Bioavailability of Apixaban Crushed Tablet

Overview[ - collapse ][ - ]

Purpose The purpose of this study is to determine if the bioavailability of Apixaban crushed tablets suspended in water or mixed with applesauce is similar to the bioavailability of Apixaban whole tablets administered orally.
ConditionThrombosis
InterventionDrug: Apixaban
PhasePhase 1
SponsorBristol-Myers Squibb
Responsible PartyBristol-Myers Squibb
ClinicalTrials.gov IdentifierNCT02101112
First ReceivedMarch 28, 2014
Last UpdatedMarch 28, 2014
Last verifiedMarch 2014

Tracking Information[ + expand ][ + ]

First Received DateMarch 28, 2014
Last Updated DateMarch 28, 2014
Start DateMarch 2014
Estimated Primary Completion DateMay 2014
Current Primary Outcome Measures
  • Maximum observed plasma concentration (Cmax) of Apixaban [Time Frame: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose] [Designated as safety issue: No]
  • Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Apixaban [Time Frame: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose] [Designated as safety issue: No]
  • Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Apixaban [Time Frame: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Safety and tolerability of Apixaban measured by incidence of AEs, SAEs, and AEs leading to discontinuation; and results of vital signs, ECGs, physical examinations, and clinical laboratory tests [Time Frame: Days 1-12 inclusive] [Designated as safety issue: Yes]AE = Adverse Event
    SAE = Serious Adverse Event
  • Cmax of Apixaban [Time Frame: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose] [Designated as safety issue: No]
  • AUC(INF) of Apixaban [Time Frame: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose] [Designated as safety issue: No]
  • AUC(0-T) of Apixaban [Time Frame: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose] [Designated as safety issue: No]
  • Time of maximum observed plasma concentration (Tmax) of Apixaban [Time Frame: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose] [Designated as safety issue: No]
  • Terminal plasma half-life (T-HALF) of Apixaban [Time Frame: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose] [Designated as safety issue: No]
  • Relative bioavailability (Frel) of Apixaban [Time Frame: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleBioavailability of Apixaban Crushed Tablet
Official TitleRelative Bioavailability of Crushed Apixaban Tablets Administered With Water or Apple Sauce Compared With Intact Tablet in Healthy Subjects
Brief Summary
The purpose of this study is to determine if the bioavailability of Apixaban crushed tablets
suspended in water or mixed with applesauce is similar to the bioavailability of Apixaban
whole tablets administered orally.
Detailed Description
Primary Purpose: Other: This study will investigate the bioavailability of Apixaban when
administered as crushed tablets suspended in water and as crushed tablets mixed with
applesauce compared to whole tablets. The results of this study may allow enhancement of the
Apixaban label to include alternative methods of administration of Apixaban tablet; this may
be of benefit to patients who have difficulty swallowing
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
ConditionThrombosis
InterventionDrug: Apixaban
Other Names:
Eliquis®
Study Arm (s)
  • Experimental: Arm A: Apixaban (Reference - whole tablet)
    Apixaban whole tablet by mouth once on specified days
  • Experimental: Arm B: Apixaban (crushed & suspended in water)
    Apixaban tablets (crushed and suspended in water) by mouth once on specified days
  • Experimental: Arm C: Apixaban (crushed and mixed with applesauce)
    Apixaban tablets (crushed and mixed with applesauce) by mouth once on specified days

Recruitment Information[ + expand ][ + ]

Recruitment StatusNot yet recruiting
Estimated Enrollment33
Estimated Completion DateMay 2014
Estimated Primary Completion DateMay 2014
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Healthy subjects as determined by no clinically significant deviation from normal in
medical history, physical examination, electrocardiograms (ECGs), vital signs, and
clinical laboratory determinations

- 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 subjects 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 of the following laboratory results outside of the ranges specified below prior
to study drug administration, confirmed by repeat:

- Platelet count <150,000 cells/µL

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

- International normalized ratio (INR) >ULN

- Alanine aminotransferase (ALT) >ULN

- Aspartate aminotransferase (AST) >ULN

- Total bilirubin >ULN

- Serum creatinine ≥1.5 mg/dL

- Hemoglobin
- Hematocrit
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT02101112
Other Study ID NumbersCV185-292
Has Data Monitoring CommitteeNo
Information Provided ByBristol-Myers Squibb
Study SponsorBristol-Myers Squibb
CollaboratorsNot Provided
Investigators Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Verification DateMarch 2014