- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02262520
Phase 1 Drug Interaction Study of the Effect of Apixaban on the PK of Digoxin in Healthy Subjects
Effect of Apixaban on the Pharmacokinetics of Digoxin in Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment A: Digoxin
Digoxin tablet by mouth on specified days
|
|
Experimental: Treatment B: Apixaban and Digoxin
Apixaban and Digoxin tablets by mouth on specified days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Days 8-21
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: Days 1-22
|
Days 1-22
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CV185-028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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