Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension Pulmonary Vascular Resistance Imatinib Bosentan Sildenafil
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 21
Healthy volunteers: no

Brief summary:
The purpose of this study was to investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan and sildenafil at steady state when co-administered to participants with pulmonary arterial hypertension.

Detailed description:

Arms:
arm 1: Participants received treatment with bosentan 125 milligrams (mg) twice daily and sildenafil thrice daily for 8 days in treatment period 1. Participants were on the same sildenafil dose level (20, 40, 50 or 60 mg) they had been at study entry which was well tolerated in conjunction with bosentan. Following treatment period 1, the participants received concomitant treatment of oral imatinib 200 mg daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 2. Following treatment period 2, the participants received concomitant treatment of oral imatinib 400 mg daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 3.

Interventions: intervention 1: Imatinib intervention 2: Sildenafil intervention 3: Bosentan
Intervention descriptions: intervention 1: Film coated tablets, oral administration intervention 2: Oral Administration intervention 3: Oral Administration

Protocol document: