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

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.