Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of single oral doses of Alisporivir in subjects with mild and moderate hepatic impairment compared to matched healthy subjects with normal liver function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Debiopharm International SA

Criteria

Inclusion criteria:

• Male or female, 18 to 70 years of age, in good health

• Stable Child-Turcotte-Pugh score of at least 5

• Body weight of at least 50 kg and a BMI of 18.0 to 36.0 kg/m2

Exclusion criteria:

• Use of other investigational drugs

• Women of child-bearing potential

Other protocol-defined inclusion/exclusion criteria may apply