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

Completed · Phase 1

Conditions studied: Hepatic Insufficiency

In brief

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.

Key facts

Study ID

NCT01860326

Run by

Debiopharm International SA

People needed

32

Starts

2011-03-01

Expected to finish

2011-09-01

Last updated by the study team

2016-04-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Use of other investigational drugs
• Women of child-bearing potential
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• University of Miami — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.