Bioavailability of Apixaban Crushed Tablet

Bristol-Myers Squibb69 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Thrombosis

Interventions

ApixabanDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban

Maximum observed plasma concentration (Cmax) measured in nanograms per milliliter (ng/mL)

Time frame: Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 and 72 hours post dose

Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban

Area Under the Plasma Concentration-time Curve (AUC) From Time of Zero Extrapolated to Infinite Time (INF) \[AUC (INF)\] is measured as nanograms multiplied by hours per milliliter (ng\*h/mL)

Time frame: Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose

Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban

Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Concentration \[AUC (0-T)\] is measured as nanograms multiplied by hours per milliliter (ng\*h/mL)

Time frame: Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose

Secondary Outcomes

Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion

Adverse Event (AE) = any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious Adverse Event (SAE)= a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

Time frame: Randomization to May 2014; approximately 6 weeks

Data from ClinicalTrials.gov

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