Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment
Completed · Phase 1
Conditions studied: Hepatic Impairment
In brief
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.
Key facts
- Study ID
- NCT01762462
- Run by
- Bristol-Myers Squibb
- People needed
- 17
- Starts
- 2012-12-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2025-03-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Investigational Site Number 840003 — Miami, Florida, United States
- Investigational Site Number 840002 — Orlando, Florida, United States
- Investigational Site Number 840001 — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
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