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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034591
• Other study ID #: CV185-111
• Status: Completed
• Phase: Phase 1
• First received: January 10, 2014
• Last updated: January 10, 2014
• Start date: October 2011
• Est. completion date: November 2011

Study information

• Verified date: January 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Apixaban

Locations

Country	Name	City	State
United States	Healthcare Discoveries, LLC D/B/A Icon Development Solutions	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability of Apixaban oral solution (OS) administered through NGT in the presence of Boost Plus® relative to Apixaban solution administered orally in healthy subjects		Up to Day 12	No
Secondary	Bioavailability of Apixaban crushed tablet administered through NGT relative to Apixaban solution administered orally in healthy subjects		Up to Day 12	No
Secondary	Maximum observed plasma concentration (Cmax) of Apixaban will be derived from plasma concentration versus time		48 timepoints up to Day 12	No
Secondary	Time of maximum observed plasma concentration (Tmax) of Apixaban will be derived from plasma concentration versus time		48 timepoints up to Day 12	No
Secondary	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		48 timepoints up to Day 12	No
Secondary	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		48 timepoints up to Day 12	No
Secondary	Plasma elimination half-life (T-HALF) of Apixaban will be derived from plasma concentration versus time		48 timepoints up to Day 12	No
Secondary	Relative bioavailability as calculated by ratio of AUC(INF) (Frel) of Apixaban will be derived from plasma concentration versus time		48 timepoints up to Day 12	No
Secondary	Safety assessed by incidence of adverse events, results of vital sign measurements, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests		Up to Day 12	Yes

External Links

•   BMS Clinical Trials Disclosure
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