<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/NCT03035734</url>
  </required_header>
  <id_info>
    <org_study_id>CV006-023</org_study_id>
    <secondary_id>2016-001031-13</secondary_id>
    <nct_id>NCT03035734</nct_id>
  </id_info>
  <brief_title>Evaluate the Bioavailability Between 2 BMS-986141 Formulations in Healthy Participants</brief_title>
  <official_title>A Randomized Study to Evaluate the Bioavailability of BMS-986141 From a Form B Tablet Formulation Relative to the Form A Reference Tablet in Healthy 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to&#xD;
      healthy female subjects of non-childbearing potential and healthy males.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Business objectives have changed&#xD;
  </why_stopped>
  <start_date type="Actual">January 25, 2017</start_date>
  <completion_date type="Actual">February 7, 2017</completion_date>
  <primary_completion_date type="Actual">February 7, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Further characterize safety and tolerability of BMS-986141 by assessing adverse events and other physical assessments throughout study conduct</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single oral dose BMS-986141 Form A tablet under fasting conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose BMS-986141 Form B tablet (low-dose) under fasting conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose BMS-986141 Form B tablet (high-dose) under fasting conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose BMS-986141 Form B tablet (high-dose) under fed conditions</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986141 Form A Tablet</intervention_name>
    <description>tablet</description>
    <arm_group_label>A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986141 Form B tablet (low dose)</intervention_name>
    <description>tablet</description>
    <arm_group_label>B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986141 Form B tablet (high dose)</intervention_name>
    <description>tablet</description>
    <arm_group_label>C</arm_group_label>
    <arm_group_label>D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy participants as determined by no significant deviations in normal medical and&#xD;
             surgical history and assessments&#xD;
&#xD;
          -  Body mass index 18.0 kg/m2 to 32.0 kg/m2&#xD;
&#xD;
          -  females must be of non-childbearing potential&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known bleeding or coagulation disorders&#xD;
&#xD;
          -  acute or chronic medical illness&#xD;
&#xD;
          -  history of nausea or chronic diarrhea that lasts over 4 weeks&#xD;
&#xD;
          -  history of periodontal disease or gingivitis which required treatment&#xD;
&#xD;
          -  other exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</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>
  <link>
    <url>http://www.bms.com/studyconnect/pages/home.aspx</url>
    <description>BMS clinical trial educational resource</description>
  </link>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>March 21, 2018</last_update_submitted>
  <last_update_submitted_qc>March 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03035734
org study id: CV006-023
secondary id: 2016-001031-13
nct id: NCT03035734
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to
      healthy female subjects of non-childbearing potential and healthy males.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet
time frame: 4 weeks
measure: Further characterize safety and tolerability of BMS-986141 by assessing adverse events and other physical assessments throughout study conduct
time frame: 4 weeks
arm group label: A
arm group type: Active Comparator
description: Single oral dose BMS-986141 Form A tablet under fasting conditions
arm group label: B
arm group type: Experimental
description: Single oral dose BMS-986141 Form B tablet (low-dose) under fasting conditions
arm group label: C
arm group type: Experimental
description: Single oral dose BMS-986141 Form B tablet (high-dose) under fasting conditions
arm group label: D
arm group type: Experimental
description: Single oral dose BMS-986141 Form B tablet (high-dose) under fed conditions
intervention type: Drug
intervention name: BMS-986141 Form A Tablet
description: tablet
arm group label: A
intervention type: Drug
intervention name: BMS-986141 Form B tablet (low dose)
description: tablet
arm group label: B
intervention type: Drug
intervention name: BMS-986141 Form B tablet (high dose)
description: tablet
arm group label: C
arm group label: D
criteria: 
gender: All
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
url: http://www.bms.com/studyconnect/pages/home.aspx
description: BMS clinical trial educational resource
responsible party type: Sponsor