Phase I, Randomised, Placebo Controlled, Crossover Study with SRT2104

• Research type

  Research Study

• Full title

  A Phase I, Randomized, Placebo-Controlled, Crossover Clinical Trial to Assess the Safety of Oral SRT2104 and its Effects on Vascular Dysfunction in Otherwise Healthy Cigarette Smokers and Subjects with Type 2 Diabetes Mellitus

• IRAS ID

  39867

• Contact name

  David Newby

• Sponsor organisation

  Sirtris - a GSK company

• Eudract number

  2009-016765-28

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  SRT2104 is an Investigational New Drug being developed by Sirtris Pharmaceuticals. The study drug is under investigation for the treatment of Type II Diabetes Mellitus as well as other potential conditions.This study is designed to examine the safety and activity of SRT2104 on vascular dysfunction when dosed once daily for 28 consecutive days in male and female subjects (of non-child bearing potential) who have type 2 diabetes mellitus or otherwise healthy cigarette smokers. Both of these populations may have dysfunction or damage to their endothelial cells that line blood vessels. This could potentially lead to increased risks of cardiovascular disease, blood flow restriction and the hardening of these vessels. SRT2104 is thought to work by causing the body to make specific proteins in the cells of the body from a gene called "Sirt1". These proteins may affect the lining of the blood vessels and reduce the damage caused by having diabetes and smoking cigarettes. This study will asses the safety of SRT2104 and its activity in the body on potentially improving vascular function and blood flow.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  09/H0505/150

• Date of REC Opinion

  12 Jan 2010

• REC opinion

  Further Information Favourable Opinion