Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:11/30/-0001
Start Date:December 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 and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function


Primary Objective:

To study the effect of mild and moderate hepatic impairment on the pharmacokinetics of
SAR302503.

Secondary Objective:

To assess the tolerability of SAR302503 given as a single dose up to 300 mg in subjects with
mild and moderate and hepatic impairment and in matched subjects with normal hepatic
function.


Study duration=17-35 days

Inclusion criteria :

- Male or female subjects, between 18 and 75 years of age, inclusive.

- 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 liver disease with Child-Pugh classification score between 5 and 9
assessed by medical history, physical examination, laboratory values

- 12-lead ECG without clinically significant abnormality

- Laboratory parameters within the acceptable range for subjects with hepatic
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.

- Hepatocarcinoma.

- Acute hepatitis

- 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 gastric pH modifying agent

- Positive result on any of the following tests: anti-human immunodeficiency virus 1
and 2 antibodies (anti-HIV1 and anti HIV2 Ab).

- Positive result on urine drug screen

- Positive alcohol test.

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
2134
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
1923
mi
from 91732
Knoxville, TN
Click here to add this to my saved trials
2316
mi
from 91732
Miami Gardens, FL
Click here to add this to my saved trials