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

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120314
• Other study ID #: POP6537
• Secondary ID: U1111-1116-5821
• Status: Completed
• Phase: Phase 1
• First received: May 6, 2010
• Last updated: May 9, 2014
• Start date: April 2010
• Est. completion date: July 2011

Study information

• Verified date: May 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• OTAMIXABAN (XRP0673)
Form: solution for injection Route: intravenous

Locations

Country	Name	City	State
United States	Investigational Site Number 840002	Knoxville	Tennessee
United States	Investigational Site Number 840003	Miami Gardens	Florida
United States	Investigational Site Number 840005	Orlando	Florida
United States	Investigational Site Number 840004	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of Otamixaban (Observed concentration at the end of the infusion (Ceoi) and Areas Under the plasma concentration Curve(AUClast and AUC))		4 days	No
Secondary	Pharmacodynamic effect based on coagulation parameters (activated Partial Prothrombin Time (aPTT), Prothrombin Time (PT) and International Normalized Ratio (INR))		4 days	No