Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD) BIA 9-1067 Opicapone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 74
Healthy volunteers: yes

Brief summary:
The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in steady-state conditions on the levodopa pharmacokinetics of a single dose of immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release levodopa/benserazide 100/25 mg.

Detailed description:
A single-centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of 18 healthy subjects each. This study consisted of a once-daily administration of BIA 9 1067 (5 mg, 15 mg or 50 mg) or placebo for 18 days. Twelve (12) hours after the BIA 9 1067 dose, a single-dose of levodopa/carbidopa 100/25 mg was administered on Day 11 and a single-dose of levodopa/benserazide 100/25 mg was administered on Day 18.

Arms:
arm 1: 1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. arm 2: 3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. arm 3: 2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. arm 4: 3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.

Interventions: intervention 1: BIA 9-1067 5 mg intervention 2: BIA 9-1067 25 mg intervention 3: levodopa/carbidopa 100/25 intervention 4: Placebo intervention 5: levodopa/benserazide 100/25 mg
Intervention descriptions: intervention 1: OPC, Opicapone intervention 2: OPC, Opicapone intervention 3: immediate (standard) release levodopa/carbidopa 100/25 intervention 4: PLC, Placebo intervention 5: immediate (standard) release levodopa/benserazide

Protocol document: