To investigate interaction of AZD1656 with warfarin

• Research type

  Research Study

• Full title

  A Phase I, Single Centre, Open-Label, Randomised, Placebo-controlled, Two-Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Warfarin when co-administered with AZD1656 in Type 2 Diabetes Mellitus patients treated with Metformin

• IRAS ID

  50440

• Contact name

  James Ritter

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2010-018697-20

• Research summary

  The drug being tested in this trial is AZD1656. It is being developed as a possible treatment for patients with Type 2 Diabetes Mellitus. This will not be the first time that AZD1656 is given to humans. The purpose of this research is to determine whether AZD1656 flunces the breakdown of warfarin and changes its blood thinning effect, and to investigate how safe and tolerable AZD1656 is when administered with warfarin in Type 2 Diabetes patients. Up to 16 Type 2 Diabetes patients will be enrolled in the study. The study will take place at Quintiles Drug Research Unit, London, Quintiles Ltd. It will involve 5 visits over approximately 8 weeks, and will include 2 residential visits lasting 8 days each. The information gained in this study will help the sponsor to determine whether AZD1656 is suitable for further studies in humans receiving warfarin treatment.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/24

• Date of REC Opinion

  16 Apr 2010

• REC opinion

  Further Information Favourable Opinion