A study to assess the pharmacokinetics of SRT2104

• Research type

  Research Study

• Full title

  A phase I randomized, open-label, clinical study to assess the effect of food and gender on the pharmacokinetics of SRT2104 administered as an oral suspension or capsule formulation to normal healthy volunteers

• IRAS ID

  12683

• Sponsor organisation

  Sirtris Pharmaceuticals Inc.

• Eudract number

  2008-007364-41

• 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 two different formulations of SRT2104, one where it is given in liquid form to drink, and one where it is given as capsules to swallow. Investigation of the pharmacokinetics of SRT2104 in this way allows us to gather information regarding:(i)how long it takes for the drug to be absorbed and detected in the blood. (ii)how much can be detected.(iii)how long it can be detected for.(iv)how often the drug needs to be given to maintain a steady amount in the blood.(v)any possible side effects. (vi)Any differences in (i) to (v) between SRT2104 given as a liquid or given as capsules.In addition, this study is also intended to determine whether taking SRT2104 with food versus on an empty stomach affects the pharmacokinetics of SRT2104.In order to do this, following determination of eligibility at a screening visit (conducted within 21 days prior to first dose), each eligible volunteer will be given the same single dose (500 mg) of SRT2104 under four different conditions:1.once as SRT2104 in liquid form on an empty stomach.2.once as SRT2104 in liquid form following a standard meal3.once as SRT2104 in capsule form on an empty stomach4.once as SRT2104 in capsule form following a standard meal.Each occasion will be approximately one week apart. Blood will be collected to provide information regarding the pharmacokinetics of SRT2104 described above. The safety of SRT2104 will be assessed through the continuous monitoring for adverse events, in addition to periodic measurement of vital signs (heart rate, blood pressure, breathing rate and oral temperature) and ECGs to measure the activity of the heart. Blood samples will also be taken during the study to perform laboratory safety analyses. Volunteers will be required to remain in the clinical research unit for 3 nights, on 4 separate occasions (total of 12 nights).An End of Study follow up visit will be conducted between 7 and 12 days after the last dose of SRT2104.

• REC name

  Wales REC 2

• REC reference

  08/WSE02/55

• Date of REC Opinion

  15 Dec 2008

• REC opinion

  Favourable Opinion