Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD) BIA 9-1067 Opicapone
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: yes

Brief summary:
The purpose of this study is to investigate CYP2C9 inhibition by BIA 9-1067 through the assessment of its effect on the pharmacokinetics of S-warfarin, a substrate of CYP2C9.

Detailed description:
Single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers. The study was to consist of 2 treatment periods separated by a washout period of 14 days or more. In one period, subjects were to receive a single-dose of 25 mg BIA 9-1067 with a single-dose of racemic 25 mg warfarin. In the other period, a 25 mg warfarin single-dose was to be administered alone.

Arms:
arm 1: Period 1: BIA 9-1067 + warfarin Period 2: warfarin arm 2: Period 1: warfarin Period 2: BIA 9-1067 + warfarin

Interventions: intervention 1: BIA 9-1067 intervention 2: Warfarin
Intervention descriptions: intervention 1: BIA 9-1067 25 mg intervention 2: Warfarin 25 mg

Protocol document: