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

Debiopharm

Status and phase: Completed; Phase 1

Conditions: Hepatic Insufficiency

Treatments: Drug: Alisporivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01860326

CDEB025A2114

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

32 participants in 1 patient group

Alisporivir

Experimental group

Description:

Single 200 mg oral dose

Treatment:

Drug: Alisporivir