Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment (NCT01763190) | Clinical Trial Compass
CompletedPhase 1
Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment
United States36 participantsStarted 2012-11
Plain-language 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.
Who can participate
Age range18 Years – 79 Years
SexALL
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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 a…