Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
The duration of each part of the study for one subject was 28 days of screening, 1 day of treatment, with 5 days in the unit (Day -1 to Day 4) and a 8 to 11 days of follow-up after start of infusion.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\- Subjects with hepatic impairment:
Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 100.0 kg inclusive if female, Body Mass Index between 18.0 and 34.9 kg/m2 inclusive
Stable chronic liver disease assessed by medical history, physical examination, laboratory values
Vital signs, cardiac function and laboratory parameters within the acceptable range for subjects with hepatic impairment
If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal
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
Creatinine level above the upper limit of normal
Hepatocarcinoma
Acute hepatitis
Hepatic encephalopathy grade 2, 3 and 4
History or presence of drug or alcohol abuse within two years before inclusion
Smoking more than 15 cigarettes or equivalent per day, unable to refrain from smoking during the institutionalization
Any significant change in chronic treatment medication within 14 days before inclusion
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Clareo Health | Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment
