Lead Sponsor

Bristol-Myers Squibb

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

No

•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.

•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.

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