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/NCT05963932</url>
    </required_header>
    <id_info>
      <org_study_id>CN007-1001</org_study_id>
      <nct_id>NCT05963932</nct_id>
    </id_info>
    <brief_title>A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult Participants</brief_title>
    <official_title>A Phase 1, Open-label, Randomized, Parallel-group, Single Dose Study to Assess the Relative Bioavailability of a New BMS-986419 Immediate-release Tablet Formulation Compared to a Reference Enteric Capsule (Delayed-release) Formulation, and to Assess the Effect of Food on the Pharmacokinetics of Immediate-release Tablet Formulation 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 impact of the BMS-986419 new immediate release&#xD;
        (IR) tablet formulation compared to the current enteric (DR) capsule formulation, and to&#xD;
        assess the effect of food on the drug levels of the IR tablet formulation in healthy adult&#xD;
        participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Anticipated">October 26, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 26, 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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum observed plasma concentration (Cmax)</measure>
      <time_frame>Up to 15 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])</measure>
      <time_frame>Up to 15 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])</measure>
      <time_frame>Up to 15 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with adverse events (AEs)</measure>
      <time_frame>Up to 29 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with vital sign abnormalities</measure>
      <time_frame>Up to 29 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with electrocardiogram (ECG) abnormalities</measure>
      <time_frame>Up to 29 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with clinical laboratory abnormalities</measure>
      <time_frame>Up to 29 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with physical examination abnormalities</measure>
      <time_frame>Up to 29 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to attain maximum observed plasma concentration (Tmax)</measure>
      <time_frame>Up to 15 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal half-life (T-Half)</measure>
      <time_frame>Up to 15 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))</measure>
      <time_frame>Up to 15 days</time_frame>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Treatment A: BMS-986419 DR Capsule - Fasted</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment B: BMS-986419 IR Tablet - Fasted</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment C: BMS-986419 IR Tablet - Fed</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment D: BMS-986419 Crushed IR Tablet - Fed</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BMS-986419 DR Capsule</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>Treatment A: BMS-986419 DR Capsule - Fasted</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BMS-986419 IR Tablet</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>Treatment B: BMS-986419 IR Tablet - Fasted</arm_group_label>
      <arm_group_label>Treatment C: BMS-986419 IR Tablet - Fed</arm_group_label>
      <arm_group_label>Treatment D: BMS-986419 Crushed IR Tablet - Fed</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy male and female participants without clinically significant deviation from&#xD;
               normal, as determined by the investigator, in medical history, physical examination,&#xD;
               vital signs, 12-lead ECG, and clinical laboratory evaluations.&#xD;
  &#xD;
            -  Body mass index (BMI) of 18.0 to 32.0 kilograms per meter squared (kg/m^2), inclusive,&#xD;
               and body weight ≥ 50 kg.&#xD;
  &#xD;
            -  A female participant is eligible to participate if she is a woman not of childbearing&#xD;
               potential (WNOCBP)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any significant acute or chronic medical illness (eg, history of intracranial or&#xD;
               intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etcetera)&#xD;
               as determined by the investigator.&#xD;
  &#xD;
            -  Current or recent (within 3 months of study intervention administration)&#xD;
               gastrointestinal disease that could affect the absorption, distribution, metabolism,&#xD;
               and excretion of study intervention (for example, bariatric procedure).&#xD;
  &#xD;
            -  History of Gilbert's syndrome.&#xD;
  &#xD;
            -  Women who are of childbearing potential and women who are breastfeeding.&#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>
    <location>
      <facility>
        <name>Anaheim Clinical Trials</name>
        <address>
          <city>Anaheim</city>
          <state>California</state>
          <zip>92801</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Amina Haggag, Site 0001</last_name>
        <phone>714-774-7777</phone>
      </contact>
    </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>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>BMS-986419</keyword>
    <keyword>Healthy male of non-child bearing potential</keyword>
    <keyword>Healthy women of non-child bearing potential</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-andpartners/ clinical-trials-andresearch/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/NCT05963932
  org study id: CN007-1001
  nct id: NCT05963932
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to assess the impact of the BMS-986419 new immediate release
        (IR) tablet formulation compared to the current enteric (DR) capsule formulation, and to
        assess the effect of food on the drug levels of the IR tablet formulation in healthy adult
        participants.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Maximum observed plasma concentration (Cmax)
  time frame: Up to 15 days
  measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
  time frame: Up to 15 days
  measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
  time frame: Up to 15 days
  measure: Number of participants with adverse events (AEs)
  time frame: Up to 29 days
  measure: Number of participants with vital sign abnormalities
  time frame: Up to 29 days
  measure: Number of participants with electrocardiogram (ECG) abnormalities
  time frame: Up to 29 days
  measure: Number of participants with clinical laboratory abnormalities
  time frame: Up to 29 days
  measure: Number of participants with physical examination abnormalities
  time frame: Up to 29 days
  measure: Time to attain maximum observed plasma concentration (Tmax)
  time frame: Up to 15 days
  measure: Terminal half-life (T-Half)
  time frame: Up to 15 days
  measure: Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))
  time frame: Up to 15 days
  arm group label: Treatment A: BMS-986419 DR Capsule - Fasted
  arm group type: Experimental
  arm group label: Treatment B: BMS-986419 IR Tablet - Fasted
  arm group type: Experimental
  arm group label: Treatment C: BMS-986419 IR Tablet - Fed
  arm group type: Experimental
  arm group label: Treatment D: BMS-986419 Crushed IR Tablet - Fed
  arm group type: Experimental
  intervention type: Drug
  intervention name: BMS-986419 DR Capsule
  description: Specified dose on specified days
  arm group label: Treatment A: BMS-986419 DR Capsule - Fasted
  intervention type: Drug
  intervention name: BMS-986419 IR Tablet
  description: Specified dose on specified days
  arm group label: Treatment B: BMS-986419 IR Tablet - Fasted
  arm group label: Treatment C: BMS-986419 IR Tablet - Fed
  arm group label: Treatment D: BMS-986419 Crushed IR Tablet - Fed
  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 #.
  facility: 
  status: Recruiting
  contact: 
  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
  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-andpartners/ clinical-trials-andresearch/disclosure-commitment.html