Bioavailability of Apixaban Crushed Tablet

This study will investigate the bioavailability of apixaban administered as crushed tablets suspended in water and as crushed tablets mixed with applesauce compared with that of whole tablets. The study results may allow enhancement of the apixaban label to include alternative methods of apixaban administration, which may be of benefit to patients who have difficulty swallowing.

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 <lower limit of normal (LLN)
• Hematocrit <LLN