Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

Study Overview
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Brief Summary
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Primary Objective: To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of SAR302503. Secondary Objective: To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.

Detailed Description
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study duration = 17 to 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, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function

Conditions
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Renal 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. For subjects between ages 75 to 79 with the approval from sponsor's medical monitor. 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 renal impairment, as defined by Cockcroft-Gault formula; Laboratory parameters within the acceptable range for subjects with renal 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 Active hepatitis, hepatic insufficiency Acute renal failure (de novo or superimposed to preexisting chronic renal impairment), nephrotic syndrome History of or current hematuria of urologic origin that limits the subject's participation in the study Subjects requiring dialysis during the study. 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 with gastric pH modifying agents (proton pump inhibitors and H2-blockers) is not allowed 7 days prior to and 6 hours after study drug treatment 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: 79 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 of 300 mg oral dose 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) |  | 16 days |