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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mild impairment

Patients with mild hepatic impairment

Group Type EXPERIMENTAL

otamixaban XRP0673

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: intravenous

Moderate impairment

Patients with moderate impairment

Group Type EXPERIMENTAL

otamixaban XRP0673

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: intravenous

Healthy subjects

Matched healthy subjects

Group Type EXPERIMENTAL

otamixaban XRP0673

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: intravenous

Interventions

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otamixaban XRP0673

Pharmaceutical form: solution for injection

Route of administration: intravenous

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No