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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02262533
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : August 10, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
N/A - Healthy Subjects Drug: Apixaban Drug: Atenolol Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
Study Start Date : June 2007
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Apixaban and Atenolol plasma concentration [ Time Frame: 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 :
  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 [ Time Frame: Days 1-13 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262533


Locations
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United States, New Jersey
Bms Clinical Research Center
Hamilton, New Jersey, United States, 08690
Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02262533    
Other Study ID Numbers: CV185-033
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Atenolol
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents