Clinical Trial Details
| Trial ID: | L2917 |
| Source ID: | NCT00937872 |
| Associated Drug: | 250 Mg Srt2104 Suspension |
| Title: | A Clinical Study to Evaluate the Pharmacokinetics and the Absolute Bioavailability of SRT2104 Given as a 250mg Oral Suspension and Intravenous Microdose of 100 µg Carbon-14 Radio-labeled SRT2104 in Healthy Male Subjects |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: 250 mg SRT2104 Suspension|DRUG: Carbon-14 radio-labeled SRT2104 |
| Outcome Measures: | Primary: Absolute bioavailability of SRT2104 250 mg suspension., Time points to measure the bioavailability of SRT2104 oral 250 mg suspension: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72 hrs following administration.|Define the intravenous pharmacokinetics of SRT2104., Time points to define the IV PK of SRT2104: Just before infusion (0); During infusion (5, 10 min); Post infusion (5, 10, 20, 30, 45 min and 1, 2, 3, 4, 6, 8, 10, 12, 15, 21, 45, 69 hours). | Secondary: Potential systemic metabolite burden of SRT2104 following administration., At time points: Pre-dose; 0-12 hrs post dose; 12-24 hrs post dose). |
| Sponsor/Collaborators: | Sponsor: Sirtris, a GSK Company | Collaborators: GlaxoSmithKline |
| Gender: | MALE |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 9 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: |Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE |
| Start Date: | 2008-11-22 |
| Completion Date: | 2008-12-22 |
| Results First Posted: | |
| Last Update Posted: | 2017-06-05 |
| Locations: | GSK Investigational Site, Nottingham, NG11 6JS, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00937872 |
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