Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of SRT2104 Administered to Normal Healthy Male Volunteers

Diabetes Mellitus, Type 2 Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase I Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of SRT2104 Administered as Single and Multiple Doses in the Fed State to Normal Healthy Male Volunteers

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the pharmacokinetic profile, 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.

Clinical Trial Description

This is a prospective, single center, clinical study of SRT2104 administered orally; a randomized, inpatient/outpatient study to assess the safety and pharmacokinetics (PK) of SRT2104 in healthy male volunteers. Ten (10) male subjects, aged 18-60, who fulfil the inclusion/exclusion criteria, will be enrolled in this study. Subjects will receive either a dose of 2.0 g SRT2104 (administered as eight 250 mg capsules) or placebo on eight occasions during the study; once as a single dose (study day 1) during Treatment Period 1, and once per day for seven consecutive days (study days 15 to 21) during Treatment Period 2. Every administration of SRT2104 will be in the fed state (i.e. within 30 minutes following the start of consumption of a standard meal).

Subjects will be asked to sign the informed consent form at the screening visit. If eligible and willing to participate, subjects will enter into the study. Subjects will be required to attend the research unit on eight separate occasions during the study, in addition to the screening visit. Treatment Period 1 requires the subject to attend the unit for two consecutive overnight stays (Day -1 and Day 1), after which subjects will be discharged from the unit on Day 2 (following the 24 hr post-dose PK blood sample). Subjects will then be required to return to the unit for PK blood samples to be obtained on Day 3 (48 hr post-dose), Day 4 (72 hr post-dose) and Day 8 (168 hr post-dose). Following a washout period of seven days, subjects will be required to attend the unit for Treatment Period 2, which will involve eight consecutive overnight stays (Days 14 to 21), after which subjects will be discharged from the unit on Day 22 (following the 24 hr post-dose PK blood sample). Subjects will then be required to return to the unit for PK blood samples to be obtained on Day 23 (48 hr post-dose), Day 24 (72 hr post-dose) and Day 28 (168 hr post-dose).

Subjects will be randomised 8:2 (active:placebo) to receive one of the following two treatments for the duration of the study:

A. 2.0 g SRT2104 administered as eight 250 mg hard gelatin capsules B. Eight placebo capsules

Water will be restricted from 1 hour prior to dosing until 1 hour post-dose. Subjects will receive SRT2104 within 30 minutes following the start of consumption of a standardized non-high-fat meal (approximately 650 kcal with approximately 30% of calories derived from fat). A light lunch will be provided 4 hours post-dose, an evening meal approximately 8 hours post dose and a snack approximately 12 hours post dose.

Subjects will be discharged from the study on Day 28 after the 168 h PK sample has been obtained, all required safety assessments have been performed, and the subject has been confirmed clinically stable by the investigator/identified sub-investigator. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

• NCT number: NCT00933062
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 1
• Start date: March 23, 2009
• Completion date: May 12, 2009