drugset / Trial / NCT01018628
A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2379 in Normal Healthy Male Volunteers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |