Bioavailability of Apixaban Crushed Tablet

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Thrombosis

Treatments: Drug: Apixaban

Study type: Interventional

Funder types: Industry

Identifiers

NCT02101112

CV185-292

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 <lower limit of normal (LLN)
  • Hematocrit <LLN

Trial design

69 participants in 3 patient groups

Apixaban, 10 mg (whole tablets)

Experimental group

Description:

Participants received a single dose of apixaban, 10 mg, given orally as 2 5-mg whole commercial tablets (reference)

Treatment:

Drug: Apixaban

Apixaban, 10 mg (crushed and suspended in water)

Experimental group

Description:

Participants received a single dose of apixaban, 10 mg, given by mouth as 2 5-mg whole commercial tablets crushed and suspended in 30 mL of water

Treatment:

Drug: Apixaban

Apixaban, 10 mg (crushed and mixed with applesauce)

Experimental group

Description:

Participants received a single dose of 10 mg, given by mouth as 2 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce

Treatment:

Drug: Apixaban