Conditions: Parkinson Disease
Keywords: BIA 9-1067
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 64
Healthy volunteers: yes

Brief summary:
The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses.

Detailed description:
Single centre, randomised, double-blind, placebo-controlled study of single ascending doses in up to 8 sequential groups of 8 healthy young male subjects.

Arms:
arm 1: BIA 9-1067 (Opicapone, OPC) - 10 mg arm 2: BIA 9-1067 (Opicapone, OPC) - 25 mg arm 3: BIA 9-1067 (Opicapone, OPC) - 50 mg arm 4: BIA 9-1067 (Opicapone, OPC) - 100 mg arm 5: BIA 9-1067 (Opicapone, OPC) - 200 mg arm 6: BIA 9-1067 (Opicapone, OPC) - 400 mg arm 7: BIA 9-1067 (Opicapone, OPC) - 800 mg arm 8: BIA 9-1067 (Opicapone, OPC) - 1200 mg arm 9: Placebo (PLC): single-dose

Interventions: intervention 1: BIA 9-1067 intervention 2: Placebo
Intervention descriptions: intervention 1: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects intervention 2: single-dose

Protocol document: