NCT01416376

Effect of Multiple Dose Levels of SRT2379 on Endotoxin-Induced Inflammation

A Double Blind, Placebo Controlled, Phase I Dose-ranging Study to Evaluate the Activity of SRT2379 on Endotoxin Induced Inflammatory Response in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Sirtris, a GSK Company · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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 determine the effect of a single administration of SRT2379, at multiple-dose levels, on the inflammatory response to low dose endotoxin.

Conditions

• Sepsis

Interventions

Type	Name	Description
DRUG	SRT2379	SRT2379 is supplied as hard gelatin capsules containing either 25mg or 250mg free-base equivalent of SRT23790 drug substance as its succinate salt.
DRUG	Placebo	For the placebo capsules, the SRT2379 drug substance will be replaced by microcrystalline cellulose (Avicel PH200) to visually match the SRT2379 investigational product.

Timeline

• Start date: 2011-08-30
• Primary completion: 2011-12-12
• Completion: 2011-12-12
• First posted: 2011-08-15
• Last updated: 2017-06-15

Locations

1 site across 1 country: Netherlands