<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02262533</url>
  </required_header>
  <id_info>
    <org_study_id>CV185-033</org_study_id>
    <nct_id>NCT02262533</nct_id>
  </id_info>
  <brief_title>Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects</brief_title>
  <official_title>Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics&#xD;
      (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2007</start_date>
  <completion_date type="Actual">June 2007</completion_date>
  <primary_completion_date type="Actual">June 2007</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apixaban and Atenolol plasma concentration</measure>
    <time_frame>Days 1-13</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability based on adverse events (AE) reports and the results of vital sign measurements, electrocardiogram (ECGs), physical examinations, and clinical laboratory tests</measure>
    <time_frame>Days 1-13</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>N/A - Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Treatment A: Apixaban</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apixaban tablet by mouth on specified day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B: Atenolol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Atenolol tablet by mouth on specified day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C: Apixaban and Atenolol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apixaban and Atenolol tablets by mouth on specified day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apixaban</intervention_name>
    <arm_group_label>Treatment A: Apixaban</arm_group_label>
    <arm_group_label>Treatment C: Apixaban and Atenolol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atenolol</intervention_name>
    <arm_group_label>Treatment B: Atenolol</arm_group_label>
    <arm_group_label>Treatment C: Apixaban and Atenolol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects as determined by no clinically significant deviation from normal in&#xD;
             medical history, physical examination, electrocardiogram (ECGs), and clinical&#xD;
             laboratory determinations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any significant acute or chronic medical illness, history of hypotension, history or&#xD;
             evidence of abnormal bleeding or coagulation disorders, significant head injury within&#xD;
             the last 2 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bms Clinical Research Center</name>
      <address>
        <city>Hamilton</city>
        <state>New Jersey</state>
        <zip>08690</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>August 6, 2015</last_update_submitted>
  <last_update_submitted_qc>August 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atenolol</mesh_term>
    <mesh_term>Apixaban</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02262533
org study id: CV185-033
nct id: NCT02262533
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Apixaban and Atenolol plasma concentration
time frame: Days 1-13
description: 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)
measure: 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
arm group label: Treatment A: Apixaban
arm group type: Experimental
description: Apixaban tablet by mouth on specified day
arm group label: Treatment B: Atenolol
arm group type: Experimental
description: Atenolol tablet by mouth on specified day
arm group label: Treatment C: Apixaban and Atenolol
arm group type: Experimental
description: Apixaban and Atenolol tablets by mouth on specified day
intervention type: Drug
intervention name: Apixaban
arm group label: Treatment A: Apixaban
arm group label: Treatment C: Apixaban and Atenolol
intervention type: Drug
intervention name: Atenolol
arm group label: Treatment B: Atenolol
arm group label: Treatment C: Apixaban and Atenolol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
country: United States
responsible party type: Sponsor
mesh term: Atenolol
mesh term: Apixaban