NCT01860326

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Insufficiency

Interventions

Type	Name	Description
DRUG	Alisporivir	Capsules supplied as open labeled bulk medication in 10-unit blister packages

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2013-05-22
• Last updated: 2016-04-28

Locations

2 sites across 1 country: United States