Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-03-31

Brief Summary

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Primary Objective:

To study the effect of mild and moderate hepatic impairment on the pharmacokinetics of SAR302503.

Secondary Objective:

To assess the tolerability of SAR302503 given as a single dose up to 300 mg in subjects with mild and moderate and hepatic impairment and in matched subjects with normal hepatic function.

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Detailed Description

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Study duration=17-35 days

Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SAR302503

single treatment with oral dose up to 300 mg of SAR302503

Group Type EXPERIMENTAL

SAR302503

Intervention Type DRUG

Pharmaceutical form:capsule

Route of administration: oral

Interventions

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SAR302503

Pharmaceutical form:capsule

Route of administration: oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects, between 18 and 75 years of age, inclusive.
* Body weight between 50.0 and 115.0 kg, inclusive if male, and between 40.0 and 100.0 kg, inclusive if female, body mass index between 18.0 and 34.9 kg/m2, inclusive.
* Stable chronic liver disease with Child-Pugh classification score between 5 and 9 assessed by medical history, physical examination, laboratory values
* 12-lead ECG without clinically significant abnormality
* Laboratory parameters within the acceptable range for subjects with hepatic impairment
* Using a double contraception method

Exclusion Criteria

* Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
* Hepatocarcinoma.
* Acute hepatitis
* Any significant change in chronic treatment medication within 14 days before inclusion
* Concomitant treatment with or use of drugs or herbal agents known to be at least moderate inhibitors or inducers CYP3A4 sensitive or narrow therapeutic index substrate of CYP3A4
* Concomitant treatment gastric pH modifying agent
* Positive result on any of the following tests: anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
* Positive result on urine drug screen
* Positive alcohol test.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No