<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/NCT04464577</url>
  </required_header>
  <id_info>
    <org_study_id>CV018-014</org_study_id>
    <nct_id>NCT04464577</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Drug Levels and Safety of BMS-986235</brief_title>
  <official_title>A Phase 1, Open-label Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Pharmacokinetics and Safety of BMS-986235</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the effect of inhibitors, at steady state, on the drug levels,&#xD;
      safety, and tolerability of BMS-986235 when taken by healthy participants. The inhibitors to&#xD;
      be utilized in this study are fluconazole, bupropion, and itraconazole.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Business objectives have changed.&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 1, 2021</start_date>
  <completion_date type="Anticipated">June 8, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 7, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with fluconazole</measure>
    <time_frame>Day 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum plasma concentration (Cmax) of BMS-986235 with fluconazole</measure>
    <time_frame>Day 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with fluconazole</measure>
    <time_frame>Day 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with bupropion</measure>
    <time_frame>Day 13</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with bupropion</measure>
    <time_frame>Day 13</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum plasma concentration (Cmax) of BMS-986235 with bupropion</measure>
    <time_frame>Day 13</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with itraconazole</measure>
    <time_frame>Day 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with itraconazole</measure>
    <time_frame>Day 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole</measure>
    <time_frame>Day 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum plasma concentration (Cmax) of BMS-986235</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Nonserious Adverse Events (AEs)</measure>
    <time_frame>Up to 49 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 77 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AEs leading to discontinuation</measure>
    <time_frame>Up to 16 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant changes from baseline in vital signs: Body Temperature</measure>
    <time_frame>Up to 44 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant changes from baseline in physical examinations</measure>
    <time_frame>Up to 44 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant changes in clinical laboratory tests: Hematology</measure>
    <time_frame>Up to 44 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant changes in clinical laboratory tests: Clinical Chemistry</measure>
    <time_frame>Up to 44 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant changes in clinical laboratory tests: Coagulation</measure>
    <time_frame>Up to 44 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant changes in clinical laboratory tests: Urinalysis</measure>
    <time_frame>Up to 44 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant changes from baseline in vital signs: Respiratory Rate</measure>
    <time_frame>Up to 44 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant changes from baseline in vital signs: Heart Rate</measure>
    <time_frame>Up to 44 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant changes from baseline in vital signs:Blood Pressure</measure>
    <time_frame>Up to 44 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant changes in electrocardiogram (ECG)</measure>
    <time_frame>Up to 44 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))</measure>
    <time_frame>Up to 44 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>Arm A: BMS-986235+Fluconazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: BMS-986235+ Bupropion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C: BMS-986235+ Itraconazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluconazole</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Arm A: BMS-986235+Fluconazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupropion</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Arm B: BMS-986235+ Bupropion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itraconazole</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Arm C: BMS-986235+ Itraconazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986235</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Arm A: BMS-986235+Fluconazole</arm_group_label>
    <arm_group_label>Arm B: BMS-986235+ Bupropion</arm_group_label>
    <arm_group_label>Arm C: BMS-986235+ Itraconazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.&#xD;
&#xD;
          -  Males and females must agree to follow specific methods of contraception, if&#xD;
             applicable.&#xD;
&#xD;
          -  Healthy participants, as determined by no clinically significant deviation from normal&#xD;
             in physical examination, ECGs, and clinical laboratory determinations, and no&#xD;
             significant findings in medical history.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP), women who are pregnant or breastfeeding&#xD;
&#xD;
          -  Inability to tolerate oral medication&#xD;
&#xD;
          -  Known previous exposure to BMS-986235.&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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>Local Institution</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>Investigator Inquiry Form</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>March 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>March 10, 2022</last_update_submitted>
  <last_update_submitted_qc>March 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2022</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>Itraconazole</mesh_term>
    <mesh_term>Fluconazole</mesh_term>
    <mesh_term>Bupropion</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/NCT04464577
org study id: CV018-014
nct id: NCT04464577
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the effect of inhibitors, at steady state, on the drug levels,
      safety, and tolerability of BMS-986235 when taken by healthy participants. The inhibitors to
      be utilized in this study are fluconazole, bupropion, and itraconazole.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with fluconazole
time frame: Day 12
measure: Maximum plasma concentration (Cmax) of BMS-986235 with fluconazole
time frame: Day 12
measure: Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with fluconazole
time frame: Day 12
measure: Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with bupropion
time frame: Day 13
measure: Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with bupropion
time frame: Day 13
measure: Maximum plasma concentration (Cmax) of BMS-986235 with bupropion
time frame: Day 13
measure: Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with itraconazole
time frame: Day 9
measure: Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with itraconazole
time frame: Day 9
measure: Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole
time frame: Day 9
measure: Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235
time frame: Day 1
measure: Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235
time frame: Day 1
measure: Maximum plasma concentration (Cmax) of BMS-986235
time frame: Day 1
measure: Incidence of Nonserious Adverse Events (AEs)
time frame: Up to 49 days
measure: Incidence of Serious Adverse Events (SAEs)
time frame: Up to 77 days
measure: Incidence of AEs leading to discontinuation
time frame: Up to 16 days
measure: Number of clinically significant changes from baseline in vital signs: Body Temperature
time frame: Up to 44 days
measure: Number of clinically significant changes from baseline in physical examinations
time frame: Up to 44 days
measure: Number of clinically significant changes in clinical laboratory tests: Hematology
time frame: Up to 44 days
measure: Number of clinically significant changes in clinical laboratory tests: Clinical Chemistry
time frame: Up to 44 days
measure: Number of clinically significant changes in clinical laboratory tests: Coagulation
time frame: Up to 44 days
measure: Number of clinically significant changes in clinical laboratory tests: Urinalysis
time frame: Up to 44 days
measure: Number of clinically significant changes from baseline in vital signs: Respiratory Rate
time frame: Up to 44 days
measure: Number of clinically significant changes from baseline in vital signs: Heart Rate
time frame: Up to 44 days
measure: Number of clinically significant changes from baseline in vital signs:Blood Pressure
time frame: Up to 44 days
measure: Number of clinically significant changes in electrocardiogram (ECG)
time frame: Up to 44 days
measure: Number of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))
time frame: Up to 44 days
arm group label: Arm A: BMS-986235+Fluconazole
arm group type: Experimental
arm group label: Arm B: BMS-986235+ Bupropion
arm group type: Experimental
arm group label: Arm C: BMS-986235+ Itraconazole
arm group type: Experimental
intervention type: Drug
intervention name: Fluconazole
description: Specified Dose on Specified Days
arm group label: Arm A: BMS-986235+Fluconazole
intervention type: Drug
intervention name: Bupropion
description: Specified Dose on Specified Days
arm group label: Arm B: BMS-986235+ Bupropion
intervention type: Drug
intervention name: Itraconazole
description: Specified Dose on Specified Days
arm group label: Arm C: BMS-986235+ Itraconazole
intervention type: Drug
intervention name: BMS-986235
description: Specified Dose on Specified Days
arm group label: Arm A: BMS-986235+Fluconazole
arm group label: Arm B: BMS-986235+ Bupropion
arm group label: Arm C: BMS-986235+ Itraconazole
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
facility: 
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: Investigator Inquiry Form
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Itraconazole
mesh term: Fluconazole
mesh term: Bupropion