<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/NCT02227173</url>
  </required_header>
  <id_info>
    <org_study_id>IM136-004</org_study_id>
    <nct_id>NCT02227173</nct_id>
  </id_info>
  <brief_title>A Phase 1 Drug-drug Interaction Study in Healthy Volunteers</brief_title>
  <acronym>DDI</acronym>
  <official_title>Effect of BMS-986020 on the Pharmacokinetics of Montelukast, Flurbiprofen, and Digoxin as Probe Substrates for CYP2C8, CYP2C9, and P-gp</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <brief_summary>
    <textblock>
      This is an open-label, single-sequence, drug-drug interaction study in healthy male and&#xD;
      female subjects. There is no formal research hypothesis to be statistically tested. It is&#xD;
      expected that coadministration of BMS-986020 with montelukast, flurbiprofen, and digoxin may&#xD;
      increase the exposure of montelukast, flurbiprofen, and digoxin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic parameters (maximum observed plasma concentration, area under the concentration-time curve) for montelukast, flurbiprofen, and digoxin</measure>
    <time_frame>Predose and up to 168 hours post dose</time_frame>
    <description>Pharmacokinetic endpoints for montelukast, flurbiprofen, and digoxin with and without BMS-986020</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Additional pharmacokinetic parameters for montelukast, flurbiprofen, and digoxin.</measure>
    <time_frame>Predose and up to 168 hour post dose</time_frame>
    <description>Additional pharmacokinetic parameters for montelukast, flurbiprofen, digoxin, and with and without BMS-986020</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>From dosing (Day 1) to Day 21</time_frame>
    <description>Collection of adverse events and other physical parameters to assess safety</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Drug-drug Interaction Study</condition>
  <arm_group>
    <arm_group_label>Single-Sequence, A B C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment A:&#xD;
Single oral dose of montelukast, flurbiprofen, and digoxin on Day 1&#xD;
Treatment B:&#xD;
BMS-986020 orally twice daily (BID) on Day 8 through Day 10&#xD;
Treatment C:&#xD;
BMS-986020 orally BID, single oral dose of montelukast, flurbiprofen, and digoxin on Day 11; BMS-986020 BID on Day 12 through Day 17</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986020</intervention_name>
    <arm_group_label>Single-Sequence, A B C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Montelukast</intervention_name>
    <arm_group_label>Single-Sequence, A B C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flurbiprofen</intervention_name>
    <arm_group_label>Single-Sequence, A B C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Digoxin</intervention_name>
    <arm_group_label>Single-Sequence, A B C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive, with a&#xD;
             body mass index of 18.0 to 32.0 kg/m2, inclusive&#xD;
&#xD;
          -  Women of childbearing potential must agree to follow instructions for methods of&#xD;
             contraception for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any significant acute or chronic medical illness&#xD;
&#xD;
          -  History of arrhythmias or palpitations associated with dizziness or fainting&#xD;
&#xD;
          -  History of clinically relevant cardiac disease&#xD;
&#xD;
        Other protocol defined exclusion criteria could apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emanuel DeNoia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ICON Development Solutions</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Healthcare Discoveries, LLC d/b/a ICON Development Solutions</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>November 17, 2014</last_update_submitted>
  <last_update_submitted_qc>November 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2014</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>Flurbiprofen</mesh_term>
    <mesh_term>Digoxin</mesh_term>
    <mesh_term>Montelukast</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/NCT02227173
org study id: IM136-004
nct id: NCT02227173
lead sponsor: 
This is an open-label, single-sequence, drug-drug interaction study in healthy male and
      female subjects. There is no formal research hypothesis to be statistically tested. It is
      expected that coadministration of BMS-986020 with montelukast, flurbiprofen, and digoxin may
      increase the exposure of montelukast, flurbiprofen, and digoxin.
allocation: Non-Randomized
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Pharmacokinetic parameters (maximum observed plasma concentration, area under the concentration-time curve) for montelukast, flurbiprofen, and digoxin
time frame: Predose and up to 168 hours post dose
description: Pharmacokinetic endpoints for montelukast, flurbiprofen, and digoxin with and without BMS-986020
measure: Additional pharmacokinetic parameters for montelukast, flurbiprofen, and digoxin.
time frame: Predose and up to 168 hour post dose
description: Additional pharmacokinetic parameters for montelukast, flurbiprofen, digoxin, and with and without BMS-986020
measure: Safety
time frame: From dosing (Day 1) to Day 21
description: Collection of adverse events and other physical parameters to assess safety
arm group label: Single-Sequence, A B C
arm group type: Experimental
description: Treatment A:
Single oral dose of montelukast, flurbiprofen, and digoxin on Day 1
Treatment B:
BMS-986020 orally twice daily (BID) on Day 8 through Day 10
Treatment C:
BMS-986020 orally BID, single oral dose of montelukast, flurbiprofen, and digoxin on Day 11; BMS-986020 BID on Day 12 through Day 17
intervention type: Drug
intervention name: BMS-986020
arm group label: Single-Sequence, A B C
intervention type: Drug
intervention name: Montelukast
arm group label: Single-Sequence, A B C
intervention type: Drug
intervention name: Flurbiprofen
arm group label: Single-Sequence, A B C
intervention type: Drug
intervention name: Digoxin
arm group label: Single-Sequence, A B C
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Emanuel DeNoia, MD
role: Principal Investigator
affiliation: ICON Development Solutions
facility: 
country: United States
responsible party type: Sponsor
mesh term: Flurbiprofen
mesh term: Digoxin
mesh term: Montelukast