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/NCT05981963</url>
    </required_header>
    <id_info>
      <org_study_id>IM038-1007</org_study_id>
      <nct_id>NCT05981963</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants</brief_title>
    <official_title>A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of Orally Administered 60 mg BMS-986196, Including Radioactively Labeled [14C]-BMS-986196, in Healthy Male 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 evaluate the excretion pathway of orally administered&#xD;
        [14C]-BMS-986196 and to assess the safety and tolerability of orally administered BMS-986196.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 17, 2023</start_date>
    <completion_date type="Anticipated">October 22, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 22, 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Total Radioactivity (TRA): Maximum observed plasma concentration (Cmax)</measure>
      <time_frame>Up to Day 15</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>TRA: Time of Cmax (Tmax)</measure>
      <time_frame>Up to Day 15</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>TRA: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])</measure>
      <time_frame>Up to Day 15</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>TRA: Amount of radioactivity recovered in urine (UR)</measure>
      <time_frame>Up to Day 15</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>TRA: Amount of radioactivity recovered in feces (FR)</measure>
      <time_frame>Up to Day 15</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>TRA: Amount of radioactivity recovered in bile (BR)</measure>
      <time_frame>Up to 14 hours post dose</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>TRA: Percent of administered dose recovered in urine (%UR)</measure>
      <time_frame>Up to Day 15</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>TRA: Percent of administered dose recovered in feces (%FR)</measure>
      <time_frame>Up to Day 15</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total)</measure>
      <time_frame>Up to Day 15</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cmax</measure>
      <time_frame>Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax</measure>
      <time_frame>Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC (0-T)</measure>
      <time_frame>Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Adverse Events (AEs)</measure>
      <time_frame>Up to Day 29</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Serious AEs (SAEs)</measure>
      <time_frame>Up to Day 29</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with AEs Leading to Discontinuation</measure>
      <time_frame>Up to Day 29</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Vital Sign Abnormalities</measure>
      <time_frame>Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Electrocardiogram (ECG) Abnormalities</measure>
      <time_frame>Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Physical Examination Abnormalities</measure>
      <time_frame>Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Clinical Laboratory Abnormalities</measure>
      <time_frame>Up to Day 15</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">8</enrollment>
    <condition>Healthy Male Volunteers</condition>
    <arm_group>
      <arm_group_label>[14C]-BMS-986196</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>[14C]-BMS-986196</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>[14C]-BMS-986196</arm_group_label>
      <other_name>BMS-986196</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy male participants without clinically significant deviation from normal in&#xD;
               medical history, electrocardiogram (ECG), clinical laboratory determinations, and Day&#xD;
               -1 physical examination.&#xD;
  &#xD;
            -  Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m^2), inclusive, and total&#xD;
               body weight ≥ 50 kg&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any significant acute or chronic medical illness as determined by the investigator.&#xD;
  &#xD;
            -  A history of clinically significant hepatic or pancreatic disease (Gilbert's syndrome&#xD;
               is permissible).&#xD;
  &#xD;
            -  Current or recent (within 3 months prior to study treatment administration)&#xD;
               gastrointestinal disease that could impact upon the absorption, distribution,&#xD;
               metabolism, or excretion of study treatment as determined by the investigator.&#xD;
  &#xD;
          Note: Other protocol-defined inclusion/exclusion criteria apply.&#xD;
        </textblock>
      </criteria>
      <gender>Male</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>Labcorp Clinical Research Unit - Madison</name>
        <address>
          <city>Madison</city>
          <state>Wisconsin</state>
          <zip>53704-2526</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sarah Russell, Site 0001</last_name>
        <phone>608-210-5574</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Labcorp Clinical Research Unit - Madison</name>
        <address>
          <city>Madison</city>
          <state>Wisconsin</state>
          <zip>53704-2526</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sarah Fulham Russell, Site 0002</last_name>
        <phone>608-210-5574</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>http://www.BMSStudyConnect.com</url>
      <description>BMS Clinical Trial Patient Recruiting</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pharmacokinetics</keyword>
    <keyword>BMS-986196</keyword>
    <keyword>Healthy male volunteers</keyword>
    <keyword>[14C]-BMS-986196</keyword>
    <keyword>Total radioactivity</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/disclosurecommitment.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/NCT05981963
  org study id: IM038-1007
  nct id: NCT05981963
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate the excretion pathway of orally administered
        [14C]-BMS-986196 and to assess the safety and tolerability of orally administered BMS-986196.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Total Radioactivity (TRA): Maximum observed plasma concentration (Cmax)
  time frame: Up to Day 15
  measure: TRA: Time of Cmax (Tmax)
  time frame: Up to Day 15
  measure: TRA: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
  time frame: Up to Day 15
  measure: TRA: Amount of radioactivity recovered in urine (UR)
  time frame: Up to Day 15
  measure: TRA: Amount of radioactivity recovered in feces (FR)
  time frame: Up to Day 15
  measure: TRA: Amount of radioactivity recovered in bile (BR)
  time frame: Up to 14 hours post dose
  measure: TRA: Percent of administered dose recovered in urine (%UR)
  time frame: Up to Day 15
  measure: TRA: Percent of administered dose recovered in feces (%FR)
  time frame: Up to Day 15
  measure: TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total)
  time frame: Up to Day 15
  measure: Cmax
  time frame: Up to Day 15
  measure: Tmax
  time frame: Up to Day 15
  measure: AUC (0-T)
  time frame: Up to Day 15
  measure: Number of Participants with Adverse Events (AEs)
  time frame: Up to Day 29
  measure: Number of Participants with Serious AEs (SAEs)
  time frame: Up to Day 29
  measure: Number of Participants with AEs Leading to Discontinuation
  time frame: Up to Day 29
  measure: Number of Participants with Vital Sign Abnormalities
  time frame: Up to Day 15
  measure: Number of Participants with Electrocardiogram (ECG) Abnormalities
  time frame: Up to Day 15
  measure: Number of Participants with Physical Examination Abnormalities
  time frame: Up to Day 15
  measure: Number of Participants with Clinical Laboratory Abnormalities
  time frame: Up to Day 15
  arm group label: [14C]-BMS-986196
  arm group type: Experimental
  intervention type: Drug
  intervention name: [14C]-BMS-986196
  description: Specified dose on specified days
  arm group label: [14C]-BMS-986196
  other name: BMS-986196
  criteria: 
  gender: Male
  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: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: United States
  url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
  description: BMS Clinical Trial Information
  url: http://www.BMSStudyConnect.com
  description: BMS Clinical Trial Patient Recruiting
  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/disclosurecommitment.html