NCT02262520

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
Last Updated

August 10, 2015

Status Verified

August 1, 2015

Enrollment Period

2 months

First QC Date

October 9, 2014

Last Update Submit

August 6, 2015

Conditions

N/A - Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • 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

    Days 8-21

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

    Days 1-22

Study Arms (2)

Treatment A: Digoxin

EXPERIMENTAL

Digoxin tablet by mouth on specified days

Drug: Digoxin

Treatment B: Apixaban and Digoxin

EXPERIMENTAL

Apixaban and Digoxin tablets by mouth on specified days

Drug: ApixabanDrug: Digoxin

Interventions

ApixabanDRUG
Treatment B: Apixaban and Digoxin
DigoxinDRUG
Treatment A: DigoxinTreatment B: Apixaban and Digoxin

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

apixabanDigoxin

Intervention Hierarchy (Ancestors)

Digitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 13, 2014

Study Start

January 1, 2006

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

August 10, 2015

Record last verified: 2015-08