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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02262520

Enrollment

Registered

2014-10-13

Start date

2006-01-31

Completion date

2006-03-31

Last updated

2015-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N/A - Healthy Subjects

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.

Interventions

DRUGApixaban

DRUGDigoxin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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	Days 1-22

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026