Effect of SRT2379 on Endotoxin-Induced Inflammation
SRT2379 is a potent small molecule activator of SIRT1 that has been found to inhibit systemic inflammation induced by intravenous injection of lipopolysaccharide (LPS) in mice. The objective of this study is to test if SRT2379 may be a novel compound for the treatment of inflammatory disorders in man.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||A Phase I Study to Evaluate a Single Oral Dose of SRT2379 on the Endotoxin Induced Inflammatory Response in Healthy Male Subjects|
- To determine if a single dose of SRT2379 attenuates the inflammatory response in normal healthy male subjects after exposure to low-dose endotoxin (LPS). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- To determine PK of SRT2379 in normal healthy male subjects exposed to low-dose endotoxin (LPS). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- To determine the safety profile of SRT2379 in healthy male subjects exposed to low-dose endotoxin (LPS). [ Time Frame: 10 days ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Active Comparator: 1.0 g SRT2379
Single dose of 1.0g of SRT2379
SRT2379 will be supplied as hard gelatin capsules, with each containing 250mg.
Placebo Comparator: 1.0 g Placebo
Single dose of 1.0g of placebo
Matching placebo will be supplied as hard gelatin capsules, with each containing an appropriate amount of placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262911
|GSK Investigational Site|
|Amsterdam, Netherlands, 1105 AZ|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|