Phase 1 Drug Interaction Study of the Effect of Apixaban on the PK of Digoxin in Healthy Subjects
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: N/A - Healthy Subjects
Intervention: Apixaban (Drug); Digoxin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Summary
The purpose of this study is to assess the effects of Apixaban on the Pharmacokinetics (PK)
of multiple-dose Digoxin in healthy subjects.
Clinical Details
Official title: Effect of Apixaban on the Pharmacokinetics of Digoxin in Healthy Subjects
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Apixaban and Digoxin plasma concentration
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: January 2006
Last updated: August 6, 2015
|