A study to assess the multiple dose pharmacokinetics of SRT2104

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled, phase I clinical study to assess the pharmacokinetics, safety and tolerability of SRT2104 administered as single and multiple doses in the fed state to normal healthy male volunteers

• IRAS ID

  18226

• Sponsor organisation

  Sirtris Pharmaceuticals Inc.

• Eudract number

  2009-010829-39

• ISRCTN Number

  1

• Research summary

  SRT2104 is a drug being developed for the treatment of Type II Diabetes. The purpose of this study is to investigate the pharmacokinetics, safety and tolerability of SRT2104 given in capsule form as a single dose and also as a multiple dose once a day for seven days. Preliminary results from a currently-ongoing clinical trial suggest that SRT2104 is absorbed into the bloodstream to a greater extent when administered to volunteers in the fed state. Therefore in this study SRT2104 will be given following a meal. Investigation of the pharmacokinetics of SRT2104 in this way allows us to gatherinformation regarding:(i) how long it takes for the drug to be absorbed and detected in your blood.(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 your blood.(v) any possible side effects.(vi) how much taking SRT2104 following a meal will affect absorption into the bloodstream when given once a day forseven days versus as a single dose.Subjects that are eligible and choose to participate in the study will receive one of the following treatments:<ul> <li style="color: 2.0 g SRT2104 administered as eight 250 mg hard gelatin capsules</li> <li style="color: Eight placebo capsules</li></ul>The above treatments will be administered on two separate occasions: once as a single dose and then again approximately two weeks later, as a multiple dose (i.e. once a day for 7 days). All doses will be administered within 30 minutes of the start of consumption of a standard meal.Subjects?? participation in the study will last about seven weeks and will involve a total of nine visits to the research unit.

• REC name

  Wales REC 2

• REC reference

  09/WSE02/13

• Date of REC Opinion

  16 Mar 2009

• REC opinion

  Favourable Opinion