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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
48
Form: solution for injection Route: intravenous
Investigational Site Number 840003
Miami Gardens, Florida, United States
Investigational Site Number 840005
Orlando, Florida, United States
Investigational Site Number 840004
Saint Paul, Minnesota, United States
Investigational Site Number 840002
Knoxville, Tennessee, United States
Pharmacokinetics of Otamixaban (Observed concentration at the end of the infusion (Ceoi) and Areas Under the plasma concentration Curve(AUClast and AUC))
Time frame: 4 days
Pharmacodynamic effect based on coagulation parameters (activated Partial Prothrombin Time (aPTT), Prothrombin Time (PT) and International Normalized Ratio (INR))
Time frame: 4 days
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