<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/NCT02262520</url>
  </required_header>
  <id_info>
    <org_study_id>CV185-028</org_study_id>
    <nct_id>NCT02262520</nct_id>
  </id_info>
  <brief_title>Phase 1 Drug Interaction Study of the Effect of Apixaban on the PK of Digoxin in Healthy Subjects</brief_title>
  <official_title>Effect of Apixaban on the Pharmacokinetics of Digoxin 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 effects of Apixaban on the Pharmacokinetics (PK)&#xD;
      of multiple-dose Digoxin in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2006</start_date>
  <completion_date type="Actual">March 2006</completion_date>
  <primary_completion_date type="Actual">March 2006</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apixaban and Digoxin plasma concentration</measure>
    <time_frame>Days 8-21</time_frame>
    <description>Blood samples for Digoxin were collected on Days 8, 9, 10, 11, 18, 19, 20 &amp; 21 Urine samples for Digoxin were collected for 24 hours post dose on Days 10 &amp; 20. Blood samples for Apixaban concentration were collected on Days 18-20</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, electrocardiograms, digoxin concentrations,and clinical laboratory tests</measure>
    <time_frame>Days 1-22</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>N/A - Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Treatment A: Digoxin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Digoxin tablet by mouth on specified days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B: Apixaban and Digoxin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apixaban and Digoxin tablets by mouth on specified days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apixaban</intervention_name>
    <arm_group_label>Treatment B: Apixaban and Digoxin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Digoxin</intervention_name>
    <arm_group_label>Treatment A: Digoxin</arm_group_label>
    <arm_group_label>Treatment B: Apixaban and Digoxin</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 laboratory&#xD;
        determinations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Any significant acute or chronic medical illness, history of important arrhythmias,&#xD;
        history or evidence of abnormal bleeding or coagulation disorders, significant head injury&#xD;
        within 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>
  <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>Digoxin</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/NCT02262520
org study id: CV185-028
nct id: NCT02262520
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess the effects of Apixaban on the Pharmacokinetics (PK)
      of multiple-dose Digoxin in healthy subjects.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Apixaban and Digoxin plasma concentration
time frame: Days 8-21
description: Blood samples for Digoxin were collected on Days 8, 9, 10, 11, 18, 19, 20 & 21 Urine samples for Digoxin were collected for 24 hours post dose on Days 10 & 20. Blood samples for Apixaban concentration were collected on Days 18-20
measure: Safety and Tolerability based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, electrocardiograms, digoxin concentrations,and clinical laboratory tests
time frame: Days 1-22
arm group label: Treatment A: Digoxin
arm group type: Experimental
description: Digoxin tablet by mouth on specified days
arm group label: Treatment B: Apixaban and Digoxin
arm group type: Experimental
description: Apixaban and Digoxin tablets by mouth on specified days
intervention type: Drug
intervention name: Apixaban
arm group label: Treatment B: Apixaban and Digoxin
intervention type: Drug
intervention name: Digoxin
arm group label: Treatment A: Digoxin
arm group label: Treatment B: Apixaban and Digoxin
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
responsible party type: Sponsor
mesh term: Digoxin
mesh term: Apixaban