CompletedNCT02262533Updated Aug 10, 2015

Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects

A Phase 1 interventional study of Apixaban and Atenolol in N/A - Healthy Subjects, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-10.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 15
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study 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.

Conditions studied

N/A - Healthy Subjects

In context

Lead sponsor

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Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 15 participants (actual)

Study arms

Experimental
Treatment A: Apixaban
Apixaban tablet by mouth on specified day
Drug: Apixaban
Experimental
Treatment B: Atenolol
Atenolol tablet by mouth on specified day
Drug: Atenolol
Experimental
Treatment C: Apixaban and Atenolol
Apixaban and Atenolol tablets by mouth on specified day
Drug: Apixaban · Drug: Atenolol

Interventions

DrugApixaban
DrugAtenolol

What researchers measure

Primary outcomes

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)
Time frame: Days 1-13

Secondary outcomes

Safety and Tolerability based on adverse events (AE) reports and the results of vital sign measurements, electrocardiogram (ECGs), physical examinations, and clinical laboratory tests
Time frame: Days 1-13

Study locations

1 site

Bms Clinical Research Center
Hamilton, New Jersey 08690, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02262533
Lead sponsor: Bristol-Myers Squibb
Collaborators: Pfizer
Responsible party: Sponsor
First posted: Oct 13, 2014
Start date: Jun 2007
Primary completion: Jun 2007
Completion: Jun 2007
Last update: Aug 10, 2015

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Apixaban · Atenolol

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