drugset / Trial / NCT01860326

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

NCT01860326

Phase 1 Completed 32 enrolled Debiopharm International SA
NaSingle-groupOpen-label

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.

Timeline

Start
2011-03
Primary completion
2011-09
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Alisporivir Protein / enzyme biologic 200 mg Oral

Indications