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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: N/A - Healthy Subjects

Treatments: Drug: Apixaban; Drug: Digoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02262520

CV185-028

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Treatment A: Digoxin

Experimental group

Description:

Digoxin tablet by mouth on specified days

Treatment:

Drug: Digoxin

Treatment B: Apixaban and Digoxin

Experimental group

Description:

Apixaban and Digoxin tablets by mouth on specified days

Treatment:

Drug: Apixaban

Drug: Digoxin