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

Phase 1 Oral Solution 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 solution administered through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban solution administered orally in healthy subjects
Condition	Healthy Volunteers
Intervention	Drug: Apixaban
Phase	Phase 1
Sponsor	Bristol-Myers Squibb
Responsible Party	Bristol-Myers Squibb
ClinicalTrials.gov Identifier	NCT02034578
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	July 2011
Estimated Primary Completion Date	August 2011
Current Primary Outcome Measures	Bioavailability of Apixaban solution administered through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban administered orally in healthy subjects [Time Frame: Up to Day 12] [Designated as safety issue: No]
Current Secondary Outcome Measures	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] Maximum observed plasma concentration (Cmax) of Apixaban [Time Frame: 48 time points up to Day 12] [Designated as safety issue: No] Time of maximum observed plasma concentration (Tmax) of Apixaban [Time Frame: 48 time points up to Day 12] [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 [Time Frame: 48 time points 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 [Time Frame: 48 time points up to Day 12] [Designated as safety issue: No] Plasma elimination half-life (T-HALF) of Apixaban [Time Frame: 48 time points up to Day 12] [Designated as safety issue: No] Relative bioavailability as calculated by ratio of AUC(INF) [Frel] of Apixaban [Time Frame: 48 time points up to Day 12] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Phase 1 Oral Solution Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects
Official Title	Study of Apixaban Oral Solution Bioavailability When Administered Through a Nasogastric Tube in Healthy Subjects
Brief Summary	The purpose of this study is to assess the bioavailability of Apixaban solution administered through NGT and washed with Dextrose 5% in water (D5W) or infant formula 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 Volunteers
Intervention	Drug: Apixaban Other Names: BMS-562247
Study Arm (s)	Experimental: Arm A: Apixaban Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via oral syringe Experimental: Arm B: Apixaban Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via nasogastric tube (NGT) immediately followed by 60 mL of D5W via NGT Experimental: Arm C: Apixaban Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via NGT immediately followed by 60 mL of infant formula via NGT

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	21
Estimated Completion Date	August 2011
Estimated Primary Completion Date	August 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	NCT02034578
Other Study ID Numbers	CV185-091
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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