Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Apixaban

Criteria

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.