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

Bristol-Myers Squibb15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

N/A - Healthy Subjects

Interventions

ApixabanDRUG

AtenololDRUG

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 hypotension, history or evidence of abnormal bleeding or coagulation disorders, significant head injury within the last 2 years

Locations (1)

Bms Clinical Research Center

Hamilton, New Jersey, United States

Outcomes

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

Data from ClinicalTrials.gov

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