Imatinib PK study QTI571A2102

• Research type

  Research Study

• Full title

  A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients

• IRAS ID

  70780

• Contact name

  Gerry Coghlan

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-021344-17

• ISRCTN Number

  n/a

• Research summary

  Pulmonary arterial hypertension (PAH) is a serious lifelimiting condition caused by an increase in the pressure within the arteries that carry blood from the heart to the lungs. This puts strain on the right side of the heart, resulting in heart failure and premature death. Although several therapies are available, there is no known cure. It is estimated that approximately 2000 people in the UK suffer from PAH. This is an open label trial to study the effects of imatinib on the body when used in conjunction with bosentan and sildanafil in PAH patients. Bosentan and sildenafil are both used in the treatment of PAH. The study will take place over three treatment periods: days 1-8 when the patients will receive bosentan and sildenafil only; days 9-36 when the patients will receive bosentan, sildenafil and 200mg imatinib and days 37-43 when the patients will receive bosentan, sildenafil and 400mg imatinib.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  11/SC/0027

• Date of REC Opinion

  18 Apr 2011

• REC opinion

  Further Information Favourable Opinion