Phase 1 Drug Interaction Study of the Effect of Apixaban on the PK of Digoxin in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-03-31

Brief Summary

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The purpose of this study is to assess the effects of Apixaban on the Pharmacokinetics (PK) of multiple-dose Digoxin in healthy subjects.

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Detailed Description

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Conditions

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N/A - Healthy Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A: Digoxin

Digoxin tablet by mouth on specified days

Group Type EXPERIMENTAL

Digoxin

Intervention Type DRUG

Treatment B: Apixaban and Digoxin

Apixaban and Digoxin tablets by mouth on specified days

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Digoxin

Intervention Type DRUG

Interventions

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Apixaban

Intervention Type DRUG

Digoxin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes