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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Hepatic Insufficiency

Intervention / Treatment
-----------------
* Drug: Alisporivir


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alisporivir<br>Single 200 mg oral dose | Drug: Alisporivir<br>* Capsules supplied as open labeled bulk medication in 10-unit blister packages<br>* Other names: DEB025;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Concentration (Cmax) of alisporivir |  | 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose | 
| Area under the time-concentration curve (AUC) for alisporivir | Categories: AUC up to the last measurable concentration (AUClast) and AUC from time 0 to the last time point measured (AUC0-t) | 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to maximum concentration (Tmax) of alisporivir |  | 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose | 
| Half-Life (T1/2) of alisporivir |  | 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose | 
| Apparent total body clearance from plasma (CL/F) of alisporivir |  | 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose | 
| Apparent volume of distribution (Vz/F) of alisporivir |  | 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatic impairment, mild and moderate hepatic impairment, Alisporivir