A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral SRT2104 Capsules Administered to Healthy Elderly Subjects for 28 Days

Summary

The primary objective is to determine the pharmacokinetics, safety and tolerability of SRT2104 in healthy elderly subjects following single and 28 days dosing. The secondary objectives of the study are: 1. To contrast changes in leg muscle function following repeat doses of SRT2104 or placebo: Endurance exercise tolerance 31P MRS measures of mitochondrial oxidative capacity in the gastrocnemius muscle 2. To test for a change in the ratio of visceral to subcutaneous body fat following repeat doses of SRT2104 relative to placebo using MRI 3. To estimate any changes in insulin sensitivity (using mOGTT) following repeat doses of SRT2104 or placebo 4. To test for dose-related effects on the exploratory pharmacodynamic measures above

Timeline

Start

2009-10-01

Primary completion

2010-04-27

Completion

2010-04-27

Publications

• Background Libri V, Brown AP, Gambarota G, Haddad J, Shields GS, Dawes H, Pinato DJ, Hoffman E, Elliot PJ, Vlasuk GP, Jacobson E, Wilkins MR, Matthews PM. A pilot randomized, placebo controlled, double blind phase I trial of the novel SIRT1 activator SRT2104 in elderly volunteers. PLoS One. 2012;7(12):e51395. doi: 10.1371/journal.pone.0051395. Epub 2012 Dec 20.

Drugs

Indications