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

Bristol-Myers Squibb24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

N/A - Healthy Subjects

Interventions

ApixabanDRUG

DigoxinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Apixaban and Digoxin plasma concentration

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

Time frame: Days 8-21

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.