Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment

Parkinson's Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

• NCT number: NCT02101190
• Study type: Interventional
• Source: Bial - Portela C S.A.
• Status: Completed
• Phase: Phase 1
• Start date: March 2010
• Completion date: May 2010