Clinical Trial Details
| Trial ID: | L2981 |
| Source ID: | NCT00933062 |
| Associated Drug: | Srt2104 |
| Title: | Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of SRT2104 Administered to Normal Healthy Male Volunteers |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: SRT2104|DRUG: Placebo |
| Outcome Measures: | Primary: To assess the plasma pharmacokinetic profile of SRT2104 following administration of single and multiple oral doses (once a day for seven days) at a single dose level (2.0 g/day) to healthy male volunteers in the fed state., Plasma samples will be collected pre-dose (0 h) and at the following time points following dosing on Days 1 and 21: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 48, 72 and 168 h post-dose. | Secondary: To assess the safety and tolerability of SRT2104 following administration of single and multiple oral doses (once a day for seven days) at a single dose level (2.0 g/day) to healthy male volunteers in the fed state., Safety will be monitored by AEs, VS, physical exam, labs and ECGs during the study. |
| Sponsor/Collaborators: | Sponsor: GlaxoSmithKline |
| Gender: | MALE |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 10 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE |
| Start Date: | 2009-03-23 |
| Completion Date: | 2009-05-12 |
| Results First Posted: | |
| Last Update Posted: | 2017-07-07 |
| Locations: | GSK Investigational Site, Merthyr Tydfill, Glamorgan, CF48 4DR, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00933062 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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