Clinical Trial Details
| Trial ID: | L6123 |
| Source ID: | NCT00938275 |
| Associated Drug: | 0.5g Srt2104 |
| Title: | A Clinical Study to Assess the Effect of Food and Gender on the Pharmacokinetics of SRT2104 Administered as an Oral Suspension or Capsule Formulation to Normal Healthy Volunteers |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: 0.5g SRT2104 |
| Outcome Measures: | Primary: Characterize and compare the pharmacokinetic profile of a single 500 mg dose of SRT2104 administered as an oral suspension and as a capsule formulation., PK time points: pre-dose (0 hrs); 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0. 6.0, 8.0, 10, 12, 15, 24, 36, 48, 72 hours post dose. | Secondary: Assess the safety and tolerance of SRT2104., AEs, concomitant medications (as applicable), vital signs, physical examinations, laboratory parameters, and ECG parameters will be collected for the duration of the study. |
| Sponsor/Collaborators: | Sponsor: Sirtris, a GSK Company | Collaborators: GlaxoSmithKline |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 20 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE |
| Start Date: | 2009-01-20 |
| Completion Date: | 2009-03-27 |
| Results First Posted: | |
| Last Update Posted: | 2017-07-21 |
| Locations: | GSK Investigational Site, Merthyr Tydfill, Glamorgan, CF48 4DR, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00938275 |
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