Randomised, Multiple-Dose, Dose-Escalation Clinical Study of SRT2379

• Research type

  Research Study

• Full title

  A Phase I Randomized, Placebo-Controlled, Single-Blind, Multiple-Dose, Dose-Escalation Clinical Study to Assess the Safety and Pharmacokinetics of SRT2379 in Normal Healthy Male Volunteers

• IRAS ID

  35906

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Sirtris Pharmaceuticals Inc

• Eudract number

  2009-014797-17

• ISRCTN Number

  1

• Research summary

  SRT2379 is being developed primarily for the treatment of Type II Diabetes. This is the first time that SRT2379 has been given to human volunteers. The purpose of this study is therefore to investigate the safety and tolerability of SRT2379 and how it is handled by the body. To do this, each group of volunteers will be given a daily dose of SRT2379, for one day and a daily dose for seven days. The dose will increase for each group of volunteers. This study design will enable us to investigate:(i) how long it takes for the drug to be absorbed and detected. (ii) how much we can detect.(iii) how long we can detect it for.(iv) how often we need to give the drug to maintain a steady amount in the body. (v) any possible side effects. We will also be looking at how the body's affected by SRT2379. We will do this by taking blood samples to measure levels of a chemical called Fibroblast Growth Factor 21(FGF21) that is found naturally in subject's bodies. In one group of volunteers, we will look at the effects of food on SRT2379 and FGF21 levels before and after a high fat breakfast. We may also look if required in the blood for levels of adiponectin, hsCRP, insulin and other chemicals that may give us an idea of whether SRT2379 will be effective in the treatment of Type II Diabetes and other possible therapeutic areas (so called Bio-markers).

• REC name

  Wales REC 2

• REC reference

  09/WSE02/57

• Date of REC Opinion

  13 Nov 2009

• REC opinion

  Favourable Opinion