Clinical Trials/NCT01120314

NCT01120314

Completed

Phase 1

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

Sanofi4 sites in 1 country48 target enrollmentApril 2010

ConditionsRenal Impairment

InterventionsOTAMIXABAN (XRP0673)

Overview

Phase: Phase 1
Intervention: OTAMIXABAN (XRP0673)
Conditions: Renal Impairment
Sponsor: Sanofi
Enrollment: 48
Locations: 4
Primary Endpoint: Pharmacokinetics of Otamixaban (Observed concentration at the end of the infusion (Ceoi) and Areas Under the plasma concentration Curve(AUClast and AUC))
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

July 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Severe renal impairment population

Intervention: OTAMIXABAN (XRP0673)

Moderate renal impairment population

Intervention: OTAMIXABAN (XRP0673)

Mild renal impairment population

Intervention: OTAMIXABAN (XRP0673)

Healthy population

Healthy matched subjects

Intervention: OTAMIXABAN (XRP0673)

Outcomes

Primary Outcomes

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 Outcomes

Pharmacodynamic effect based on coagulation parameters (activated Partial Prothrombin Time (aPTT), Prothrombin Time (PT) and International Normalized Ratio (INR))(4 days)