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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: otamixaban XRP0673

Study type: Interventional

Funder types: Industry

Identifiers

NCT01126086

U1111-1116-8891 (Other Identifier)

POP6207

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Mild impairment

Experimental group

Description:

Patients with mild hepatic impairment

Treatment:

Drug: otamixaban XRP0673

Moderate impairment

Experimental group

Description:

Patients with moderate impairment

Treatment:

Drug: otamixaban XRP0673

Healthy subjects

Experimental group

Description:

Matched healthy subjects

Treatment:

Drug: otamixaban XRP0673