Pharmacokinetic and Tolerability Study of 14 mg Single Dose of Teriflunomide in Subjects With Severe Renal Impairment

Inclusion criteria: Subjects with renal impairment: * Male subject between 18 and 75 years of age inclusive and postmenopausal female between 45 and 75 years of age inclusive. * Chronic severe renal impairment as defined by Cockroft-Gault formula (creatinine clearance (CLcr) \< 30mL/min, but not requiring hemodialysis). * Laboratory parameters within the acceptable range for subjects with renal impairment; in particular, hepatic enzymes (ALT, AST) and bilirubin should be \< 2 x upper limit of normal range and neutrophils should be within normal ranges. Matched healthy subjects: * Male subject between 18 and 75 years of age inclusive and postmenopausal female between 45 and 75 years of age inclusive, matched by age. * Body weight within 15% of the body weight of the subjects with renal impairment to be matched and Body Mass Index between 18.0 and 30.0 mg/kg2 inclusive. * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). * Normal renal function as defined by Cockroft-Gault formula (creatinine clearance (CLcr) \> 80mL/min) * Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; however serum creatinine, alkaline phosphatase, hepatic enzymes (AST, ALT), bilirubin (unless the subject has documented Gilbert syndrome) should not exceed the upper limit of normal range. Exclusion criteria: Subjects with renal impairment: * Uncontrolled clinically relevant cardiovascular, pulmonary, gastro-intestinal, 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 pre-existing chronic renal impairment), nephrotic syndrome. * Subject requiring dialysis during the study. * Any significant change in chronic treatment medication within 14-days before inclusion. * Any drug, which could impact by any mechanism of action, the pharmacokinetic of the investigational product. * Positive reaction to Human Immunodeficiency Virus (HIV) tests: anti-HIV1 antibodies, anti-HIV2 antibodies * Positive results on urine drug screen (amphetamines / methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates) unless this result is secondary to a documented medical prescription. * Positive alcohol test. * Man who disagrees to use a double barrier method of contraception with their partner during the study. Matched healthy subjects: * Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. * For subjects 50 years old and below: * any medication (including St John's Wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic halflife of that drug, whichever the longest, with the exception of menopausal hormone replacement therapy. * any significant change in chronic treatment medication within 14-days before inclusion. * Any drug, which could impact by any mechanism of action, the pharmacokinetic of the investigational product. * Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, antihepatitis C virus (anti-HCV) antibodies, HIV1 antibodies, anti-HIV2 antibodies. * Positive results on urine drug screen (amphetamines / methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). * Positive alcohol test. * Man who disagrees to use a double barrier method of contraception with their partner during the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.