To investigate multiple ascending doses of AZD7687

• Research type

  Research Study

• Full title

  A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of oral AZD7687 after Administration of Multiple Ascending Doses in Overweight to Obese but otherwise Healthy Male Subjects.

• IRAS ID

  50208

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2010-019112-21

• Research summary

  The drug being tested in this trial is AZD7687. It is being developed as a possible treatment for patients with Type 2 diabetes mellitus and for weight reduction and/or weight maintenance. This will be the first study with multiple dose administration in human volunteers. The purpose of this study is to determine how safe and well tolerated AZD7687 is after repeated dosing, to get information on how this substance is absorbed, distributed and eliminated from the body. We may also investigate whether there is a tendency for weight reduction and waist circumference during treatment with AZD7687. Up to 45 healthy overweight to obese men aged 20 to 45 will be enrolled in the study. The study will take place at Quintiles Drug Research Unit, Quintiles Ltd. It will involve 3 visits over approximately 9 weeks, and will include 1 residential visit lasting 13 nights respectively. The information gained in this study will help the sponsor of this study to determine whether AZD7687 is suitable for further studies in humans.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/20

• Date of REC Opinion

  9 Apr 2010

• REC opinion

  Further Information Favourable Opinion