Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

Study Overview
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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.

Detailed Description
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Study duration=17-35 days

Official Title
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An Open-label, Pharmacokinetic and Tolerability Study of SAR302503 Given as a Single 300 mg Dose in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function

Conditions
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Hepatic Impairment

Intervention / Treatment
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* Drug: SAR302503


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR302503<br>single treatment with oral dose up to 300 mg of SAR302503 | Drug: SAR302503<br>* Pharmaceutical form:capsule Route of administration: oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter: Cmax, AUClast and AUC |  | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred |  | 12 days | 
| Safety parameters including Clinical tests |  | 16 days | 
| Safety parameters including laboratory tests |  | 16 days | 
| Safety parameters including ECG parameters |  | 16 days | 
| Number of subjects with adverse events (AEs) - Time Frame: |  | 16 days |