Renal Impairment
Conditions
Brief summary
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
study duration = 17 to 35 days
Interventions
DRUGSAR302503
Pharmaceutical form:capsule Route of administration: oral
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameter: Cmax, AUClast and AUC | 12 days |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed