Overview

Bioavailability of Apixaban Crushed Tablet

Status:
Completed

Trial end date:
2014-05-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to determine whether the bioavailability of apixaban crushed tablets suspended in water or mixed with applesauce is similar to the bioavailability of apixaban whole tablets administered orally.

Phase:

Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Bristol-Myers Squibb

Treatments:

Apixaban

Criteria

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Healthy participants as determined by no clinically significant deviation from normal
in findings of medical history, physical examination, electrocardiograms, vital signs,
and clinical laboratory tests.

- Women of childbearing potential allowed. Must be following highly effective methods of
contraception

Exclusion Criteria:

- Any significant acute or chronic medical illness

- History of significant head injury within the last 2 years, including individuals with
base of skull fractures

- Any major surgery within 4 weeks of study drug administration or anticipated within 2
weeks after completion of the study

- Any gastrointestinal (GI) surgery or GI disease that could impact absorption of study
drug

- History of Gilbert's Syndrome

- Inability to tolerate oral medication

- Inability to be venipunctured and/or tolerate venous access

- Use of tobacco- or nicotine-containing products (including, but not limited to,
cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or
nicotine gum) within 6 months prior to study drug administration

- Any laboratory test results outside of the range of normal, confirmed by repeat
results of:

- Platelet count <150,000 cells/µL

- Activated partial thromboplastin time >upper limit of normal (ULN)

- International normalized ratio >ULN

- Alanine aminotransferase >ULN

- Aspartate aminotransferase >ULN

- Total bilirubin >ULN

- Serum creatinine ≥1.5 mg/dL

- Hemoglobin
- Hematocrit