Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor

32 subjects stratified by measured creatinine clearance into healthy controls (≥80 ml/min), mild (50-79 ml/min), moderate (30-49 ml/min), and severe renal impairment (<30 ml/min).

Rivaroxaban 10 mg oral single dose

Healthy controls with creatinine clearance ≥80 ml/min

Pharmacokinetics (plasma concentrations, AUC), pharmacodynamics (prothrombin time prolongation, Factor Xa inhibition), and safetysurrogate