Phase 1 Bioavailability Study of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects | RxWiki

Phase 1 Bioavailability Study of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to assess the oral bioavailability of Apixaban solution formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban Phase 3 tablets (Treatment A, 10 mg as 2 x 5 mg tablets) in healthy subjects.
Condition	Healthy Volunteers
Intervention	Drug: Apixaban
Phase	Phase 1
Sponsor	Bristol-Myers Squibb
Responsible Party	Bristol-Myers Squibb
ClinicalTrials.gov Identifier	NCT02034565
First Received	January 10, 2014
Last Updated	January 10, 2014
Last verified	January 2014

Tracking Information[ + expand ][ + ]

First Received Date	January 10, 2014
Last Updated Date	January 10, 2014
Start Date	February 2010
Estimated Primary Completion Date	March 2010
Current Primary Outcome Measures	Bioavailability of Apixaban solution formulation relative to Apixaban Phase 3 tablets in healthy subjects [Time Frame: Up to 8 Days] [Designated as safety issue: No]
Current Secondary Outcome Measures	Maximum observed plasma concentration (Cmax) of Apixaban obtained from the plasma concentration versus time data [Time Frame: 32 timepoints up to Day 8] [Designated as safety issue: No] Time of maximum observed plasma concentration (Tmax) of Apixaban obtained from the plasma concentration versus time data [Time Frame: 32 timepoints up to Day 8] [Designated as safety issue: No] Area under the plasma concentration-time curve from time zero to the time of last quantifiable plasma concentration [AUC (0-T)] of Apixaban obtained from the plasma concentration versus time data [Time Frame: 32 timepoints up to Day 8] [Designated as safety issue: No] Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC (INF)] of Apixaban obtained from the plasma concentration versus time data [Time Frame: 32 timepoints up to Day 8] [Designated as safety issue: No] Plasma elimination half-life (T-Half) of Apixaban obtained from the plasma concentration versus time data [Time Frame: 32 timepoints up to Day 8] [Designated as safety issue: No] Safety analysis based on the Adverse events reports, Vital sign measurements, Electro cardiogram (ECG), physical examinations, and clinical laboratory tests [Time Frame: Up to Day 8] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Phase 1 Bioavailability Study of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects
Official Title	Study of Bioavailability of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects
Brief Summary	The purpose of this study is to assess the oral bioavailability of Apixaban solution formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban Phase 3 tablets (Treatment A, 10 mg as 2 x 5 mg tablets) in healthy subjects.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Condition	Healthy Volunteers
Intervention	Drug: Apixaban Other Names: BMS - 562247
Study Arm (s)	Experimental: Arm A: Apixaban tablet Apixaban Film coated Tablet Single dose 10 mg orally Experimental: Arm B: Apixaban oral solution Apixaban Solution Single dose 10 mg orally

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	14
Estimated Completion Date	March 2010
Estimated Primary Completion Date	March 2010
Eligibility Criteria	Inclusion Criteria: - Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Exclusion Criteria: - Any significant acute or chronic medical illness or relevant trauma (e.g., history of chronic hypertension, bacterial endocarditis, hemorrhagic stroke, motor vehicle accident resulting in significant head trauma or internal injuries) - History or evidence of abnormal bleeding or coagulation disorder (e.g., easy bruising or gingival bleeding, prolonged bleeding after dental extraction, postpartum, or after trauma, wounds or surgery)
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT02034565
Other Study ID Numbers	CV185-029
Has Data Monitoring Committee	No
Information Provided By	Bristol-Myers Squibb
Study Sponsor	Bristol-Myers Squibb
Collaborators	Pfizer
Investigators	Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Verification Date	January 2014

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