Clinical Study to Assess the Effects of SRT2104 and Prednisolone on Biomarkers in Blood in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 6, 2009

Primary Completion Date

June 12, 2009

Study Completion Date

June 12, 2009

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

Placebo

Matching placebo is supplied containing microcrystalline cellulose (Avicel PH 105). Placebo will be administered as eight matched capsules.

DRUG

0.25g SRT2104

SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg. The 0.25g SRT2104 treatment visit will be administered as one SRT2104 capsule with 7 placebo capsules. Dosing will take place during one of the 6 treatment visits.

DRUG

Prednisolone

During the last treatment period, subjects will receive 30 mg open-label prednisolone.

DRUG

0.5g SRT2104

SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg. The 0.5g SRT2104 treatment visit will be administered as two SRT2104 capsules with 6 placebo capsules. Dosing will take place during one of the 6 treatment visits.

DRUG

1g SRT2104

SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg. The 1g SRT2104 treatment visit will be administered as four SRT2104 capsules with four placebo capsules. Dosing will take place during one of the 6 treatment visits.

DRUG

2g SRT2104

SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg. The 2g SRT2104 treatment visit will be administered as eight SRT2104 capsules. Dosing will take place during one of the 6 treatment visits.

Trial Locations (1)

CF48 4DR

GSK Investigational Site, Merthyr Tydfill

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00920660 - Clinical Study to Assess the Effects of SRT2104 and Prednisolone on Biomarkers in Blood in Healthy Volunteers | Biotech Hunter | Biotech Hunter