Phase 1 Oral Solution and Crushed Tablet Relative Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects | RxWiki

Phase 1 Oral Solution and Crushed Tablet Relative Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to assess the bioavailability of Apixaban oral solution administered through an Nasogastric Tube (NGT) in the presence of Boost® Plus and Apixaban administered as crushed tablet through a nasogastric tube relative to Apixaban solution administered orally in healthy subjects.
Condition	Healthy Subjects
Intervention	Drug: Apixaban
Phase	Phase 1
Sponsor	Bristol-Myers Squibb
Responsible Party	Bristol-Myers Squibb
ClinicalTrials.gov Identifier	NCT02034591
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	October 2011
Estimated Primary Completion Date	November 2011
Current Primary Outcome Measures	Bioavailability of Apixaban oral solution (OS) administered through NGT in the presence of Boost Plus® relative to Apixaban solution administered orally in healthy subjects [Time Frame: Up to Day 12] [Designated as safety issue: No]
Current Secondary Outcome Measures	Bioavailability of Apixaban crushed tablet administered through NGT relative to Apixaban solution administered orally in healthy subjects [Time Frame: Up to Day 12] [Designated as safety issue: No] Maximum observed plasma concentration (Cmax) of Apixaban will be derived from plasma concentration versus time [Time Frame: 48 timepoints up to Day 12] [Designated as safety issue: No] Time of maximum observed plasma concentration (Tmax) of Apixaban will be derived from plasma concentration versus time [Time Frame: 48 timepoints up to Day 12] [Designated as safety issue: No] Area under the plasma concentration-time curve from zero to the last time of last quantifiable concentration [AUC(0-T)] of Apixaban will be derived from plasma concentration versus time [Time Frame: 48 timepoints up to Day 12] [Designated as safety issue: No] Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Apixaban will be derived from plasma concentration versus time [Time Frame: 48 timepoints up to Day 12] [Designated as safety issue: No] Plasma elimination half-life (T-HALF) of Apixaban will be derived from plasma concentration versus time [Time Frame: 48 timepoints up to Day 12] [Designated as safety issue: No] Relative bioavailability as calculated by ratio of AUC(INF) (Frel) of Apixaban will be derived from plasma concentration versus time [Time Frame: 48 timepoints up to Day 12] [Designated as safety issue: No] Safety assessed by incidence of adverse events, results of vital sign measurements, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests [Time Frame: Up to Day 12] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Phase 1 Oral Solution and Crushed Tablet Relative Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects
Official Title	Bioavailability of Apixaban Oral Solution Administered Through a Nasogastric Tube in the Presence of Boost® Plus and Apixaban Administered as Crushed Tablet Through a Nasogastric Tube Relative to Apixaban Oral Solution in Healthy Subjects
Brief Summary	The purpose of this study is to assess the bioavailability of Apixaban oral solution administered through an Nasogastric Tube (NGT) in the presence of Boost® Plus and Apixaban administered as crushed tablet through a nasogastric tube relative to Apixaban solution administered orally 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 Subjects
Intervention	Drug: Apixaban Other Names: BMS-562247
Study Arm (s)	Experimental: Arm A-Apixaban Solution Apixaban 5 mg ( 0.4 mg/ml oral solution x 12.5 ml) through mouth or oral syringe Experimental: Arm B-Apixaban Oral Solution Apixaban 5 mg single dose (0.4 mg/mL oral solution x 12.5 mL) after 180 mL of Boost Plus®, followed by 60 mL of Boost Plus® via same NGT Experimental: Arm C-Apixaban Single dose crushed Apixaban tablet 5 mg (5 mg tablet crushed and suspended in 60 mL Dextrose 5% in water (D5W)) through NGT

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	21
Estimated Completion Date	November 2011
Estimated Primary Completion Date	November 2011
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 - Any history or evidence of abnormal bleeding or coagulation disorders, intracranial hemorrhage, or abnormal bleeding (including heavy menstrual bleeding that has resulted in anemia within the past 1 year) or coagulation disorders in a first degree relative
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT02034591
Other Study ID Numbers	CV185-111
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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