Multi way crossover of SRT2104 and prednisolone on biomarkers

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, multi-way crossover study to assess the effects of single oral doses of SRT2104 and prednisolone on biomarkers in healthy volunteers.

• IRAS ID

  18647

• Sponsor organisation

  Sirtris Pharmaceuticals Inc, a Glaxo Smith Kline company.

• Eudract number

  2009-010620-25

• ISRCTN Number

  not submitted

• Research summary

  SRT2104 is a drug being developed for the treatment of COPD. The purpose of this study is to investigate how the body's affected by SRT2104 (given in capsule form as a single dose) and the marketed drug prednisolone. We will do this by taking blood samples to measure levels of certain chemicals called TNF-alpha, IL-6, IL-8 and IL-1beta that are found naturally in subjects' bodies. These tests will give an indication as to whether the drug may be effective in the treatment of COPD. Subjects will also have transcriptnomic samples obtained in the event that the TNF alpha analysis data are inconclusive. SRT2104 plasma concentration levels will also be measured.If subjects agree to take part in this study, they will also be asked to provide an optional 10 ml blood sample (about 2 teaspoons) for genotyping (the method used to study genes [DNA]). Declining to provide this sample will in no way affect their ability to take part in this study

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/44

• Date of REC Opinion

  9 Apr 2009

• REC opinion

  Further Information Favourable Opinion