<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/NCT04468815</url>
  </required_header>
  <id_info>
    <org_study_id>IM027-054</org_study_id>
    <nct_id>NCT04468815</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Levels in Blood Plasma of BMS-986278 in Healthy Participants Following Administration of Tablets, With or Without Food, and in the Presence of an Antacid (Esomeprazole)</brief_title>
  <official_title>An Open-Label Study to Assess Relative Bioavailability, Food Effect, and Esomeprazole Drug-Drug Interaction of BMS-986278 Tablets Following a Single Dose Administration in Healthy Participants</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>
      The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food&#xD;
      effect in healthy participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2020</start_date>
  <completion_date type="Actual">October 7, 2020</completion_date>
  <primary_completion_date type="Actual">October 7, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum plasma concentration (Cmax) of BMS-986278</measure>
    <time_frame>Up to 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed (AUC(0-T) of BMS-986278</measure>
    <time_frame>Up to 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration-time curve from time 0 (dosing) extrapolated to infinity AUC (INF) of BMS-986278 from the respective test treatments</measure>
    <time_frame>Up to 5 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events (AEs)</measure>
    <time_frame>Up to 29 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Serious Adverse (SAE's)</measure>
    <time_frame>Up to 57 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AEs leading to discontinuation</measure>
    <time_frame>Up to 29 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in vital signs: Blood pressure</measure>
    <time_frame>Up to 48 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in vital signs: Heart rate</measure>
    <time_frame>Up to 48 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in vital signs: Respiratory rate</measure>
    <time_frame>Up to 48 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in vital signs: Body temperature</measure>
    <time_frame>Up to 48 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in electrocardiogram (ECG) parameters</measure>
    <time_frame>Up to 48 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in physical examination findings</measure>
    <time_frame>Up to 48 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests</measure>
    <time_frame>Up to 48 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests</measure>
    <time_frame>Up to 48 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in clinical laboratory results: Hematology tests</measure>
    <time_frame>Up to 48 days</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>Treatment A: BMS-986278 suspension, fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B: BMS-986278 tablet, fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C: BMS-986278 tablet, fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986278 Tablet</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Treatment B: BMS-986278 tablet, fasted</arm_group_label>
    <arm_group_label>Treatment C: BMS-986278 tablet, fed</arm_group_label>
    <arm_group_label>Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Esomeprazole</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted</arm_group_label>
    <other_name>NEXIUM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986278 suspension</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Treatment A: BMS-986278 suspension, fasted</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy participants, as determined by no clinically significant deviation from normal&#xD;
             in medical history, physical examination, ECGs, and clinical laboratory determinations&#xD;
             in the opinion of the investigator&#xD;
&#xD;
          -  Women and men must agree to follow specific methods of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) and Women who are pregnant or breastfeeding&#xD;
&#xD;
          -  Any significant acute or chronic medical condition that presents a potential risk to&#xD;
             the participant and/or that may compromise the objectives of the study&#xD;
&#xD;
          -  Exposure to any investigational drug or placebo within 4 weeks of first study&#xD;
             treatment administration.&#xD;
&#xD;
          -  History of any significant drug and/or food allergies (such as anaphylaxis or&#xD;
             hepatotoxicity)&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 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>ICON (LPRA) - Salt Lake</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>May 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 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>Esomeprazole</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/NCT04468815
org study id: IM027-054
nct id: NCT04468815
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food
      effect in healthy participants.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum plasma concentration (Cmax) of BMS-986278
time frame: Up to 5 days
measure: Area under the concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed (AUC(0-T) of BMS-986278
time frame: Up to 5 days
measure: Area under the concentration-time curve from time 0 (dosing) extrapolated to infinity AUC (INF) of BMS-986278 from the respective test treatments
time frame: Up to 5 days
measure: Incidence of Adverse Events (AEs)
time frame: Up to 29 days
measure: Incidence of Serious Adverse (SAE's)
time frame: Up to 57 days
measure: Incidence of AEs leading to discontinuation
time frame: Up to 29 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
time frame: Up to 48 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
time frame: Up to 48 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
time frame: Up to 48 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
time frame: Up to 48 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters
time frame: Up to 48 days
measure: Incidence of clinically significant changes in physical examination findings
time frame: Up to 48 days
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests
time frame: Up to 48 days
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
time frame: Up to 48 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
time frame: Up to 48 days
arm group label: Treatment A: BMS-986278 suspension, fasted
arm group type: Experimental
arm group label: Treatment B: BMS-986278 tablet, fasted
arm group type: Experimental
arm group label: Treatment C: BMS-986278 tablet, fed
arm group type: Experimental
arm group label: Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted
arm group type: Experimental
intervention type: Drug
intervention name: BMS-986278 Tablet
description: Specified dose on specified days
arm group label: Treatment B: BMS-986278 tablet, fasted
arm group label: Treatment C: BMS-986278 tablet, fed
arm group label: Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted
intervention type: Drug
intervention name: Esomeprazole
description: Specified dose on specified days
arm group label: Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted
other name: NEXIUM
intervention type: Drug
intervention name: BMS-986278 suspension
description: Specified dose on specified days
arm group label: Treatment A: BMS-986278 suspension, fasted
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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: Esomeprazole