Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis

Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Apixaban in Subjects on Hemodialysis

The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg Apixaban in subjects with normal renal function and subjects with end stage renal disease (ESRD) maintained with hemodialysis.

Primary Purpose : To provide a clear understanding of the pharmacokinetics of Apixaban in subjects with ESRD and to determine the effect of hemodialysis on Apixaban pharmacokinetics .

Inclusion Criteria:

• The signed informed consent form.
• Subjects with normal renal function classified based on calculated creatinine clearance (CLCr) determined by the cockcroft-gault calculation.
• Eligible subjects with ESRD that is maintained with chronic and stable hemodialysis.

Exclusion Criteria:

• Any history of abnormal bleeding or coagulation disorders including those in a first degree relative under 50 years of age.
• History of significant head injury within the last two years.
• Any gastrointestinal surgery that could impact the absorption of study drug.
• Not expected to continue the hemodialysis treatment for the duration of the study.
• INR, PT, or aPTT above the upper limit of normal, unless agreed upon between the investigator and BMS medical monitor.
• History of allergy to Apixaban or Factor Xa inhibitors.