NCT01120314

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	OTAMIXABAN (XRP0673)	Form: solution for injection Route: intravenous

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-05-10
• Last updated: 2014-05-12

Locations

4 sites across 1 country: United States