Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

End Stage Renal Disease

Treatments

Drug: Apixaban

Study type

Interventional

Funder types

Industry

Identifiers

NCT01340586

CV185-087

Details and patient eligibility

About

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.

Full description

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 .

Enrollment

18 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.