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
The primary objective of this study is to determine the absolute bioavailability of SRT2104 as a 250 mg suspension, and to define the intravenous pharmacokinetics of SRT2104.
The secondary objective of this study is to assess the potential systemic metabolite burden of SRT2104, and to provide plasma and urine samples for subsequent metabolite profiling and identification.
|Diabetes Mellitus, Type 2||Drug: 250 mg SRT2104 Suspension Drug: Carbon-14 radio-labeled SRT2104||Phase 1|
|Study Design:||Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
|Official Title:||A Phase I Study to Evaluate the Intravenous Pharmacokinetics and the Absolute Bioavailability of SRT2104 Given as a 250mg Oral Suspension in Healthy Subjects|
- Absolute bioavailability of SRT2104 250 mg suspension. [ Time Frame: 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 Frame: 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). ]
- Potential systemic metabolite burden of SRT2104 following administration. [ Time Frame: At time points: Pre-dose; 0-12 hrs post dose; 12-24 hrs post dose). ]
|Actual Study Start Date:||November 22, 2008|
|Study Completion Date:||December 22, 2008|
|Primary Completion Date:||December 22, 2008 (Final data collection date for primary outcome measure)|
Single arm with crossover from single dose of oral suspension formulation to single dose intravenous formulation.
Drug: 250 mg SRT2104 Suspension
Single 10 mL oral dose of 250 mg SRT2104 delivered as a suspension formulation.Drug: Carbon-14 radio-labeled SRT2104
Single 10 mL IV dose containing 100 microgram (not more than 250 nCi, 9.25 kBq) Carbon-14 radio-labeled SRT2104, administered by IV infusion over 15 minutes, starting 2 hours and 45 minutes after the oral dose is administered.
This will be a single centre, combined IV and oral single dose, open-label study in healthy male volunteers.
Each subject will receive the following formulations on a single study day:
- Regimen A: A single 10 mL oral dose of 250 mg SRT2104 delivered as a suspension formulation;
- Regimen B: A single intravenous dose of 10 mL containing 100 µg (not more than 250 nCi, 9.25 kBq) Carbon-14 radio-labeled SRT2104 , administered by IV infusion over 15 minutes, starting 2 hours and 45 minutes after the oral dose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937872
|GSK Investigational Site|
|Nottingham, United Kingdom, NG11 6JS|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|