The Effects of Coadministration of Fostamatinib and Warfarin

• Research type

  Research Study

• Full title

  An Open Label,single centre study to assess th pharmacokinetics and pharmacodynamics of warfarin when co-administered with fostamatinib in healthy subjects.

• IRAS ID

  71702

• Contact name

  James Ritter

• Sponsor organisation

  AstraZeneca Pharmaceuticals

• Eudract number

  2010-024471-47

• Research summary

  The drug being investigated in this study is Fostamatinib. Fostamatinib is an unlicensed drug being developed for the treatment of rheumatoid arthritis. The purpose of this study is to determine whether Fostamatinib flunces the breakdown of warfarin and changes its blood thinning effect, and to investigate how safe and tolerable it is when administered with warfarin. Approximately 15 healthy people will participate in the study. The study will take approximately 8 weeks for each subject. There will be a screening period, 1 treatment period and a follow up period (a total of 12 visits to the unit). Visit 1 (screening) will take place within 28 days of Visit 2. There will be 3 residential stays in the unit: 2 lasting 6 days and 5 nights (Visits 2 and 8) and 1 lasting 1 night and 1 day (Visits 4 and 5). The volunteers may be required to stay longer in the unit if their blood results have not returned to normal. The study will take place at Quintiles Drug Research Unit.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IEC01/1

• Date of REC Opinion

  15 Mar 2011

• REC opinion

  Further Information Favourable Opinion