Phase 1 Drug Interaction Study of the Effect of Apixaban on the PK of Digoxin in Healthy Subjects
- Registration Number
- NCT02262520
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations
• 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment B: Apixaban and Digoxin Apixaban Apixaban and Digoxin tablets by mouth on specified days Treatment B: Apixaban and Digoxin Digoxin Apixaban and Digoxin tablets by mouth on specified days Treatment A: Digoxin Digoxin Digoxin tablet by mouth on specified days
- Primary Outcome Measures
Name Time Method Apixaban and Digoxin plasma concentration 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 Outcome Measures
Name Time Method 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