drugset / Trial / NCT01120314

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

NCT01120314

Phase 1 Completed 48 enrolled Sanofi
Non-randomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2010-04
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Otamixaban Small molecule 100 ug/kg Intravenous