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

PHASE1CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

November 30, 2008

Study Completion Date

November 30, 2008

Conditions
Diabetes Mellitus, Type 2Healthy Volunteer
Interventions
DRUG

SRT2104

SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, or 3.0 g/day) will be supplied as a powder which will be prepared by the Pharmacist/designee into a liquid suspension. The dosing vehicle is 1% (by weight) hypromellose acetate succinate in water, which is used as a suspension aid and a dispersant for the SRT2104. Test material will be administered orally, in a single dose and subsequently, once daily for seven consecutive days. A trained staff member will prepare individual solutions of test material that the subject will drink once daily in the clinic following a 10-hour (minimum) fast.

DRUG

Placebo

Placebo (at the matched dosage as SRT2104) will be supplied as a powder which will be prepared by the Pharmacist/designee into a liquid suspension. Placebo will consist of titanium dioxide USP and prepared for oral administration identically to the SRT2104 investigational product. Test material will be administered orally, in a single dose and subsequently, once daily for seven consecutive days. The subjects enrolled will be blinded to treatment assignment. A trained staff member will prepare individual solutions of test material that the subject will drink once daily in the clinic following a 10-hour (minimum) fast.

Trial Locations (1)

CF48 4DR

GSK Investigational Site, Merthyr Tydfill

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Sirtris, a GSK Company

INDUSTRY

NCT00933530 - A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Normal Healthy Male Volunteers | Biotech Hunter | Biotech Hunter