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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Alisporivir

Single 200 mg oral dose

Group Type EXPERIMENTAL

Alisporivir

Intervention Type DRUG

Capsules supplied as open labeled bulk medication in 10-unit blister packages

Interventions

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Alisporivir

Capsules supplied as open labeled bulk medication in 10-unit blister packages

Intervention Type DRUG

Other Intervention Names

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DEB025

Eligibility Criteria

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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