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OpenTrials
Completed

NCT Number: NCT02262520

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

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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Key information

Conditions

N/A - Healthy Subjects

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apixaban

Drug

Digoxin

Drug

Primary outcomes

  1. Apixaban and Digoxin plasma concentration

    Time frame: 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Pfizer

Registry information

Official study title

Effect of Apixaban on the Pharmacokinetics of Digoxin in Healthy Subjects

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Oct 13, 2014
Registry last updated
Aug 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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