Effect of Venglustat in Patients With Renal Impairment

Exclusion Criteria

• •Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month)
• •Blood donation, any volume, within 2 months before inclusion
• •Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension judged clinically relevant by the Investigator
• •Any significant change in chronic treatment medication within 14 days before inclusion
• •Any drug which could impact by any mechanism of action, the pharmacokinetics of the investigational medicinal product, including moderate and strong cytochrome P3A (CYP3A) inhibitors or inducers; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion
• •Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab)
• •Positive result on urine drug screen or plasma alcohol test
• •Active hepatitis, hepatic insufficiency
• •If female, pregnancy \[defined as positive β-Human Chorionic Gonadotropin (β-HCG) blood test\], breast-feeding
• •Specific for subjects with renal impairment:
• •Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness
• •Acute renal failure (de novo or superimposed on 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
• •Specific for matched healthy controls:
• •\- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.