NCT02262533

Brief Summary

The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

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

June 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
7.4 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

Same day

First QC Date

October 9, 2014

Last Update Submit

August 6, 2015

Conditions

N/A - Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Apixaban and Atenolol plasma concentration

    Blood samples for Atenolol PK were collected on days 1-3 of each period (Treatment B and C). Blood samples for Apixaban PK were collected on days 1-4 of each period (Treatment A and C)

    Days 1-13

Secondary Outcomes (1)

  • Safety and Tolerability based on adverse events (AE) reports and the results of vital sign measurements, electrocardiogram (ECGs), physical examinations, and clinical laboratory tests

    Days 1-13

Study Arms (3)

Treatment A: Apixaban

EXPERIMENTAL

Apixaban tablet by mouth on specified day

Drug: Apixaban

Treatment B: Atenolol

EXPERIMENTAL

Atenolol tablet by mouth on specified day

Drug: Atenolol

Treatment C: Apixaban and Atenolol

EXPERIMENTAL

Apixaban and Atenolol tablets by mouth on specified day

Drug: ApixabanDrug: Atenolol

Interventions

ApixabanDRUG
Treatment A: ApixabanTreatment C: Apixaban and Atenolol
AtenololDRUG
Treatment B: AtenololTreatment C: Apixaban and Atenolol

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 hypotension, 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

Study Sites (1)

Bms Clinical Research Center

Hamilton, New Jersey, 08690, United States

Location

MeSH Terms

Interventions

apixabanAtenolol

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 13, 2014

Study Start

June 1, 2007

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

August 10, 2015

Record last verified: 2015-08

Locations

US(1)