<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/NCT03245515</url>
  </required_header>
  <id_info>
    <org_study_id>IM014-016</org_study_id>
    <secondary_id>2017-002706-12</secondary_id>
    <nct_id>NCT03245515</nct_id>
  </id_info>
  <brief_title>A Study of BMS-986195 in Healthy Male Subjects</brief_title>
  <official_title>Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">October 5, 2017</completion_date>
  <primary_completion_date type="Actual">September 22, 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>Maximum observed plasma concentration (Cmax)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to attain maximum observed plasma concentration (tmax)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve up to time t, where t is the last point with concentrations above the lower limit of quantitation [AUC(t-0)]</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)]</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of estimated part for the calculation of AUC0-inf (%AUCextra)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal elimination rate constant (kel)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal elimination half life, calculated as 0.693/kel (t1/2)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent oral clearance, calculated as dose/AUC0-inf (CL/F)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution at terminal phase (Vz/F)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative amount of TRA excreted in urine (Aeurine)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative amount of TRA excreted in feces (Aefeces)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative amount of TRA excreted in bile (Aebile)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fraction of the dose administered excreted in urine (feurine)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fraction of the dose administered excreted in feces (fefeces)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fraction of the dose administered excreted in bile (febile)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fraction of the dose administered excreted in urine and feces (fetotal)</measure>
    <time_frame>Up to 16 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events (AE)</measure>
    <time_frame>Up to 16 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of serious adverse events (SAE)</measure>
    <time_frame>Up to 16 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of laboratory test result abnormalities</measure>
    <time_frame>Up to 16 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate measured by ECG</measure>
    <time_frame>Up to 16 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PR-interval measured by ECG</measure>
    <time_frame>Up to 16 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QRS-duration measured by ECG</measure>
    <time_frame>Up to 16 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QT-interval measured by ECG</measure>
    <time_frame>Up to 16 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QTc-interval (Fridericia's) measured by ECG</measure>
    <time_frame>Up to 16 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>BMS-986195</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single oral solution dose of BMS-986195</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986195</intervention_name>
    <description>specified dose on specified days</description>
    <arm_group_label>BMS-986195</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please&#xD;
        visit www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Male subjects, if not surgically sterilized, must agree to use adequate contraception&#xD;
&#xD;
          -  Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive (BMI = weight [kg]/[height&#xD;
             (m)]2), and total body weight &gt;50 kg&#xD;
&#xD;
          -  All prescribed medication, including live vaccinations, must have been stopped at&#xD;
             least 30 days prior to admission to the clinical research center&#xD;
&#xD;
          -  All over-the-counter (OTC ) medication, vitamin preparations and other food&#xD;
             supplements, or herbal medications (eg, St. John's Wort) must have been stopped at&#xD;
             least 14 days prior to admission to the clinical research center&#xD;
&#xD;
          -  Ability and willingness to abstain from alcohol, methylxanthine-containing beverages&#xD;
             or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 3&#xD;
             days prior to admission to the clinical research center&#xD;
&#xD;
          -  Good physical and mental health on the basis of medical history, physical examination,&#xD;
             clinical laboratory, ECG and vital signs, as judged by the Principal Investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous participation in the current study&#xD;
&#xD;
          -  Known previous exposure to BMS-986195&#xD;
&#xD;
          -  Employee of PRA or the Sponsor&#xD;
&#xD;
          -  History of relevant drug and/or food allergies, including allergy to immunologic or&#xD;
             related compounds or allergy to seafood or marine products&#xD;
&#xD;
          -  Using tobacco products within 60 days prior to drug administration&#xD;
&#xD;
          -  Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV)&#xD;
             antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could 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>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Groningen</city>
        <zip>9728 NZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://bms.com/studyconnect/Pages/home.aspx</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>January 3, 2018</last_update_submitted>
  <last_update_submitted_qc>January 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 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>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Branebrutinib</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/NCT03245515
org study id: IM014-016
secondary id: 2017-002706-12
nct id: NCT03245515
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum observed plasma concentration (Cmax)
time frame: Up to 16 days
measure: Time to attain maximum observed plasma concentration (tmax)
time frame: Up to 16 days
measure: Area under the plasma concentration-time curve up to time t, where t is the last point with concentrations above the lower limit of quantitation [AUC(t-0)]
time frame: Up to 16 days
measure: Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)]
time frame: Up to 16 days
measure: Percentage of estimated part for the calculation of AUC0-inf (%AUCextra)
time frame: Up to 16 days
measure: Terminal elimination rate constant (kel)
time frame: Up to 16 days
measure: Terminal elimination half life, calculated as 0.693/kel (t1/2)
time frame: Up to 16 days
measure: Apparent oral clearance, calculated as dose/AUC0-inf (CL/F)
time frame: Up to 16 days
measure: Apparent volume of distribution at terminal phase (Vz/F)
time frame: Up to 16 days
measure: Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%)
time frame: Up to 16 days
measure: Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)
time frame: Up to 16 days
measure: Cumulative amount of TRA excreted in urine (Aeurine)
time frame: Up to 16 days
measure: Cumulative amount of TRA excreted in feces (Aefeces)
time frame: Up to 16 days
measure: Cumulative amount of TRA excreted in bile (Aebile)
time frame: Up to 16 days
measure: Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces
time frame: Up to 16 days
measure: Fraction of the dose administered excreted in urine (feurine)
time frame: Up to 16 days
measure: Fraction of the dose administered excreted in feces (fefeces)
time frame: Up to 16 days
measure: Fraction of the dose administered excreted in bile (febile)
time frame: Up to 16 days
measure: Fraction of the dose administered excreted in urine and feces (fetotal)
time frame: Up to 16 days
measure: Number of adverse events (AE)
time frame: Up to 16 days
measure: Number of serious adverse events (SAE)
time frame: Up to 16 days
measure: Number of laboratory test result abnormalities
time frame: Up to 16 days
measure: Heart rate measured by ECG
time frame: Up to 16 days
measure: PR-interval measured by ECG
time frame: Up to 16 days
measure: QRS-duration measured by ECG
time frame: Up to 16 days
measure: QT-interval measured by ECG
time frame: Up to 16 days
measure: QTc-interval (Fridericia's) measured by ECG
time frame: Up to 16 days
arm group label: BMS-986195
arm group type: Experimental
description: A single oral solution dose of BMS-986195
intervention type: Drug
intervention name: BMS-986195
description: specified dose on specified days
arm group label: BMS-986195
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
facility: 
country: Netherlands
url: http://bms.com/studyconnect/Pages/home.aspx
description: BMS Clinical Trial Patient Recruiting
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Branebrutinib