The Body Covers: The 6th Conference on Retroviruses and Opportunistic Infections
Abstract No. 604: BMS-232632: Single and Multiple Oral Dose Safety and Pharmacokinetic Study in Healthy Volunteers
February 3, 1999
Phase I data (first in man study) was presented evaluating the pharmacokinetics of five different doses (once daily doses of either 100mg, 300, 600, 900, 1200) in 40 healthy volunteers, in a double-blind, placebo-controlled and randomized study. In each dose group 6 were given drug and 2 were given placebo. Bioavailabilty of a capsule formulation averaged 68% relative to that of an oral solution and was tolerated well. A few cases of diarrhea and GI discomfort were reported. Isolated asymptomatic increases in serum bilirubin were seen mostly in the groups receiving 500 and 600 mg daily. The group of subjects taking doses above 300mg daily demonstrated serum concentrations of drug that were above the EC50 for HIV for more than a 24 hour period, distinguishing this agent for once daily dosing. To date, dose ranges of 200-600 mg daily have been evaluated over a two week period, and treatment-related adverse events were mild, reversible and consisted of asymptomatic elevations of unconjugated bilirubin in one third of patients. Plans are being made to study this drug further in larger human trials.Abstract: BMS-232632: Single and Multiple Oral Dose Safety and Pharmacokinetic Study in Healthy Volunteers
Authored by: E.M. O'Mara, J. Smith, S.J. Olsen, T. Tanner, A.E. Schuster, and S. Kaul
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