harris, S., Perrino, P.J., Apseloff, G. Safety, tolerability, and pharmacokinetics
of crushed intranasal oxycodone tamper-resistant tablets and OxyContin® in healthy adults.
Poster presented at: College on Problems of Drug Dependence (CPDD) 74th Annual
Meeting; June 9-14, 2012; Palm Springs, CA.
OTHER PUBLICATIONS
Apseloff, G. Atlantic Puffin, Machias Seal Island. Filler photograph, N. Engl. J. Med. 365(23):
2219, 2011.
News & Views, Dedicated Member, Clin. Pharmacol. Therap., 90:759-60, 2011.
Apseloff, G. Grizzly Bear, Katmai National Park, Alaska. Filler photograph, N. Engl. J. Med.
366(16): 1543, 2012.
Apseloff, G. Brown Pelicans, Key Largo, Florida. Filler photograph, N. Engl. J. Med. 367(21):
2062, 2012.
Apseloff, G. Scarlet Macaw, Osa Peninsula, Costa Rica. Filler photograph, N. Engl. J. Med.
368(17): 1651, 2013.
Apseloff, G. Backyard Birds: Looking Through the Glass, Ohio Distinctive Publishing, 2013.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS
(Performed initially as an investigator at the Ohio State University [through December 2011] and
then at Ohio Clinical Trials, Inc.)
1. Phase I Study to Determine the Difference Between Urine Concentrations of CP-73-850 at
Steady State and the Urine Solubility of CP-73,850 in Healthy Volunteers (078-007-501),
1988. Pfizer, Inc. Co-Investigator.
2. Disopyramide Bioavailability Pilot Study Protocol Kinaform, 1988. Chartwell Technologies
Inc. Co-Investigator.
3. Pilot Study to Assess the Reproducibility of Steady State Serum Lithium Concentrations and
Renal Clearance of Lithium in Healthy Volunteers (050-015-501), 1988. Pfizer, Inc. Co-
Investigator.
4. Phase I Study of the Effect of Concomitant Antacid Administration on the Absorption of
Azithromycin (066-015-501), 1988. Pfizer, Inc. Co-Investigator.
5. A Multiple Dose, Double-Blind, Placebo-Controlled Study of the Safety, Toleration and
Pharmacokinetics of CP-72,467 in Healthy Male Volunteers (118-001-501), 1988. Pfizer,
Inc. Co-Investigator.
6. Phase I Study to Assess the Potential of Amlodipine to Alter the Pharmacodynamics of
Warfarin (053-011-501), 1988. Pfizer, Inc. Co-Investigator.
7. Phase I Study to Assess the Potential of Sertraline to Alter Steady State Serum Lithium
Levels and Renal Clearance of Lithium in Healthy Volunteers (050-017-501), 1988. Pfizer,
Inc. Co-Investigator.
8. Phase I Study of the Effect of Concomitant Cimetidine Administration on the Absorption of
Azithromycin (066-016-501), 1988. Pfizer, Inc. Co-Investigator.
9. Evaluation of the Safety, Clinical Activity, Toleration and Pharmacokinetics of CP-80,794. A
Single Escalating Dose Study in Normotensive Healthy Volunteers (120-001-501), 1988.
Pfizer, Inc. Co-Investigator.
10. A Phase I Study in Normal Male Volunteers to Assess the Safety, Toleration and
Pharmacokinetics of CP-72,133-2 (110-001-501), 1988-1989. Pfizer, Inc. Co-Investigator.
11. An Ultrasound Study of Ovarian Cyst Activity Comparing CTR-04 and CTR-05 Versus a
Concurrent Untreated Control (013-010), 1989 - 1990. Organon. Principal Investigator.
12. Phase I Study of the Safety, Toleration, and Bioavailability of Two Topical Piroxicam
Formulations in Healthy Volunteers (020-001-501), 1989. Pfizer, Inc. Co-Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
13. CGS-13492A Single-Oral-Dose Safety Study in Volunteers, Protocol 01, Version 2, 1989.
Ciba-Geigy. Co-Investigator.
14. Phase I Study of the Effect of Concomitant Rifampin Therapy on the Disposition of
Fluconazole (056-008-501), 1989. Pfizer, Inc. Co-Investigator.
15. Test of the Absorption of Adria Magnesium Lactate Tablets (114002-000), 1989. Adria
Laboratories. Co-Investigator.
16. Phase I, Multiple Dose, Double-Blind, Placebo-Controlled Study Evaluating the Safety and
Pharmacokinetics of CP-80,794 in Normotensive Male Volunteers (120-003-501), 1989.
Pfizer, Inc. Co-Investigator.
17. Phase I Study to Assess the Safety, Toleration and Bioavailability of Topically Applied CP-
70,490-09 (124-002-501), 1989. Pfizer, Inc. Co-Investigator.
18. A Bioavailability Study of Three Formulations of CP-72,133 (110-003-501), 1989. Pfizer,
Inc. Co-Investigator.
19. Phase I Study to Assess the Potential of Tenidap Sodium to Alter Steady State Serum
Lithium Levels and Renal Clearance of Lithium in Healthy Volunteers (064-017-501),
1989. Pfizer, Inc. Co-Investigator.
20. Phase I Study to Assess the Potential of Tenidap Sodium to Alter the Pharmacodynamics and
Plasma Protein Binding of Warfarin in Healthy Volunteers (064-018-501), 1989. Pfizer, Inc.
Co-Investigator.
21. Single Dose Pharmacokinetic and Bioavailability Study of Toremifene in Postmenopausal
Healthy Volunteers (092016-000), 1989 - 1991. Adria Laboratories. Co-Investigator.
22. Phase I Multiple Dose, Double-Blind, Placebo-Controlled, Study Evaluating the Safety and
Pharmacokinetics of Oral CP-72,133 in Normal Male Volunteers (110-002-501), 1989.
Pfizer, Inc. Co-Investigator.
23. Single Oral Dose Safety Study of CGS-13429A in Volunteers (amended), 1989. Ciba-Geigy.
Co-Investigator.
24. Phase I Multiple Dose, Double-Blind, Placebo-Controlled Study Evaluating the Safety and
Pharmacokinetics of Topically Applied CP-70,490-09 in Normal Male Volunteers (120-004-
501), 1989. Pfizer, Inc. Co-Investigator.
25. Relative Bioavailability and Dose Proportionality of CGS-13429A Following Single Doses
of 4.0 mg Oral Buffered Solution, Two 2.0 mg Tablets and 4.0 mg Duodenal Infusion in the
Fasted State and Two 20.0 mg Tablets Non-Fasted in Healthy Volunteers (Protocol 02),
1989. Ciba-Geigy. Co-Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
26. Phase I Study to Assess the Potential of Sertraline to Alter the Pharmacodynamics and
Plasma Protein Binding of Warfarin in Healthy Male Volunteers (050-018-501), 1989.
Pfizer, Inc. Co-Investigator.
27. Open Label Crossover Study of the Uricosuric Activity of Single Doses of Tenidap Sodium
(CP-66,248-2) Compared to Probenecid (064-025-501), 1989. Pfizer, Inc. Co-Investigator.
28. Phase I Multiple Dose, Double-Blind, Placebo-Controlled, Study Evaluating the Safety and
Pharmacokinetics of Oral CP-72,133 in Normal Male Volunteers (110-002-501).
Rechallenge. 1989. Pfizer, Inc. Co-Investigator.
29. Phase I Study of the Effect of Concomitant Antacid Administration on the Absorption of
Amlodipine (053-012-501), 1990. Pfizer, Inc. Co-Investigator.
30. Single Dose Study of CP-86,325-2 in Normal Healthy Male Volunteers (127-001-501), 1990.
Pfizer, Inc. Co-Investigator.
31. Multiple Oral Dose Safety Study of CGS-15873A in Healthy Normal Male Volunteers (06),
1990. Ciba-Geigy. Co-Investigator.
32. Phase I Double-Blind, Placebo-Controlled Evaluation of the Safety, Toleration, and
Pharmacokinetics of CP-88,059-1 Following Escalating Single Oral Doses in Healthy Male
Volunteers (128-001-501), 1990. Pfizer, Inc. (Section 1). Co-Investigator.
33. Phase I Multiple Dose, Double-Blind, Placebo-Controlled, Study Evaluating the Safety and
Pharmacokinetics of Oral CP-86,325-2 in Normal Male Volunteers (127-002-501), 1990.
Pfizer, Inc. Co-Investigator.
34. Phase I Multiple Dose, Double-Blind, Placebo-Controlled Study Evaluating the Safety and
Pharmacokinetics of Oral CP-88,059-1 in Normal Male Volunteers (128-002-501), 1990.
Pfizer, Inc. Co-Investigator.
35. Multiple Oral Dose Safety Study of CGS-18102A in Healthy Normal Male Volunteers (02),
1990. Ciba-Geigy. Co-Investigator.
36. A Continued Assessment of the Safety, Tolerance, and Pharmacokinetics of Single
Intravenous Doses of ADR-851 Compared to Placebo in Normal Healthy Male Volunteers
(117003-000), 1990. Adria Laboratories. Principal Investigator.
37. Double-Blind, Multiple Dose, Dose Escalating Safety Study of Intravenous RG 12915 in
Normal Volunteers, 1990. Rorer Central Research. Principal Investigator.
38. Phase I Multiple Dose, Double-Blind, Placebo-Controlled Study Evaluating the Safety and
Pharmacokinetics of Oral CP-88,059-1 Titrated from 20 Mg BID to Either 60 Mg BID or 80
Mg BID in Normal Male Volunteers (128-005-501), 1991. Pfizer, Inc. Co-Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
39. Phase I Double-Blind Evaluation of the Biological Effects and Safety of Multiple Doses of
CP-74,639 in Normal Subjects (090-003-501), 1991. Pfizer, Inc. Co-Investigator.
40. Phase I Crossover Study to Compare the Uricosuric Activity of a Single Dose of Sertraline
with that of Probenecid (050-023-501), 1991. Pfizer, Inc. Co-Investigator.
41. Phase I Double-Blind Evaluation, Placebo-Controlled Evaluation of the Safety, Toleration
and Pharmacokinetics of CP-108,671 Following Escalating Single Oral Doses in
Normotensive Male Volunteers (147-001-501), 1991. Pfizer, Inc. Co-Investigator.
42. Phase I Study to Determine the Levels of Tenidap Excreted in Breast Milk Compared with
the Plasma Levels of Tenidap in Normal Healthy Nursing Women (064-020-501), 1992.
Pfizer, Inc. Co-Investigator.
43. Phase I Multiple Dose, Double-Blind, Placebo-Controlled, Study Evaluating the Safety and
Pharmacokinetics of Oral CP-86,325-2 at Doses of 50 to 200 mg/day in Normal Male
Volunteers (127-003-501), 1992. Pfizer, Inc. Principal Investigator.
44. Phase I Study to Examine the Metabolism and Excretion of 14C-Tenidap in Patients with
Biliary T-Tube Drainage (064-047-504), 1992. Pfizer, Inc. Principal Investigator.
45. Phase I Multiple Dose, Single-Blind Study to Assess the Effect of Tenidap on Platelet
Aggregation and Serotonin Release in Normal, Healthy Male Volunteers Ex Vivo (064-050-
504), 1992. Pfizer, Inc. Principal Investigator.
46. Phase I Single Dose, Double-Blind, Placebo-Controlled, Study Comparing the Safety and
Pharmacokinetics of Oral CP-86,325 to its Metabolite, CP-95,637 in Normal Male
Volunteers (127-004-501), 1992. Pfizer, Inc. Principal Investigator.
47. Double-Blind Evaluation of the Safety and Pharmacokinetics of Single Ascending
Intravenous Doses of FK-037 (RWJ 45914-144) in Normal Subjects (M92-001), 1992. R.W.
Johnson. Principal Investigator.
48. Phase I Study of the Pharmacokinetics and Tolerability of Escalating Single Oral Doses of
SC-49483 in HIV-1(+) Volunteers with >300 CD4+ Cells/mm3 (NQ3-92-02-101), 1992.
G.D. Searle. Principal Investigator.
49. Phase I Double-Blind, Placebo-Controlled Evaluation of the Safety, Toleration and
Pharmacokinetics of CP-105,696 Following Escalating Single Oral Doses in Normal Male
Volunteers (158-001-501), 1992. Pfizer, Inc. Principal Investigator.
50. Phase I Multiple Dose, Double-Blind, Placebo-Controlled Study Evaluating the Safety and
Pharmacokinetics of Oral CP-88,059-1 Under Non-Fasting Conditions in Normal Male
Volunteers (128-013-501), 1992. Pfizer, Inc. Principal Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
51. A Pilot Study to Assess the Oral Absorption Profile of Azithromycin in Ileostomy Patients
(066-049-501), 1992. Pfizer, Inc. Principal Investigator.
52. A Double-Blind, Randomized, Placebo Controlled, Dose Escalating, Crossover Study to
Evaluate Safety, Tolerability and Delivery Rates of Sandostatin® via Iontophoresis in
Healthy Male Volunteers (Z101), 1993. Sandoz Pharmaceuticals Corporation. Principal
Investigator.
53. Phase I Multiple Dose Double-Blind, Placebo-Controlled Evaluation of the Safety,
Toleration and Pharmacokinetics of CP-105,696 in Normal Male Volunteers (158-002-501).
1993. Pfizer, Inc. Principal Investigator.
54. An Observer-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Cimetidine on
the Pharmacokinetics and Pharmacodynamics of Dofetilide After Multiple Dosing (115-004-
501), 1993. Pfizer, Inc. Principal Investigator.
55. An Open-Label, Single Dose, Crossover Study in Adult, Male Volunteers to Evaluate the
Effect of Food on Bioavailability of SDZWAG994 (P103), 1993. Sandoz Pharmaceuticals
Corporation. Principal Investigator.
56. Phase I Double Blind, Placebo Controlled, Study of the Safety, Toleration and
Pharmacokinetics of CP-114,271 When Administered as Escalating Single Doses to
Moderately Obese Volunteers (151-001-501), 1993. Pfizer, Inc. Principal Investigator.
57. A Two-Phase, Double-Blind, Placebo Controlled, Study in Adult Male Volunteers to
Evaluate the Interaction of Digoxin and SDZ WAG 994 (P109), 1993. Sandoz
Pharmaceuticals Incorporation. Principal Investigator.
58. Phase I Multiple Dose, Double-Blind, Placebo-Controlled Study Evaluating the Safety and
Pharmacokinetics of Oral CP-88,059-1 Under Non-Fasting Conditions in Normal Male
Volunteers (128-013-501), 1993. Pfizer, Inc. Principal Investigator.
59. A Multiple-Dose Evaluation of the Contribution of the Antihistamine Component of Regular
Dristan® Nasal Spray to the Symptomatic Relief of Nasal Congestion Associated with Upper
Respiratory Tract Infections (WM-600), 1993-1995. Whitehall/Kendle Research Associates.
Co-Investigator.
60. Phase I, Double Blind, Placebo Controlled, Study of the Safety, Toleration, Pharmacokinetics
and Pharmacodynamics of CP-114,271 When Administered as Escalating Multiple Doses to
Moderately Obese Volunteers (151-002-501), 1993. Pfizer, Inc. Principal Investigator.
61. Phase I Open Pilot Study to Compare the Pharmacokinetics of a Single 80 mg Oral Dose of
CP-88,059-1 Administered as Four 20 mg Capsules and One 80 mg Capsule to Normal,
Healthy Male Volunteers (128-019-501), 1993. Pfizer, Inc. Principal Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
62. An Open Label Study of OG 37-325 in Stable Renal Transplant Patients to Evaluate the
effect of Concomitant Administration of a Single Dose of Erythromycin Ethylsuccinate
(EES) on the Pharmacokinetic Profile of OG 37-325 (P335), 1994. Sandoz Pharmaceuticals
Incorporation. Principal Investigator.
63. Experiments Involving Endotoxin-Mediated Hepatitis and Endotoxic Shock in Mice and
other Species, 1994. Ben Venue Laboratories. Co-Investigator.
64. An Open-Label Study in Healthy Volunteers to Evaluate the Absorption of SDZ WAG 994
from the Small and Large Intestine (P121), 1994. Sandoz Pharmaceuticals Incorporation.
Principal Investigator.
65. Phase I Double-Blind, Placebo Controlled, Evaluation of Safety, Toleration, and
Pharmacokinetics of CJ-11,802 Following Escalating Single Oral Doses in Healthy Male
Volunteers (177-001-501), 1994. Pfizer, Inc. Principal Investigator.
66. Phase I Comparative Study of the Clinical Pharmacology of Azithromycin High Dosage
Strength Tablets After Fed and Fasted States in HIV-Infected Male Subjects (066-061-501),
1994. Pfizer, Inc. Co-Investigator.
67. Phase I Open Study to Assess the Potential of Ziprasidone to Alter the Renal Clearance of
Lithium and Steady-State Serum Lithium Levels in Normal, Healthy Male Volunteers (128-
025-501), 1994. Pfizer, Inc. Co-Investigator.
68. Phase I, Double-Blind, Placebo-Controlled, Crossover Evaluation of the Effects of CJ-11,974
on the Hypoxic Ventilatory Drive and the Perception of Dyspnea in Healthy Male Subjects
(167-005-4005), 1994. Pfizer, Inc. Co-Investigator.
69. Open Study Performed in a Parallel Group Design to Investigate the Effect of Age on the
Pharmacokinetics of Monatepil in 15 Elderly and 15 Young Volunteers Matched for Body
Surface (DA285), 1994-1995. LAB. Co-Investigator.
70. Phase I Double-Blind, Parallel, Placebo Controlled Pilot Study to Assess the Safety,
Toleration and Pharmacokinetics of Oral Sertraline Administered as a Single Dose and Over
a Defined Period of Time to Normal, Healthy Male Volunteers (050-031-501), 1995. Pfizer,
Inc. Principal Investigator.
71. Phase II Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
of the Efficacy and Safety of Six Weeks Treatment with Oral CJ-11,974 in Adults with Mild
to Moderate Asthma (167-102-4005), 1995. Pfizer, Inc. Co-Investigator.
72. Phase I, Open Study to Assess the Potential of Zopolrestat to Alter the Pharmacodynamics
and Plasma Protein Binding of Warfarin in Normal, Healthy Male Volunteers (078-014-501),
1994. Pfizer, Inc. Co-Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
73. A Placebo-Controlled Study to Compare the Gastrointestinal Effects of Different
Formulations of Azithromycin When Given as a Single Oral Dose to Parallel Groups of
Healthy Volunteers (066-072), 1995. Pfizer, Inc. Co-Investigator.
74. Phase I Double-Blind, Placebo-Controlled, Study of the Clinical Pharmacology of Multiple
Doses of CP-143,867 in Healthy Male Subjects (175-006), 1995. Pfizer, Inc. Co-
Investigator.
75. Phase I Open Pilot Study to Compare the Pharmacokinetics of Ziprasidone Administered as 2
X 20 mg Research Capsules and as a 40 mg Proposed Commercial Suspension in Normal
Healthy Subjects (128-034-501), 1995. Pfizer, Inc. Principal Investigator.
76. Phase I Study to Evaluate the Pharmacokinetic Interaction Between Rifabutin and the
Macrolides Azithromycin and Clarithromycin in Healthy Subjects (066-074-501), 1995.
Pfizer, Inc. Principal Investigator.
77. The Effect of Trovafloxacin on the Pharmacodynamics of Warfarin in Healthy Male Subjects
(154-034-501), 1995. Pfizer, Inc. Principal Investigator.
78. Phase I Pilot Open Study to Compare the Pharmacokinetics of a Single 300 Mg Oral Dose of
CP-195,543 Administered as a Capsule Under Fasting and Fed Conditions and as a
Suspension Under Fasting Conditions in Healthy Volunteers (207-003-501), 1995. Pfizer,
Inc. Principal Investigator.
79. Phase I Open Study to Evaluate Renal Function in Normal, Healthy Male Volunteers (064-
408-501), 1995. Pfizer, Inc. Principal Investigator.
80. Phase I Double-Blind, Placebo-Controlled Evaluation of the Safety, Toleration, and
Pharmacokinetics of CJ-12,255 Following Escalating Single Oral Doses in Healthy Male
Subjects (219-001), 1995. Pfizer, Inc. Principal Investigator.
81. Phase I Double-Blind, Parallel, Placebo-Controlled Pilot Study to Assess the Safety,
Toleration and Pharmacokinetics of Oral Sertraline Administered as a Single Dose and Over
a Defined Period of Time to Normal, Healthy Male or Female Volunteers, Part II (050-032),
1995. Pfizer, Inc. Principal Investigator.
82. Evaluation of Methods for Rapid Screening of Polymorphic Metabolism Status Using
Dextromethorphan as a Probe in Normal, Healthy Subjects (161-402-9501), 1996. Pfizer,
Inc. Principal Investigator.
83. Phase I Open Study to Assess the Potential of a CYP 2D6 Interaction of Ziprasidone Using
Dextromethorphan in Normal, Healthy Subjects (128-048-501), 1996. Pfizer, Inc. Co-
Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
84. Phase I Open Crossover Study of the Relative Bioavailability of CJ-12,255 Administered as a
Solution in the Fasted and Postprandial States (219-002-9501), 1996. Pfizer, Inc. Principal
Investigator.
85. Phase I Study to Determine the Excretion into Breast Milk and Pharmacokinetics After
Single Oral Dose Administration of Eletriptan in Normal, Healthy Nursing Women (160-
003-9501), 1996. Pfizer, Inc. Principal Investigator.
86. A Study to Assess the Effect of a Single 1200 mg Dose of Azithromycin on the
Pharmacokinetics of Indinavir (066-085-9501), 1996. Pfizer, Inc. Principal Investigator.
87. Phase I Pilot Open Study to Compare the Pharmacokinetics of a Single 100 mg Oral Dose of
CP-88,144 Administered as a Capsule Under Fasting and Fed Conditions to Healthy
Volunteers (225-003-9501), 1996. Pfizer, Inc. Principal Investigator.
88. Phase I Study to Determine the Influence of Different Phases of the Menstrual Cycle on the
Pharmacokinetics After Single Oral Dose Administration of Eletriptan in Normal, Healthy
Female Subjects (160-004-9501), 1997. Pfizer, Inc. Principal Investigator.
89. The Effect of Amlodipine on the Pharmacokinetics of Atorvastatin in Healthy Male Subjects
(053-019-80B), 1997. Pfizer, Inc. Principal Investigator.
90. Phase I Open Study to Compare the Bioavailability of Pseudoephedrine Administered as an
asymmetric membrane technology (AMT) tablet versus Efidac/24® After Single Dose
Administration to Normal Healthy Subjects (S/B 97Ck16-0705/97-N-001 and 143-002-
9501), 1997. Pfizer, Inc. Principal Investigator.
91. Phase I Pilot Open Study to Compare the Pharmacokinetics of a Single 10 mg Oral Dose of
CP-361,428 Administered as a Tablet Under Fasting and Fed Conditions to Healthy
Volunteers (245-003-501), 1997. Pfizer, Inc. Principal Investigator.
92. Phase I Double-Blind, Placebo-Controlled Evaluation of the Safety, Toleration, and
Pharmacokinetics of CP-409,092 Following Escalating Single Oral Doses in Healthy Male
Subjects (270-001-9501), 1997. Pfizer, Inc. Principal Investigator.
93. Evaluation of the Efficacy of Gallium Nitrate in the Treatment of Sarcoidosis, 1997. Ben
Venue Laboratories. Principal Investigator.
94. An Open-label, Multiple Dose, Two-way Crossover Comparison of Efidac/24® versus
Sudafed® in Healthy Subjects (143-401-9501), 1997. Pfizer, Inc. Principal Investigator.
95. Escalating, Single Dose, Placebo-Controlled, Double-Blind, Randomized, Safety, Toleration,
Pharmacokinetic and Pharmacodynamic Study of CP-368,296 Administered orally to
Normal, Healthy Subjects and Non-Insulin Dependent Diabetic Subjects (263-001-9501).
1997. Pfizer, Inc. Principal Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
96. Phase I Study to Determine the Influence of Different Phases of the Menstrual Cycle on
Leukocyte Counts and Leukocyte Profiles, 1997. Pfizer, Inc. Principal Investigator.
97. The Effect of Food and Time of Drug Administration in the Safety and Toleration of
Trovafloxacin in Young Female Subjects (154-055-9501), 1997. Pfizer, Inc. Principal
Investigator.
98. Phase I Study to Examine the Serum Concentrations of CP-66,458 Following Administration
of Azithromycin as Capsules and Tablets in the Fasted and Fed States (066-093-9501), 1997.
Pfizer, Inc. Principal Investigator.
99. Phase I Double-Blind, Placebo-Controlled Evaluation of the Safety, Toleration,
Pharmacokinetics of CJ-11,974 in Healthy, Elderly Volunteers (167-007-9501), 1997.
Pfizer, Inc. Principal Investigator.
100. Phase I Double-Blind, Placebo-Controlled Study of the Clinical Pharmacology of CP-
409,092 Following Multiple Dosing in Healthy Male Subjects (270-003-9501), 1997-8.
Pfizer, Inc. Principal Investigator.
101. An Open, 3-Way Single Dose, Crossover Study to Determine the Pharmacokinetics of CP-
409,092 under Fasting and Fed Conditions in Healthy Male Subjects (270-002-9501), 1998.
Pfizer, Inc. Principal Investigator.
102. Phase I Open Pilot Evaluation of the Effect of Food on the Bioavailability of a Controlled
Release CP-409,092 Dosage Form Relative to a Fasting Solution Dose in Healthy Male
Subjects (270-006-9501), 1998. Pfizer, Inc. Principal Investigator.
103. Phase I Open Pilot Evaluation of the Bioavailability of Two Controlled Release CP-409,092
Dosage Forms Relative to a Solution Dose in Healthy Male Subjects (270-007-9501), 1998.
Pfizer, Inc. Principal Investigator.
104. Phase I Study of the Clinical Pharmacology of CP-409,092 Following Multiple Dosing in
Healthy Male Subjects Previously Exposed to CP-409,092 (270-010-9501), 1999. Pfizer,
Inc. Principal Investigator.
105. Evaluation of Potential Effects of 20-mg V20001 on Urinary Excretion Ratio of 6-β-
Hydroxycortisol to Cortisol in Patients with Type 2 Diabetes Mellitus (KD98-1001), 1999-
2000. Purdue Pharma L.P. Principal Investigator.
106. An Open-Label Study to Determine the Apparent Time to Steady-State Plasma
Concentrations Following the Application of Buprenorphine Transdermal System (BTDS)
and the Effects of Local Heat on the Plasma Concentrations of Buprenorphine After BTDS
Removal (BP99-0204), 1999. Purdue Pharma L.P. Principal Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
107. An Open-Label Study in Normal Subjects and Subjects Without Gallbladders to Determine
Whether Hydromorphone Undergoes Enterohepatic Recirculation (HD98-0504), 1999.
Purdue Pharma L.P. Principal Investigator.
108. A Single-Dose, Open-Label, Randomized, Three-Period, Six-Sequence, Three-Treatment
Crossover Study Comparing Controlled and Immediate-Release Hydrocodone Tablets and
Assessing the Effect of Food on Controlled-Release Hydrocodone Tablets (HCD-1001),
1999. Purdue Pharma L.P. Principal Investigator.
109. A Phase 1, Open-Label, Randomized, Crossover Study to Assess the Bioequivalence of
Enoxaparin Using an Autoinjector Versus a Standard Injection of 40 mg in Healthy Male and
Female Volunteers (RP54563Q-153), 2000. Aventis Pharmaceuticals Inc. Principal
Investigator.
110. A Double-Blind, Placebo Controlled, Escalating Single Dose Study of the Safety,
Tolerability and Pharmacokinetics of V102862 in Healthy Volunteers (CSC-1001), 2000.
Purdue Pharma L.P. Principal Investigator.
111. Phase II, Double-Blind and Placebo-Controlled Methodology Study to Assess the Effect of
Immediate-Release Paroxetine and Sertraline Using a Controlled-Release Formulation
Prototype on Sexual Function (A0501025), 2000. Pfizer, Inc. Principal Investigator.
112. A Parallel Open-Label Study to Examine Plasma Concentrations of Buprenorphine
Following Reapplication of 10-mg Buprenorphine Transdermal System (BTDS) After
Variable Application Site Rest Periods in Healthy Subjects (BUP1002), 2000. Purdue
Pharma L.P. Principal Investigator.
113. Phase II, Double-Blind and Placebo-Controlled Study to Assess the Effect of CP-122,721 on
Sexual Function (CP-122,721), 2000. Pfizer, Inc. Principal Investigator.
114. A Four-Way Open-Label, Randomized Crossover Study with Talwin® Nx, Single-Dose Oral
Naloxone, Divided-Dose Oral Naloxone, and Intravenous Naloxone in Healthy Subjects,
2001. Purdue Pharma, L.P. Principal Investigator.
115. A Double-Blind Placebo-Controlled, Parallel Group Design Dose-Ranging Study of Three
Doses of Lasofoxifene vs. Placebo for the Treatment of Sexual Dysfunction (Arousal
Disorder) in Postmenopausal Women (A2181015), 2002. Pfizer, Inc. Principal Investigator.
116. A Double-Blind Placebo-Controlled, Parallel Group Design Dose-Ranging Study of Three
Doses of Lasofoxifene vs. Placebo for the Treatment of Sexual Dysfunction (Hypoactive
Desire) in Postmenopausal Women (A2181021), 2002. Pfizer, Inc. Principal Investigator.
117. A Study of the Safety and Efficacy of Lasofoxifene in the Treatment of Vaginal Atrophy in
Postmenopausal Women (A2181012), 2002. Pfizer, Inc. Principal Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
118. Collection of Human Plasma from Healthy Volunteers Following a High-Fat Meal and
Human Serum from Capillary Blood Obtained via Finger Sticks (OXU9002), 2002. Purdue
Pharma L.P. Principal Investigator.
119. A Phase 1, Single-Center, Open-Label, Study to Evaluate The Effect of Multiple Intravenous
Doses of Repifermin on Proliferation and Thickening of the Oral Mucosa and Whole Saliva
Production in Healthy Subjects (KGF-2-M10), 2002. Human Genome Sciences, Inc.
Principal Investigator.
120. Tolerability of Oral Naltrexone in Patients Receiving OxyContin (OCX1001), 2002. Purdue
Pharma, L.P. Principal Investigator.
121. Study to Determine the Stability of Drugs in Clotted Blood from Healthy Volunteers
(OXP9001), 2002. Purdue Pharma, L.P. Principal Investigator.
122. Phase I Study to Determine the Optimal Configuration of ALGRX 3268 (3268-1-100-001),
2002. AlgoRx Pharmaceuticals. Principal Investigator.
123. Tacrolimus Pharmacokinetics in Adult Atopic Dermatitis Patients After Topical
Administration of Tacrolimus Cream 0.01% and 0.03% and Protopic® (Tacrolimus)
ointment 0.03% (01-0-127), 2002. Fujisawa Healthcare, Inc. Principal Investigator.
124. Tacrolimus Pharmacokinetics In Adult Psoriasis Patients After Topical Administration Of
Tacrolimus Cream 0.1% and 0.5% (02-0-139), 2002. Fujisawa Healthcare, Inc. Principal
Investigator.
125. Phase I Study To Quantitate Systemic Lidocaine Exposure after Treatment with ALGRX
3268 (3268-1-101-001), 2002. AlgoRx Pharmaceuticals. Principal Investigator.
126. A Longitudinal Population-Based Study of Peripheral Blood Gene Expression Profiles in
Healthy Volunteers (9999A1-900-WW), 2003. Wyeth Research. Principal Investigator.
127. A Phase 1 Study to Evaluate the Safety and Tolerability of Hydrocodone/Naltrexone/
Acetaminophen (HXA) Combination Tablet in Healthy Subjects (HXA1017), 2003. Purdue
Pharma, L.P. Principal Investigator.
128. Phase I Study to Determine the Optimal Configuration of ALGRX 3268 for the Back of the
Hand (3268-1-102-001), 2003. AlgoRx Pharmaceuticals. Principal Investigator.
129. A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Escalating Single Dose
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a V134444 Oral
Suspension Following AM Administration in Healthy Male Adults (CSH1001), 2003.
Purdue Pharma, L.P. Principal Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
130. An Exploratory Pharmacogenomic Study of Estrogen-Regulated Genes in the Human Vagina
of Postmenopausal Women with Vaginal Atrophy Treated with 17β-estradiol (9800R1-900-
US), 2004. Wyeth Research. Principal Investigator.
131. A Single-center, Open-label, Randomized Investigation in Healthy Volunteers to Determine
the Intranasal Bioavailability of Naltrexone in a Three-way Crossover Study (OCX1009),
2004. Purdue Pharma, L.P. Principal Investigator.
132. A Single-Center, Open-Label, Randomized Investigation in Healthy Volunteers to Determine
the Intranasal and Sublingual Bioavailabilities of Naloxone in a Four-way Crossover Study
(OXN1001), 2004. Purdue Pharma, L.P. Principal Investigator.
133. A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Escalating Single Dose
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a V112054 Liquid Oral
Formulation Following in Healthy Male Adults (CSB1001), 2004. Purdue Pharma, L.P.
Principal Investigator.
134. An Open-Label, Nonrandomized, 2-Period, Fixed Sequence Study to Investigate the Effect of
Single and Repeat Oral Doses of Esomeprazole on the Single-Dose Pharmacokinetics of
AVANDAMET XR (2 tablets of the DiffCORE combination formulation of rosiglitazone
4mg/metformin 1000 mg) in Healthy Volunteers (SB-712753/901), 2004. GlaxoSmithKline.
Principal Investigator.
135. A Phase I, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and
Tolerability of a Single Subfascial/Intramuscular Injection of ALGRX 4975 in Healthy Male
Subjects (4975-1-009-1), 2005. AlgoRx Pharmaceuticals. Principal Investigator.
136. A Randomized Placebo-Controlled Crossover Trial Evaluating the Effect of Naltrexone at 1,
3, and 6 mg Dose Levels on the Abuse Potential of 40 mg Oxycodone in Non-dependent,
Opioid-preferring Subjects (OCX2002), 2005. Purdue Pharma, L.P. Principal Investigator.
137. Phase I, Open-label, Randomized, Two-way Crossover Study in Healthy Subjects to
Determine the Pharmacokinetics and Safety of Aloxi® (Palonosetron HCL I.V.) When
Administered as a 15-minute Infusion Compared to a 30-second Infusion (PALO-04-21),
2005, MGI Pharma, Inc. Principal Investigator.
138. An Open-Label Study to Determine the Sound Emission Levels Produced by a Needle-Free
Injector for Medical Use (ALGRX 3268 ND5.3A) in Healthy Adult Volunteers (3268-1-
005-1), 2005. AlgoRx Pharmaceuticals. Principal Investigator.
139. A 4-Period, Single Ascending Dose, Randomized, Placebo-Controlled, Double-Blind Study
to Evaluate the Safety, Tolerability and Pharmacokinetics in Healthy Postmenopausal
Women of Oral GSK232802, Followed by Staggered Parallel Group, Randomized, Placebo-
Controlled Once Daily Repeated Oral Doses for 4 Weeks (SRM19011), 2005.
GlaxoSmithKline. Principal Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
140. A Randomized, Open-Label, Single-Dose, 14-Treatment, 4-Period, Incomplete Block, Cross
Over Pilot Study in Healthy Male and Female Subjects to Assess the Pharmacokinetic
Characteristics and Relative Bioavailability of Hydromorphone Following Administration of
3 New Palladone Melt Extrusion Multiparticulate Formulations (12 mg) in the Fed and
Fasted State, With and Without Concomitant Ethanol Administration (HMP1015), 2005.
Purdue Pharma L.P. Principal Investigator.
141. Randomized, Placebo-Controlled, Double-Blind, Dose-Escalation Phase I Study of the
Safety, Tolerability and Pharmacokinetics of a Single Intravenous Dose of ETI-204
(AnthimTM) and its Potential Interaction with Ciprofloxacin (AH-101), 2005-2006. Elusys
Pharmaceuticals. Principal Investigator.
142. Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and
Pharmacodynamics of NRI-022 Administered Orally to Healthy Postmenopausal Women
(3190A1-100-US), 2006. Wyeth Research. Principal Investigator.
143. A Randomized, Open-Label, Single-Dose, Four-Way Crossover Pilot Study in Healthy
Subjects to Assess the Pharmacokinetic Characteristics and Relative Bioavailability of
Hydromorphone Following Administration of 3 Different Hydromorphone Tamper
Resistant Formulations (12 mg) in the Fed and Fasted State, Compared to Palladone® (12
mg) in the Fed and Fasted State (HMP1017), 2006. Purdue Pharma L.P. Principal
Investigator.
144. Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single
Intravenous Dose of CBR-2092 in Healthy Volunteers (CBR-2092-001), 2006. Cumbre
Pharmaceuticals Inc. Principal Investigator.
145. An Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole on
the Pharmacokinetics of GSK189075 (KG2108197), 2007. GlaxoSmithKline. Principal
Investigator.
146. A Phase I, Randomized, Double-Blind Study to Assess the Effects of Repeat Oral Dosing
of Ketoconazole on the Pharmacokinetics of Repeat Oral Dosing of Casopitant in Healthy
Subjects (NKV109990), 2007. GlaxoSmithKline. Principal Investigator.
147. An Open-Label, Randomized, Single Dose, Crossover Study to Assess the
Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Modified Release
Formulations of GSK189075 in Healthy Volunteers (KGW111057), 2007. GlaxoSmith-
Kline. Principal Investigator.
148. A Randomized, Single-Blind, Crossover Study to Evaluate the Safety and Onset of Action
of SKY0402 Following Subcutaneous Administration in Healthy Volunteers (SKY0402-
C-106), 2007. Pacira Pharmaceuticals. Principal Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
149. The Pharmacokinetics and Safety of a Single Dose of SEP-225289 Administered With and
Without Food in Healthy Volunteers (360-010), 2007. Sepracor. Principal Investigator.
150. A Study of Selected RNA and Proteomics Characteristics of Normal Healthy Adult and
Pediatric Subjects (0000-RS-0701), 2007. Regeneron Pharmaceuticals, Inc. Principal
Investigator.
151. A Randomized, Double-Blind Study to Evaluate and Compare the Pharmacokinetic and
Pharmacodynamic Properties of Three Manufacturing Lots of SKY0402 Administered via
Local Infiltration to Healthy Volunteers (SKY0402-C-108), 2008. Pacira Pharmaceuticals.
Principal Investigator.
152. An Evaluation of The Safety, Tolerability, and Pharmacodynamic Effects of GSK189075
When Administered with Furosemide or Hydrochlorothiazide (KG2105251), 2008.
GlaxoSmith-Kline. Principal Investigator.
153. A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Escalating Single Dose
Evaluation of the Safety, Tolerability, and Pharmacokinetics of V113741 in Healthy Males
(POA1001), 2008. Purdue Pharma, L.P. Principal Investigator.
154. A Randomized, Single-Blind, Sequential Cohort, Crossover Study to Evaluate the Onset of
Action of SKY0402 Following Local Infiltration in Healthy Volunteers (SKY0402-C-109),
2009. Pacira Pharmaceuticals. Principal Investigator.
155. Randomized, Placebo-Controlled, Double-Blind, Dose-Escalation Phase I Study of the
Safety, Tolerability and Pharmacokinetics of a Single Intravenous Dose of ETI-204
(AnthimTM) (AH-102), 2009. Elusys Pharmaceuticals. Principal Investigator.
156. Phase I Single-Ascending-Dose Crossover Study to Evaluate the Pharmacokinetics of
N1539 Following Intravenous Administration (N1539-01), 2009. Elan Drug Delivery, Inc.
Principal Investigator.
157. A Randomized, Single-Blind, 3-Way Crossover Study Evaluating the Safety, Tolerability,
and Pharmacokinetics of Crushed Intranasal Oxycodone Tamper Resistant Tablets (OTR)
and OxyContin in Healthy Adults (OTR1021), 2009. Purdue Pharma, L.P. Principal
Investigator.
158. A Study in Type 2 Diabetic Subjects of Single and Multiple Doses of Orally Administered
GSK1292263 to Investigate the Safety, Tolerability, Pharmacokinetics and
Pharmacodynamics of the Compound (GPR111598), 2009. GlaxoSmithKline. Principal
Investigator.
159. Randomized Crossover Study to Evaluate the Pharmacokinetics of Hyoscyamine as
Symax® DuoTab and as Symax® SL in Comparison with Hyoscyamine Sulfate Oral
Solution (SOVCT-0024-001), 2009. Capellon Pharmaceuticals, Ltd. Principal
Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
160. A single-center, randomized, open-label, multiple-application study in healthy subjects to
determine the apparent time to steady state of buprenorphine delivered by a transdermal
system (BUP1020), 2010. Purdue Pharma, L.P. Principal Investigator.
161. A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Escalating Single Dose
Evaluation of the Safety, Tolerability, and Pharmacokinetics of V116517 in Healthy Males
(VND1001), 2010. Purdue Pharma, L.P. Subinvestigator.
162. Multiple Dose Study to Evaluate the Steady-State Pharmacokinetics and Food Effect of
Hyoscyamine as Symax® SL and as Symax® DuoTab (SOVCT-00244-002), 2010.
Capellon Pharmaceuticals, Ltd. Principal Investigator.
163. A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Escalating Multiple-
Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of V116517 in Healthy
Male Subjects (VND1002), 2011. Purdue Pharma, L.P. Principal Investigator.
164. A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Escalating Multiple-
Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of V113741 in Healthy
Male Subjects (POA1002), 2011. Purdue Pharma, L.P. Principal Investigator.
165. Phase I Single- and Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability,
and Pharmacokinetics of N1814 Following Intramuscular Administration (N1814-01),
2011. Elan Drug Delivery, Inc. Principal Investigator.
166. A Randomized, Crossover, Pilot Study in Healthy Subjects to Assess the
Pharmacokinetics and Abuse-Deterrent Properties of Oxycodone Immediate-Release
Formulations (OCI1001), 2012. Purdue Pharma, L.P. Principal Investigator.
167. An Assessment of the Safety and Pharmacokinetics of Intranasal (“Snorted”)
Administration of Crushed Oxycodone DETERx™ 40 mg, Oral Administration of Intact
Oxycodone DETERx™ 40 mg, and Intranasal Oxycodone Powder 40 mg (CP-OXYDET-
19), 2013. Collegium Pharmaceutical, Inc. Principal Investigator.
168. A Pilot Study in Healthy Subjects to Compare Objective and Subjective Measurements of
Induced Pain (BNA1001), 2013. Purdue Pharma, L.P. Principal Investigator.
169. A Single-Center, Randomized, Double-Blind Crossover Study to Evaluate the Abuse
Potential, Pharmacokinetics, and Safety of Crushed and Intranasally Administered
Immediate Release Oxycodone (OCI) Tablets in Recreational Opioid Users (OCI1005),
2013. Purdue Pharma, L.P. Principal Investigator.
170. A Pilot Study in Healthy Subjects to Quantitate Reductions in Pain Perception Following
the Administration of OxyContin® (BNA1002), 2014. Purdue Pharma, L.P. Principal
Investigator.
SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)
171. Clinical Trial Protocol for the Establishment of Normative Data of Brain Network
Activation (BNA) Using Evoked Response Potentials in Adolescents, Young Adults and
Adults (ELM-25), 2015. ElMindA, Ltd. Principal Investigator.
GRANTS FROM WITHIN OHIO STATE UNIVERSITY
An Open, Phase I, Multiple-Dose, Pilot Study to Investigate the Concentrations of Ellagic Acid and
Anthocyanins in Plasma, and the Excretion of 8-Oxo-7, 8-Dihydro-2'-Deoxyguanosine (8-OHdG),
in Healthy Volunteers Dosed Orally for 14 Days with a Powdered Formulation of Freeze-Dried
Black Raspberries, 2002. Environmental Health Sciences. Co-Principal Investigator.
An Open-Label, Phase I, Multi-Fixed-Dose, Pilot Study to Investigate the Pharmacokinetics of
Ellagic Acid and Anthocyanins and Safety in Healthy Volunteers Dosed Orally for 7 Days with a
Powdered Formulation of Freeze-Dried Black Raspberries, 2004. Environmental Health Sciences.
Co-Principal Investigator.
FEDERAL GRANTS
Influence of Calcium on Bone Mass Formation During Puberty, NIH, $2,952,426. Co-Investigator
with Velimir Matkovic, M.D., Ph.D., September, 1991 to 1996.
USE PATENTS
Use of gallium nitrate in the treatment of endotoxic shock, filed 1995, in collaboration with Dr.
Nicholas Gerber, Dr. Daniel Mullet, and Mary E. Krecic, awarded 1997.
Treatment of pulmonary inflammation with gallium, filed 1996, in collaboration with Dr. Daniel
Mullet and Dr. Nicholas Gerber, awarded December 23, 1997, patent number 5,700,487.