Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Study duration=17-35 days
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment
