Overview

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.