Clinical Trial Details
| Trial ID: | L1828 |
| Source ID: | NCT00933530 |
| Associated Drug: | Srt2104 |
| Title: | A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Normal Healthy Male Volunteers |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2|Healthy Volunteer |
| Interventions: | DRUG: SRT2104|DRUG: Placebo |
| Outcome Measures: | Primary: Safety and tolerability of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) when administered as a single dose and when administered once daily for 7 consecutive days., Adverse events will be monitored continuously while subjects are on study; safety visits will occur every 7 days for the duration of subject participation.|Characterize the pharmacokinetic profile of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) when administered as a single dose and when administered as once daily for 7 consecutive days., Single dose PK timepoints are: predose and 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24hrs postdose. Multiple dose PK timepoints are: Day1 to Day6 predose, Day7 predose, and 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24hrs postdose. | |
| Sponsor/Collaborators: | Sponsor: Sirtris, a GSK Company | Collaborators: GlaxoSmithKline |
| Gender: | MALE |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 43 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE |
| Start Date: | 2008-05 |
| Completion Date: | 2008-11 |
| Results First Posted: | |
| Last Update Posted: | 2017-05-30 |
| Locations: | GSK Investigational Site, Merthyr Tydfill, Glamorgan, CF48 4DR, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00933530 |
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