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 |
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.
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