NCT00937872

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

A Phase I Study to Evaluate the Intravenous Pharmacokinetics and the Absolute Bioavailability of SRT2104 Given as a 250mg Oral Suspension in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Sirtris, a GSK Company · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: 1. Regimen A: A single 10 mL oral dose of 250 mg SRT2104 delivered as a suspension formulation; 2. 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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-11-22
• Primary completion: 2008-12-22
• Completion: 2008-12-22
• First posted: 2009-07-13
• Last updated: 2017-06-05

Locations

1 site across 1 country: United Kingdom