To investigate multiple ascending doses of AZD8329

• 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 AZD8329 after Administration of Multiple Ascending Doses in Abdominally Obese but otherwise Healthy Male Subjects

• IRAS ID

  61534

• Contact name

  James Ritter

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2010-021054-18

• Research summary

  The drug being tested in this trial is AZD8329. The primary indication for AZD8329 is planned to be type 2 diabetes mellitus, but there are also potential alternative indications such as obesity and dyslipidemia(abnormal amounts of fat in the blood).The main aim of this proposal is to investigate the safety and tolerability of AZD8329 following administration of multiple doses. In addition we will evaluate how this drug is handled by the body, whether it influences metabolism in fatty tissue and in the liver, and whether it influences the levels of a panel of hormones. We will assess weight, waist circumference and waist/hip ratio, and the sensitivity of the tissues to the action of insulin. We will collect and store blood and tissue samples for potential future exploratory research on intermediary metabolism and on AZD8329. The study design allows a step-wise increase of dose with thorough safety monitoring to ensure the safety of the subjects. A safety monitoring committee will decide whether the dose can be increased at each step. Abdominally obese but otherwise healthy subjects aged 20-50 will be informed about the study and invited to participate. Up to 45 consenting subjects will be recruited. Following a screening period (starting with Visit 1) there will be two admissions to the Clinical Unit, followed by a follow up visit 14-17 days after the last dose. Analyses of safety and tolerability data, and the other measurements, will be summarised descriptively in tables, listings and graphs, as appropriate. The information gained will help the sponsor of this study to determine whether AZD8329 is suitable for further studies in humans.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/63

• Date of REC Opinion

  21 Sep 2010

• REC opinion

  Further Information Favourable Opinion