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

Status:	Completed
Conditions:	Gastrointestinal, Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 70
Updated:	4/29/2016
Start Date:	March 2011
End Date:	September 2011

An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Oral Doses of DEB025 in Subjects With Mild and Moderate Hepatic Impairment Compared to Matched Healthy Subjects With Normal Liver Function

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.

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

We found this trial at

sites

University of Miami

Miami, Florida 33124

(305) 284-2211