Conditions: Parkinson Disease
Keywords: Parkinson Disease BIA 9-1067
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 82
Healthy volunteers: yes

Brief summary:
To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.

Detailed description:
Single-centre, double-blind, randomised, parallel-group study in 80 young male and female healthy subjects.

Arms:
arm 1: Placebo at all the dosing times arm 2: Day 1 to 7:

BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose arm 3: Day 1 to 7:

BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose arm 4: Day 1 to 7:

BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose arm 5: Day 1 to 7:

Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose

Day 8:

Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose

Interventions: intervention 1: BIA 9-1067 5 mg intervention 2: Entacapone intervention 3: Placebo intervention 4: levodopa/carbidopa intervention 5: BIA 9-1067 15 mg intervention 6: BIA 9-1067 30 mg
Intervention descriptions: intervention 1: BIA 9-1067 OPC, Opicapone 5 mg intervention 2: Entacapone 200 mg intervention 3: placebo (four times a day) intervention 4: standard release levodopa/carbidopa 100/25 mg (single-dose) intervention 5: BIA 9-1067 OPC, Opicapone 15 mg intervention 6: BIA 9-1067 OPC, Opicapone 30 mg

Protocol document: