SRT 3025, First-time-in-human, dose-escalation - Metabolic disease

• Research type

  Research Study

• Full title

  A Randomized, Placebo-Controlled, Single-Blind, Dose-Escalation, First-Time-in-Human Study to Assess the Safety and Pharmacokinetics of Single and Repeat Doses of SRT3025 in Normal Healthy Volunteers

• IRAS ID

  78347

• Sponsor organisation

  Sirtris Pharmaceuticals, Inc.

• Eudract number

  2011-000835-99

• Research summary

  The medication being studied does not yet have a name and is only known by a number, SRT3025. The study will investigate how safe the study drug is and how well it is tolerated, taken up, metabolised and distributed through the body (pharmacokinetics (PK)). The effect of food on SRT3025 PK will also be looked at. The study is divided in 2 parts: Part 1A: 6 groups will receive single increasing doses. Part 1B: Up to two groups to investigate the effect of a moderate fat/calorie meal on single dose PK. Part 2A: Up to three groups to receive 14-day repeat doses chosen from Part 1A safety, tolerability, and PK results. Part 2B: Up to two groups to receive 14-day repeat doses with a moderate fat/calorie meal.In Part 1 - 8 participants will be enrolled per group (6 - SRT3025 and 2 - placebo)(a dummy drug that looks like SRT3025 but contains no active ingredients). Part 2 consists of 6 SRT3025 subjects only. In Part 1 Group 1: 2 participants will be dosed on Day 1 (1 - SRT3025 and 1 - placebo), assuming no safety issues arise, the remaining 6 participants within Group 1 will be dosed on Day 2 (5 - SRT3025 and 1 - placebo). Thereafter, all participants in will be dosed on the same day.This study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital. Blood will be collected for pharmacokinetic analysis. Vital signs and ECG will be monitored. Pre and postdose haematology, biochemistry and urinalysis will be performed.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0068

• Date of REC Opinion

  17 May 2011

• REC opinion

  Further Information Favourable Opinion