<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/NCT03004768</url>
  </required_header>
  <id_info>
    <org_study_id>IM011-016</org_study_id>
    <nct_id>NCT03004768</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants</brief_title>
  <official_title>Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Covance</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An oral dose in healthy subjects to obtain information about the absorption, metabolism, and&#xD;
      excretion (AME) of BMS-986165&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 26, 2017</start_date>
  <completion_date type="Actual">February 27, 2017</completion_date>
  <primary_completion_date type="Actual">February 27, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary endpoint is PK exposure that will be determined from plasma concentration versus time</measure>
    <time_frame>Day 1 to Day 13</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary/fecal TRA (Total radioactivity) recovery data</measure>
    <time_frame>Day 1 to Day 13</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK terminal elimination half-life data (T-HALF)</measure>
    <time_frame>Day 1 to Day 13</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK apparent total body clearance (CL/F)</measure>
    <time_frame>Day 1 to Day 13</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK apparent volume of distribution (Vz/F)</measure>
    <time_frame>Day 1 to Day 13</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK time of maximum observed plasma concentration (Tmax)</measure>
    <time_frame>Day 1 to Day 13</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety endpoints include the incidence of adverse events (AEs)</measure>
    <time_frame>Day 1 to Day 13</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety endpoints include the results of electrocardiogram tests (ECGs)</measure>
    <time_frame>Day 1 to Day 13</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety endpoints include the results of vital signs</measure>
    <time_frame>Day 1 to Day 13</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety endpoints include the results of physical exams</measure>
    <time_frame>Day 1 to Day 13</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety endpoints include the results of clinical laboratory tests</measure>
    <time_frame>Day 1 to Day 13</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Single dose of radiolabeled BMS-986165</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986165</intervention_name>
    <description>Oral solution dose of 24 mg [14C] BMS-986165 containing approximately 100 micro Ci of TRA</description>
    <arm_group_label>Single dose of radiolabeled BMS-986165</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed Informed Consent&#xD;
&#xD;
          -  Target population: Healthy males with no clinically significant deviations from normal&#xD;
             in medical history, physical examinations, vital signs, electrocardiograms (ECGs),&#xD;
             physical measurements, and clinical laboratory tests&#xD;
&#xD;
          -  Body weight of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to&#xD;
             32 kg/m2.&#xD;
&#xD;
          -  No evidence of acute infection or other significant problem as determined from a&#xD;
             review of a chest x-ray, medical history, and physical examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any chronic or acute illness including active TB in the last 3 years,&#xD;
             recent infection, gastrointestinal disease, smoking within less than 6 months prior to&#xD;
             dosing, alcohol abuse, inability to tolerate oral medication, or inability to be&#xD;
             venipunctured.&#xD;
&#xD;
          -  Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first&#xD;
             dose of study drug, during the course of the study&#xD;
&#xD;
          -  Evidence of organ dysfunction or any clinically significant deviation from normal in&#xD;
             physical examination, vital signs, electrocardiograms, or clinical laboratory&#xD;
             determinations beyond what is consistent with the target population.&#xD;
&#xD;
          -  Participant with greater than Grade 2 acne.&#xD;
&#xD;
          -  Participated in a radiolabeled drug study within the previous 12 months; clinically&#xD;
             significant diagnostic or therapeutic radiation exposure within the previous 12&#xD;
             months; or current employment in a job requiring radiation exposure monitoring.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <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>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Madison Clinical Research Unit</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>February 2018</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>February 8, 2018</last_update_submitted>
  <last_update_submitted_qc>February 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deucravacitinib</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/NCT03004768
org study id: IM011-016
nct id: NCT03004768
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
An oral dose in healthy subjects to obtain information about the absorption, metabolism, and
      excretion (AME) of BMS-986165
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary endpoint is PK exposure that will be determined from plasma concentration versus time
time frame: Day 1 to Day 13
measure: Urinary/fecal TRA (Total radioactivity) recovery data
time frame: Day 1 to Day 13
measure: PK terminal elimination half-life data (T-HALF)
time frame: Day 1 to Day 13
measure: PK apparent total body clearance (CL/F)
time frame: Day 1 to Day 13
measure: PK apparent volume of distribution (Vz/F)
time frame: Day 1 to Day 13
measure: PK time of maximum observed plasma concentration (Tmax)
time frame: Day 1 to Day 13
measure: Safety endpoints include the incidence of adverse events (AEs)
time frame: Day 1 to Day 13
measure: Safety endpoints include the results of electrocardiogram tests (ECGs)
time frame: Day 1 to Day 13
measure: Safety endpoints include the results of vital signs
time frame: Day 1 to Day 13
measure: Safety endpoints include the results of physical exams
time frame: Day 1 to Day 13
measure: Safety endpoints include the results of clinical laboratory tests
time frame: Day 1 to Day 13
arm group label: Single dose of radiolabeled BMS-986165
arm group type: Experimental
intervention type: Drug
intervention name: BMS-986165
description: Oral solution dose of 24 mg [14C] BMS-986165 containing approximately 100 micro Ci of TRA
arm group label: Single dose of radiolabeled BMS-986165
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bristol-Myers Squibb
role: Study Director
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: Psoriasis
mesh term: Deucravacitinib