Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD) Opicapone Bial BIA 9-1067
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 34
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising dose regimens of BIA 9-1067.

Detailed description:
Single centre, double-blind, randomised, placebo-controlled study of four dosage regimens of BIA 9-1067 in four groups of healthy male volunteers. In each group, the study will consist of an once-daily (o.d.) 8-day multiple-dose period. Progression to the next dose level will only occur if the previous dose level was considered to be safe and well tolerated. An appropriate interval (will separate the investigation of doses to permit a timely review and evaluation of safety data prior to proceeding to a higher dose level.

Arms:
arm 1: BIA 9-1067 (OPC, Opicapone) 5 mg arm 2: BIA 9-1067 (OPC, Opicapone) 10 mg arm 3: BIA 9-1067 (OPC, Opicapone) 20 mg arm 4: BIA 9-1067 (OPC, Opicapone) 30 mg arm 5: Placebo, PLC

Interventions: intervention 1: BIA 9-1067 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: