Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

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

Secondary Objective:

• To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Otamixaban

Criteria

Inclusion criteria:

• 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

• Patients with hepatic impairment will be matched to healthy subjects who are defined as healthy by physical examination, medical history and laboratory findings and are matched to patients with respect to age, gender, and body weight. Inclusion/exclusion criteria for healthy subjects may differ slightly from those listed for patients and are defined in the study protocol

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

• 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.