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)
Sponsored by
About this trial
This is an interventional basic science trial for Renal Impairment
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.
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
Experimental
Experimental
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
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
No
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
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
Learn more about this trial
Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal Impairment
We'll reach out to this number within 24 hrs