A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Normal Healthy Male Volunteers

Diabetes Mellitus, Type 2 Clinical Trial

Official title: A Phase I Randomized, Placebo-Controlled, Single-Blind, Multiple-Dose, Dose-Escalation Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Normal Healthy Male Volunteers

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) in healthy male volunteers when administered after a single dose and once daily for 7 consecutive days.

The purpose is also to characterize the pharmacokinetic profile of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) after a single dose and multiple administrations in healthy male volunteers.

Clinical Trial Description

Prospective, single center, clinical study of SRT2104 administered orally. Randomized, placebo-controlled, single-blind, multiple-dose, dose-escalation inpatient/outpatient study to assess the safety and pharmacokinetics (PK) of SRT2104 in healthy male volunteers. Forty-two (42) subjects aged 18-55, who fulfill the inclusion/exclusion criteria, will be enrolled in this study. Seven cohorts of six subjects each will be examined. Subjects within each cohort will be randomized 4:2 to receive SRT2104 at one of seven escalating doses (A, B, C, D, E, F, or G), likely to be 0.03, 0.1, 0.25, 0.5, 1.0, 2.0, or 3.0 g/day or placebo. Two subjects will be dosed on Day 1 of the single dose period with one subject receiving active treatment and one subject receiving placebo. The remainder of subjects within each cohort will be dosed on Day 2 of the single dose period with three subjects receiving active treatment and one subject receiving placebo assuming that no safety issues arise in the two subjects dosed on Day 1. Subjects will remain on a fixed dose of test material for all dosing days in the study.

Each cohort of subjects will be dosed sequentially approximately two weeks apart for the single dose period, and return to the clinic approximately one week after their single dose administration to receive 7 consecutive days of dosing for the multiple dose period. Each cohort of subjects in the multiple dose period will be dosed sequentially, approximately, one week apart, allowing for a comprehensive safety assessment prior to initiation of an escalated dose in a subsequent cohort. In the event of suspected drug related toxicity, as determined by the principal investigator, sponsor, and an independent medical monitor, at a dose of 0.03 g/day, all subjects in the 0.03 g/day cohort will discontinue dosing, and the subsequent cohort will receive 0.01 g/day for seven consecutive days. Safety and PK-related data will be reviewed for the 0.01 g/day dose level, and no subsequent cohorts will be enrolled into the study.

Subjects will sign the informed consent form at the screening visit. If eligible and willing to participate, subjects will enter into the study. Subjects will have fasted for at least 10 hours overnight and be randomized to receive SRT2104 or placebo (test material). Subjects will be required to stay overnight at the study center for two nights during the single dose period of the study and subsequently, for the duration of the seven-day multiple dose period to assess safety and to gather required PK samples. Subjects will be asked to return to the study center for an End of Study safety assessment 1 week after they complete the multiple dose period.

Dose escalation will be dependent on safety parameters (physical examination findings, vital signs, ECG studies, adverse events and laboratory values) and PK data. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy Volunteer

• NCT number: NCT00933530
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 1
• Start date: May 2008
• Completion date: November 2008