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

Healthy Volunteers Clinical Trial

Official title:

Study of Apixaban Oral Solution Bioavailability When Administered Through a Nasogastric Tube in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034578
• Other study ID #: CV185-091
• Status: Completed
• Phase: Phase 1
• First received: January 10, 2014
• Last updated: January 10, 2014
• Start date: July 2011
• Est. completion date: August 2011

Study information

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

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2011
• Est. primary completion date: August 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 Volunteers

Intervention

Drug:
• Apixaban

Locations

Country	Name	City	State
United States	Parexel Baltimore Early Phase Clinical Unit	Baltimore	Maryland

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 solution administered through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban administered orally in healthy subjects		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
Secondary	Maximum observed plasma concentration (Cmax) of Apixaban		48 time points up to Day 12	No
Secondary	Time of maximum observed plasma concentration (Tmax) of Apixaban		48 time points up to Day 12	No
Secondary	Area under the plasma concentration-time curve from time zero to the time of last quantifiable plasma concentration [AUC(0-T)] of Apixaban		48 time points up to Day 12	No
Secondary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Apixaban		48 time points up to Day 12	No
Secondary	Plasma elimination half-life (T-HALF) of Apixaban		48 time points up to Day 12	No
Secondary	Relative bioavailability as calculated by ratio of AUC(INF) [Frel] of Apixaban		48 time points up to Day 12	No

External Links

•   BMS Clinical Trials Disclosure
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form