NCT02262520CompletedPhase 1
Effect of Apixaban on the Pharmacokinetics of Digoxin in Healthy Subjects
Bristol-Myers Squibb0 sites24 target enrollmentStarted: January 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Primary Endpoint
- Apixaban and Digoxin plasma concentration
Study Overview
Brief Summary
The purpose of this study is to assess the effects of Apixaban on the Pharmacokinetics (PK) of multiple-dose Digoxin in healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations
Exclusion Criteria
- •Any significant acute or chronic medical illness, history of important arrhythmias, history or evidence of abnormal bleeding or coagulation disorders, significant head injury within the last 2 years
Arms & Interventions
Treatment A: Digoxin
Experimental
Digoxin tablet by mouth on specified days
Intervention: Digoxin (Drug)
Treatment B: Apixaban and Digoxin
Experimental
Apixaban and Digoxin tablets by mouth on specified days
Intervention: Apixaban (Drug)
Treatment B: Apixaban and Digoxin
Experimental
Apixaban and Digoxin tablets by mouth on specified days
Intervention: Digoxin (Drug)
Outcomes
Primary Outcomes
Apixaban and Digoxin plasma concentration
Time Frame: Days 8-21
Blood samples for Digoxin were collected on Days 8, 9, 10, 11, 18, 19, 20 \& 21 Urine samples for Digoxin were collected for 24 hours post dose on Days 10 \& 20. Blood samples for Apixaban concentration were collected on Days 18-20
Secondary Outcomes
- Safety and Tolerability based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, electrocardiograms, digoxin concentrations,and clinical laboratory tests(Days 1-22)
Investigators
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