Conditions: Parkinson's Disease
Keywords: BIA 9-1067 Opicapone catechol-O-methyltransferase (COMT)
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 16
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess the pharmacokinetics (PK) of BIA 9-1067 in patients with moderate chronic hepatic impairment and in matched healthy subjects.

Detailed description:
This was an open-label, single-dose, parallel-group, in-patient, nonrandomized study conducted in 8 patients with moderate chronic hepatic impairment and in 8 healthy matched subjects matched by origin, age, sex, weight, and smoking habits.

Each hepatic impaired patient and matched healthy subject participated in the study for approximately one month, including a 21-day screening period and a 4-day/4-night inpatient period. The inpatient period covered the period from Day -1 to Day 4 morning (through 72 hours after administration). The final study evaluation was performed for all subjects in the morning of the day of discharge, Day 4.

Arms:
arm 1: Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067 arm 2: Group 2 - healthy subjects treated with BIA 9-1067

Interventions: intervention 1: BIA 9-1067
Intervention descriptions: intervention 1: Opicapone, OPC

Protocol document: