Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

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.

Key facts

Study ID

NCT01763190

Run by

Bristol-Myers Squibb

People needed

36

Starts

2012-11-01

Expected to finish

2013-07-01

Last updated by the study team

2025-03-05

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840002 — Orlando, Florida, United States
• Investigational Site Number 840003 — Saint Paul, Minnesota, United States
• Investigational Site Number 840001 — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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