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

Primary Purpose

Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

otamixaban XRP0673

About this trial

This is an interventional treatment trial for Hepatic Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Investigational Site Number 840003
Investigational Site Number 840001
Investigational Site Number 840002

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Mild impairment

Moderate impairment

Healthy subjects

Arm Description

Patients with mild hepatic impairment

Patients with moderate impairment

Matched healthy subjects

Outcomes

Primary Outcome Measures

PK parameters including Ceoi, AUClast, AUC, C1min, CL, Vss, and t1/2z

Pharmacodynamic based on coagulation parameters, activated partial prothrombin time (aPTT), prothrombin time (PT), and international normalized ratio (INR)

Secondary Outcome Measures

Safety based on treatment-emergent adverse events, clinical laboratory evaluations, vital signs, and ECG

Full Information

NCT ID

NCT01126086

First Posted

May 17, 2010

Last Updated

May 7, 2014

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01126086

Brief Title

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

Official Title

An Open-label Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban Given as a Single 80 μg/kg Bolus Plus 100 μg/kg/h Continuous Infusion for 24 Hours in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mild impairment

Arm Type

Experimental

Arm Description

Patients with mild hepatic impairment

Arm Title

Moderate impairment

Arm Type

Experimental

Arm Description

Patients with moderate impairment

Arm Title

Healthy subjects

Arm Type

Experimental

Arm Description

Matched healthy subjects

Intervention Type

Drug

Intervention Name(s)

otamixaban XRP0673

Intervention Description

Pharmaceutical form: solution for injection Route of administration: intravenous

Primary Outcome Measure Information:

Title

PK parameters including Ceoi, AUClast, AUC, C1min, CL, Vss, and t1/2z

Time Frame

Day 1 to Day 4

Title

Pharmacodynamic based on coagulation parameters, activated partial prothrombin time (aPTT), prothrombin time (PT), and international normalized ratio (INR)

Time Frame

Screening (-28 days) up to 4 days after treatment

Secondary Outcome Measure Information:

Title

Safety based on treatment-emergent adverse events, clinical laboratory evaluations, vital signs, and ECG

Time Frame

Screening (-28 days) up 8 to 11 days after treament

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 840003

City

Miami Gardens

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

Investigational Site Number 840001

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

Investigational Site Number 840002

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

12. IPD Sharing Statement

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

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