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

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.

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.

Exclusion criteria

• Uncontrolled clinically relevant cardiovascular, pulmonary, gastro-intestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness.
• Active hepatitis, hepatic insufficiency.
• Acute renal failure, nephrotic syndrome.
• History of or current hematuria of urologic origin.
• Subject requiring dialysis during the study.
• History or presence of drug or alcohol abuse within two years before inclusion.
• Smoking more than 15 cigarettes or equivalent per day.
• Any significant change in chronic treatment medication within 14-days before inclusion.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.