Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis

Completed · Phase 1

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT01340586

Run by

Bristol-Myers Squibb

People needed

18

Starts

2011-06-01

Expected to finish

2011-09-01

Last updated by the study team

2016-10-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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