Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal Impairment
- Registration Number
- NCT01120314
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate renal impairment population OTAMIXABAN (XRP0673) - Mild renal impairment population OTAMIXABAN (XRP0673) - Healthy population OTAMIXABAN (XRP0673) Healthy matched subjects Severe renal impairment population OTAMIXABAN (XRP0673) -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Pharmacodynamic effect based on coagulation parameters (activated Partial Prothrombin Time (aPTT), Prothrombin Time (PT) and International Normalized Ratio (INR)) 4 days
Trial Locations
- Locations (4)
Investigational Site Number 840003
🇺🇸Miami Gardens, Florida, United States
Investigational Site Number 840004
🇺🇸St. Paul, Minnesota, United States
Investigational Site Number 840005
🇺🇸Orlando, Florida, United States
Investigational Site Number 840002
🇺🇸Knoxville, Tennessee, United States