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

Use our guide to learn which trials are right for you!

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.
We found this trial at
3
sites
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials