Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD) BIA 9-1067 Opicapone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: yes

Brief summary:
The purpose of this study is to determine the effect of repeated dosing of once-daily 25, 50 and 75 mg opicapone (OPC, development code BIA 9-1067) on the levodopa pharmacokinetics (PK), in comparison to placebo and 200 mg entacapone (ENT).

Detailed description:
This study was a single-centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of 20 healthy subjects each (10 male and 10 female). The clinical part included a screening examination within 3 weeks before the first institutionalization, an ambulatory period of 11 days (from Day 1 evening to Day 11 evening), during which the subjects returned to the clinical unit every evening, followed by an institutionalization of 1.5 days (from Day 11 evening to Day 13 morning (i.e. 14 h after the third administration of levodopa/carbidopa). Then, a follow-up visit at 5 to 9 days after collection of the last PK blood sample (i.e. Day 13). The maximum total duration of the clinical study, including the 21-day screening period and the post-study follow-up, was expected to be about 39 to 43 days.

Arms:
arm 1: Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12 arm 2: 25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12 arm 3: 50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12 arm 4: 75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12 arm 5: placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12

Interventions: intervention 1: BIA 9-1067 intervention 2: Entacapone intervention 3: Placebo intervention 4: Levodopa/carbidopa
Intervention descriptions: intervention 1: BIA 9-1067 25 mg and 50 mg intervention 2: Entacapone (ENT), over-encapsulated tablet 200 mg intervention 3: PLC, placebo intervention 4: Levodopa/carbidopa, tablet 100/25 mg

Protocol document: