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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: N/A - Healthy Subjects

Treatments: Drug: Apixaban; Drug: Atenolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02262533

CV185-033

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Treatment A: Apixaban

Experimental group

Description:

Apixaban tablet by mouth on specified day

Treatment:

Drug: Apixaban

Treatment B: Atenolol

Experimental group

Description:

Atenolol tablet by mouth on specified day

Treatment:

Drug: Atenolol

Treatment C: Apixaban and Atenolol

Experimental group

Description:

Apixaban and Atenolol tablets by mouth on specified day

Treatment:

Drug: Atenolol

Drug: Apixaban