Renal Impairment
Conditions
Brief 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.
Detailed description
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.
Interventions
Form: solution for injection Route: intravenous
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of Otamixaban (Observed concentration at the end of the infusion (Ceoi) and Areas Under the plasma concentration Curve(AUClast and AUC)) | 4 days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic effect based on coagulation parameters (activated Partial Prothrombin Time (aPTT), Prothrombin Time (PT) and International Normalized Ratio (INR)) | 4 days |
Countries
United States
Outcome results
None listed