Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
- Registration Number
- NCT02262533
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A: Apixaban Apixaban Apixaban tablet by mouth on specified day Treatment C: Apixaban and Atenolol Atenolol Apixaban and Atenolol tablets by mouth on specified day Treatment C: Apixaban and Atenolol Apixaban Apixaban and Atenolol tablets by mouth on specified day Treatment B: Atenolol Atenolol Atenolol tablet by mouth on specified day
- Primary Outcome Measures
Name Time Method Apixaban and Atenolol plasma concentration Days 1-13 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)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Bms Clinical Research Center
🇺🇸Hamilton, New Jersey, United States