drugset / Trial / NCT01018628

A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2379 in Normal Healthy Male Volunteers

NCT01018628 ↗

Phase 1 Completed 64 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindBasic science

Summary

The main purpose of this study is to assess the safety and pharmacokinetics of SRT2379 (25, 75, 250, 500, 1000, 2000, and 3000 mg/day \[fasted\] and 500 mg/day \[fed\]) in healthy male volunteers. The purpose is also to explore the effect of SRT2379 on plasma concentrations of Fibroblast Growth Factor 21 (FGF21) and to identify other possible biomarkers suitable for future clinical assessment of oral SIRT1 activators.

Timeline

Start
2009-12-07
Primary completion
2010-08-06
Completion
2010-08-06

Publications

  • Background GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing a results summary with a conclusion.

Drugs

EvaluationDrugModalityDoseRoute
Comparator SRT2379 Small molecule 25 mg Oral
Comparator SRT2379 Small molecule 75 mg Oral
Comparator SRT2379 Small molecule 250 mg Oral
Comparator SRT2379 Small molecule 500 mg Oral
Comparator SRT2379 Small molecule 1000 mg Oral
Comparator SRT2379 Small molecule 2000 mg Oral
Comparator SRT2379 Small molecule 3000 mg Oral