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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi
• Treatments: Otamixaban

Criteria

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.