NCT02101190

Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment

Open-label, Single-dose, Multi-center Study, Investigating the Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	BIA 9-1067	Opicapone, OPC

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2014-04-02
• Last updated: 2015-01-15
• Results posted: 2015-01-15

Locations

3 sites across 2 countries: France, Russia