<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/NCT03247283</url>
  </required_header>
  <id_info>
    <org_study_id>CA017-052A</org_study_id>
    <nct_id>NCT03247283</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Metabolism Study in Healthy Male Participants</brief_title>
  <official_title>Pharmacokinetics and Metabolism of [14C] BMS-986205 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>
      Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 19, 2017</start_date>
  <completion_date type="Actual">October 15, 2017</completion_date>
  <primary_completion_date type="Actual">October 15, 2017</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Measured by plasma concentrations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of Total Radioactivity Recovered in All Excreta (% total)</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Half-Life (T-HALF)</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Measured by plasma concentrations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Body Clearance (CLT)</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Measured by plasma concentrations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of Distribution during Terminal Elimination Phase (Vz/F)</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Measured by plasma concentrations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Maximum Observed Concentration (Tmax)</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Measured by plasma concentrations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Measured by investigator assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Results of electrocardiogram tests (ECGs)</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Measured by investigator assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Results of vital sign measurements</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Measured by investigator assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Results of clinical laboratory tests</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Measured by investigator assessment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Single Oral Dose of BMS-986205</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986205</intervention_name>
    <description>Carbon 14 tagged BMS-986205</description>
    <arm_group_label>Single Oral Dose of BMS-986205</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body weight 75-95kg, BMI 18.0-32.0 kg/m^2&#xD;
&#xD;
          -  Refrain from sperm donation 110 days after dosing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or recent gastrointestinal disease&#xD;
&#xD;
          -  Any GI surgery that could impact drug absorption&#xD;
&#xD;
          -  Active, known, or suspected autoimmune disease&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could apply&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Male inclusion only</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol- Myers Squibb</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Unit, Inc.</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.bms.com/studyconnect/pages/home.aspx</url>
    <description>BMS Clinical Trial Education Resource</description>
  </link>
  <link>
    <url>http://www.fda.gov/Safety/Recalls/</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>October 31, 2017</last_update_submitted>
  <last_update_submitted_qc>October 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</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>Linrodostat</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03247283
org study id: CA017-052A
nct id: NCT03247283
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
time frame: up to 28 days
description: Measured by plasma concentrations
measure: Percent of Total Radioactivity Recovered in All Excreta (% total)
time frame: up to 28 days
description: Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts
measure: Half-Life (T-HALF)
time frame: up to 28 days
description: Measured by plasma concentrations
measure: Total Body Clearance (CLT)
time frame: up to 28 days
description: Measured by plasma concentrations
measure: Volume of Distribution during Terminal Elimination Phase (Vz/F)
time frame: up to 28 days
description: Measured by plasma concentrations
measure: Time to Maximum Observed Concentration (Tmax)
time frame: up to 28 days
description: Measured by plasma concentrations
measure: Incidence of adverse events (AEs)
time frame: up to 28 days
description: Measured by investigator assessment
measure: Results of electrocardiogram tests (ECGs)
time frame: up to 28 days
description: Measured by investigator assessment
measure: Results of vital sign measurements
time frame: up to 28 days
description: Measured by investigator assessment
measure: Results of clinical laboratory tests
time frame: up to 28 days
description: Measured by investigator assessment
arm group label: Single Oral Dose of BMS-986205
arm group type: Experimental
intervention type: Drug
intervention name: BMS-986205
description: Carbon 14 tagged BMS-986205
arm group label: Single Oral Dose of BMS-986205
criteria: 
gender: Male
gender based: Yes
gender description: Male inclusion only
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bristol- Myers Squibb
role: Principal Investigator
affiliation: Bristol-Myers Squibb
facility: 
country: United States
url: http://www.bms.com/studyconnect/pages/home.aspx
description: BMS Clinical Trial Education Resource
url: http://www.fda.gov/Safety/Recalls/
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Linrodostat
sharing ipd: No