Study to Evaluate the Safety, Pharmacokinetics and Tolerability of BMS-708163

Phase 1 Completed 116 enrolled Bristol-Myers Squibb

RandomizedParallel-groupDouble-blindBasic science

Summary

The primary objective is to assess the safety and tolerability of a single oral dose of BMS-708163 in healthy young male subjects and in elderly male and female subjects.

Timeline

Start: 2007-06
Primary completion: 2009-03
Completion: 2009-03

Publications

Tong G, Wang JS, Sverdlov O, Huang SP, Slemmon R, Croop R, Castaneda L, Gu H, Wong O, Li H, Berman RM, Smith C, Albright CF, Dockens RC. Multicenter, randomized, double-blind, placebo-controlled, single-ascending dose study of the oral gamma-secretase inhibitor BMS-708163 (Avagacestat): tolerability profile, pharmacokinetic parameters, and pharmacodynamic markers. Clin Ther. 2012 Mar;34(3):654-67. doi: 10.1016/j.clinthera.2012.01.022. Epub 2012 Feb 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avagacestat	Small molecule	0.3 mg	Oral
Subject	Avagacestat	Small molecule	1.5 mg	Oral
Subject	Avagacestat	Small molecule	5 mg	Oral
Subject	Avagacestat	Small molecule	15 mg	Oral
Subject	Avagacestat	Small molecule	50 mg	Oral
Subject	Avagacestat	Small molecule	100 mg	Oral
Subject	Avagacestat	Small molecule	200 mg	Oral
Subject	Avagacestat	Small molecule	400 mg	Oral
Subject	Avagacestat	Small molecule	800 mg	Oral

Study to Evaluate the Safety, Pharmacokinetics and Tolerability of BMS-708163

Summary

Timeline

Publications

Drugs

Indications