drugset / Trial / NCT00933530

A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Normal Healthy Male Volunteers

NCT00933530

Phase 1 Completed 43 enrolled Sirtris, a GSK Company GlaxoSmithKline · collab
RandomizedCrossoverSingle-blindBasic science

Summary

The purpose of this study is to determine the safety and tolerability of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) in healthy male volunteers when administered after a single dose and once daily for 7 consecutive days. The purpose is also to characterize the pharmacokinetic profile of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) after a single dose and multiple administrations in healthy male volunteers.

Timeline

Start
2008-05
Primary completion
2008-11
Completion
2008-11

Drugs

EvaluationDrugModalityDoseRoute
Subject SRT2104 Small molecule 0.01 g Oral
Subject SRT2104 Small molecule 0.03 g Oral
Subject SRT2104 Small molecule 0.1 g Oral
Subject SRT2104 Small molecule 0.25 g Oral
Subject SRT2104 Small molecule 0.5 g Oral
Subject SRT2104 Small molecule 1 g Oral
Subject SRT2104 Small molecule 2 g Oral
Subject SRT2104 Small molecule 3 g Oral