Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - 79 |
Updated: | 10/3/2013 |
Start Date: | November 2012 |
End Date: | August 2013 |
Contact: | For site information, send an email with site number to |
Email: | Contact-Us@sanofi.com |
An Open-label Pharmacokinetic and Tolerability Study 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
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.
study duration = 17 to 35 days
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.
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