Effects of SRT2104 upon immobilisation-induced skeletal muscle atrophy

• Research type

  Research Study

• Full title

  A Phase I, Randomized, Double-Blind, Placebo-Controlled, Clinical Study to Assess the Effects of SRT2104 upon Immobilization-Induced Skeletal Muscle Atrophy in Healthy Human Volunteers. Protocol number SRT-2104-003.

• IRAS ID

  28160

• Contact name

  Roy Taylor

• Sponsor organisation

  Sirtris Pharmaceuticals, Inc.

• Eudract number

  2009-011359-30

• ISRCTN Number

  n/a

• Research summary

  SRT2104 is an Investigational New Drug being developed by a pharmaceutical company called Sirtris Pharmaceuticals, Inc. This study drug has not yet been approved by any regulatory authorities and it is still being studied and tested. The main purpose of this study is to investigate the effect of SRT2104 upon the disuse associated decline in skeletal muscle strength / mass and mitochondrial function (what happens to the body's muscle cells) after receiving 2.0 g of SRT2104 or placebo given in capsule form once a day for 28 days with a 14 day lower leg immobilisation period. Imaging methods and exercise tests will be used in the study to see whether the following measurements change after taking SRT2104 for 28 days with an immobilised lower leg for 14 days.i) muscle strengthii) energy reaching the musclesiii) changes in the structure of the muscleThis study will also investigate the pharmacokinetics, safety and tolerability of 2.0 g of SRT2104 adminstered orally once daily. The investigation of pharmacokinetics of SRT2104 allows us to gather information regarding:i) how long it takes for the drug to be absorbed and detected in the bloodii) how much we can detectiii) how long we can detect it foriv) how often we need to give the drug to maintain a steady amount in the blood.SRT2104 will be given to healthy subjects aged between 18 and 40 years old. Subjects will participate in this single centre study for approximately 79 days. The study consists of 11 outpatient clinic visits and 4 telephone calls (including a pre-screen call to determine whether subjects are interested in participating).

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/101

• Date of REC Opinion

  8 Dec 2009

• REC opinion

  Further Information Favourable Opinion