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

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

OTAMIXABAN (XRP0673)

About this trial

This is an interventional basic science trial for Renal Impairment

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

Subject with renal impairment:
- Mild, moderate or severe renal impairment defined as Creatinine Clearance (CrCl) from 50 to 80, 30 to 50 and < 30 mL/min respectively, based on the Cockcroft-Gault formula,
- Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 95.0 kg inclusive if female, Body Mass Index between 18.0 and 34.9 kg/m2 inclusive.
- Stable chronic renal impairment as defined by Cockcroft-Gault formula,
- Vital signs, cardiac function and laboratory parameters within the acceptable range.
Or matched subject (by age, gender and body weight) with normal renal function (defined as CrCl >80 mL/min) and certified as healthy by physical examination, medical history and laboratory findings.
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, gastro-intestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness.
Active hepatitis, hepatic insufficiency.
Acute renal failure, nephrotic syndrome.
History of or current hematuria of urologic origin.
Subject requiring dialysis during the study.
History or presence of drug or alcohol abuse within two years before inclusion.
Smoking more than 15 cigarettes or equivalent per day.
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 840005
Investigational Site Number 840004
Investigational Site Number 840002

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Severe renal impairment population

Moderate renal impairment population

Mild renal impairment population

Healthy population

Arm Description

Healthy matched subjects

Outcomes

Primary Outcome Measures

Pharmacokinetics of Otamixaban (Observed concentration at the end of the infusion (Ceoi) and Areas Under the plasma concentration Curve(AUClast and AUC))

Secondary Outcome Measures

Pharmacodynamic effect based on coagulation parameters (activated Partial Prothrombin Time (aPTT), Prothrombin Time (PT) and International Normalized Ratio (INR))

Full Information

NCT ID

NCT01120314

First Posted

May 6, 2010

Last Updated

May 9, 2014

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01120314

Brief Title

Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal 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, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 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, moderate and severe renal impairment on the pharmacokinetics of Otamixaban. Secondary Objective: To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.

Detailed Description

The study period for one subject is broken down as follows: 2 to 28 days of screening, 1 day of treatment, 8 to 11 days of follow-up after start of infusion. There are 5 days in the unit starting the day before the start of infusion.

6. Conditions and Keywords

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

Renal Impairment

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Severe renal impairment population

Arm Type

Experimental

Arm Title

Moderate renal impairment population

Arm Type

Experimental

Arm Title

Mild renal impairment population

Arm Type

Experimental

Arm Title

Healthy population

Arm Type

Experimental

Arm Description

Healthy matched subjects

Intervention Type

Drug

Intervention Name(s)

OTAMIXABAN (XRP0673)

Intervention Description

Form: solution for injection Route: intravenous

Primary Outcome Measure Information:

Title

Pharmacokinetics of Otamixaban (Observed concentration at the end of the infusion (Ceoi) and Areas Under the plasma concentration Curve(AUClast and AUC))

Time Frame

4 days

Secondary Outcome Measure Information:

Title

Pharmacodynamic effect based on coagulation parameters (activated Partial Prothrombin Time (aPTT), Prothrombin Time (PT) and International Normalized Ratio (INR))

Time Frame

4 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Subject with renal impairment: Mild, moderate or severe renal impairment defined as Creatinine Clearance (CrCl) from 50 to 80, 30 to 50 and < 30 mL/min respectively, based on the Cockcroft-Gault formula, Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 95.0 kg inclusive if female, Body Mass Index between 18.0 and 34.9 kg/m2 inclusive. Stable chronic renal impairment as defined by Cockcroft-Gault formula, Vital signs, cardiac function and laboratory parameters within the acceptable range. Or matched subject (by age, gender and body weight) with normal renal function (defined as CrCl >80 mL/min) and certified as healthy by physical examination, medical history and laboratory findings. 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, gastro-intestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness. Active hepatitis, hepatic insufficiency. Acute renal failure, nephrotic syndrome. History of or current hematuria of urologic origin. Subject requiring dialysis during the study. History or presence of drug or alcohol abuse within two years before inclusion. Smoking more than 15 cigarettes or equivalent per day. 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 840005

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Investigational Site Number 840004

City

St. Paul

State/Province

Minnesota

ZIP/Postal Code

55144

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, Moderate and Severe Renal Impairment

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