Phase 1
N=33
Bioavailability of Apixaban Crushed Tablet
Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT02101112 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban — 236; 249; 186 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Apixaban (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban |
236; 249; 186 | — |
| PRIMARY Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban |
2461; 2528; 2055 | — |
| PRIMARY 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 |
2423; 2488; 2015 | — |
| SECONDARY Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban |
2.00; 2.00; 2.00 | — |
| SECONDARY Terminal Plasma Half-life (T-HALF) of Apixaban |
12.4; 12.2; 12.5 | — |
| SECONDARY Relative Bioavailability (Frel) of Apixaban |
1.03; 0.836 | — |
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.
Eligibility Criteria
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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 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
Data sourced from ClinicalTrials.gov (NCT02101112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.