xml: <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/NCT06034899</url>
    </required_header>
    <id_info>
      <org_study_id>IM038-1014</org_study_id>
      <nct_id>NCT06034899</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants</brief_title>
    <official_title>A Phase 1, 2-part, Open-label, Randomized, 2-period, 2-sequence, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-986196 Phase 2 Tablet Formulation at Two Dose Levels in Healthy Adult 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 the drug levels of BMS-986196 and to evaluate the&#xD;
        effect of food (fasted versus fed [high-fat meal]) on the drug levels after administration of&#xD;
        BMS-986196 tablet formulation at two dose levels in healthy adult participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 22, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</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>Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])</measure>
      <time_frame>Predose and post-dose up to Day 10</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum observed serum concentration (Cmax)</measure>
      <time_frame>Predose and post-dose up to Day 10</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Time of Cmax (Tmax)</measure>
      <time_frame>Predose and post-dose up to Day 10</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with adverse events (AEs)</measure>
      <time_frame>Up to Day 36</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with serious AEs (SAEs)</measure>
      <time_frame>Up to Day 36</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with vital sign abnormalities</measure>
      <time_frame>Up to Day 11</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with electrocardiogram (ECG) abnormalities</measure>
      <time_frame>Up to Day 11</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in columbia-suicide severity rating scale (C-SSRS) at day 11</measure>
      <time_frame>Baseline, Day 11</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with physical examination findings</measure>
      <time_frame>Up to Day 11</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with clinical laboratory abnormalities</measure>
      <time_frame>Up to Day 11</time_frame>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Healthy Adult Volunteers</condition>
    <arm_group>
      <arm_group_label>Part 1: BMS-986196 Dose 1 (Treatment A)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1: BMS-986196 Dose 1 (Treatment B)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2: BMS-986196 Dose 2 (Treatment A)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2: BMS-986196 Dose 2 (Treatment B)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BMS-986196</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>Part 1: BMS-986196 Dose 1 (Treatment A)</arm_group_label>
      <arm_group_label>Part 1: BMS-986196 Dose 1 (Treatment B)</arm_group_label>
      <arm_group_label>Part 2: BMS-986196 Dose 2 (Treatment A)</arm_group_label>
      <arm_group_label>Part 2: BMS-986196 Dose 2 (Treatment B)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy male participants and female participants without clinically significant&#xD;
               deviation from normal, as determined by the investigator, in medical history, physical&#xD;
               examination, vital signs, 12-lead ECG, and clinical laboratory assessments.&#xD;
  &#xD;
            -  Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m^2), inclusive, and body&#xD;
               weight ≥ 50 kg.&#xD;
  &#xD;
            -  Participant must agree and be willing to consume a standard high-fat meal (for&#xD;
               example, which may contain gluten).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any significant acute or chronic medical illness in the assessment of the&#xD;
               investigator.&#xD;
  &#xD;
            -  Current or recent (within 3 months of study intervention) gastrointestinal (GI)&#xD;
               disease that could possibly affect drug absorption, distribution, metabolism, and&#xD;
               excretion (e.g., bariatric procedure)&#xD;
  &#xD;
            -  Any major surgery, including GI surgery (for example, cholecystectomy and any other GI&#xD;
               surgery) that could impact upon the absorption of study intervention (uncomplicated&#xD;
               appendectomy and hernia repair are acceptable).&#xD;
  &#xD;
          Note: Other protocol-defined inclusion/exclusion criteria apply.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 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>
    <overall_contact>
      <last_name>BMS Study Connect Contact Center www.BMSStudyConnect.com</last_name>
      <phone>855-907-3286</phone>
      <email>Clinical.Trials@bms.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>First line of the email MUST contain the NCT# and Site #.</last_name>
    </overall_contact_backup>
    <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.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
      <description>FDA Safety Alerts and Recalls</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>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>BMS-986196</keyword>
    <keyword>Healthy adult participants</keyword>
    <keyword>Pharmacokinetics</keyword>
    <keyword>Cross-over study</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034899
  org study id: IM038-1014
  nct id: NCT06034899
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to assess the drug levels of BMS-986196 and to evaluate the
        effect of food (fasted versus fed [high-fat meal]) on the drug levels after administration of
        BMS-986196 tablet formulation at two dose levels in healthy adult participants.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
  time frame: Predose and post-dose up to Day 10
  measure: Maximum observed serum concentration (Cmax)
  time frame: Predose and post-dose up to Day 10
  measure: Time of Cmax (Tmax)
  time frame: Predose and post-dose up to Day 10
  measure: Number of participants with adverse events (AEs)
  time frame: Up to Day 36
  measure: Number of participants with serious AEs (SAEs)
  time frame: Up to Day 36
  measure: Number of participants with vital sign abnormalities
  time frame: Up to Day 11
  measure: Number of participants with electrocardiogram (ECG) abnormalities
  time frame: Up to Day 11
  measure: Change from baseline in columbia-suicide severity rating scale (C-SSRS) at day 11
  time frame: Baseline, Day 11
  measure: Number of participants with physical examination findings
  time frame: Up to Day 11
  measure: Number of participants with clinical laboratory abnormalities
  time frame: Up to Day 11
  arm group label: Part 1: BMS-986196 Dose 1 (Treatment A)
  arm group type: Experimental
  arm group label: Part 1: BMS-986196 Dose 1 (Treatment B)
  arm group type: Experimental
  arm group label: Part 2: BMS-986196 Dose 2 (Treatment A)
  arm group type: Experimental
  arm group label: Part 2: BMS-986196 Dose 2 (Treatment B)
  arm group type: Experimental
  intervention type: Drug
  intervention name: BMS-986196
  description: Specified dose on specified days
  arm group label: Part 1: BMS-986196 Dose 1 (Treatment A)
  arm group label: Part 1: BMS-986196 Dose 1 (Treatment B)
  arm group label: Part 2: BMS-986196 Dose 2 (Treatment A)
  arm group label: Part 2: BMS-986196 Dose 2 (Treatment B)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bristol-Myers Squibb
  role: Study Director
  affiliation: Bristol-Myers Squibb
  last name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  phone: 855-907-3286
  email: Clinical.Trials@bms.com
  last name: First line of the email MUST contain the NCT# and Site #.
  url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
  description: BMS Clinical Trial Information
  url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
  description: FDA Safety Alerts and Recalls
  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
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html