<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/NCT02257151</url>
  </required_header>
  <id_info>
    <org_study_id>IM006-001</org_study_id>
    <nct_id>NCT02257151</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects</brief_title>
  <official_title>Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, and Pharmacokinetics of BMS-986142 in Healthy 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety, pharmacokinetics, and target engagement&#xD;
      of BMS-986142 in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Allocation: Randomized Controlled Trial (SAD/MAD) Masking: Double-Blind (SAD/MAD)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after single dose of BMS-986142</measure>
    <time_frame>Single Ascending Dose(SAD) within 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after multiple doses of BMS-986142</measure>
    <time_frame>Multiple Ascending Dose (MAD) within 19 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Healthy Adult</condition>
  <arm_group>
    <arm_group_label>Group 1: BMS-986142 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986142 or placebo Single dose oral Solution or spray dried dispersion as specified</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: BMS-986142 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986142 or placebo Multiple dose oral Solution as specified</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986142</intervention_name>
    <arm_group_label>Group 1: BMS-986142 or placebo</arm_group_label>
    <arm_group_label>Group 2: BMS-986142 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Group 1: BMS-986142 or placebo</arm_group_label>
    <arm_group_label>Group 2: BMS-986142 or placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For more information regarding BMS clinical trial participation, please visit&#xD;
        www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male and female subjects as determined by no clinically significant deviation&#xD;
             from normal in medical history, physical examination, ECGs, and clinical laboratory&#xD;
             determinations&#xD;
&#xD;
          2. Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=weight (kg)/[height(m)]2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any significant acute or chronic medical illness&#xD;
&#xD;
          2. Current or recent (within 3 months of study drug administration) gastrointestinal&#xD;
             disease&#xD;
&#xD;
          3. Any major surgery within 4 weeks of study drug administration&#xD;
&#xD;
          4. Any gastrointestinal surgery that could impact upon the absorption of study drug&#xD;
&#xD;
          5. Donation of blood to a blood bank or in a clinical study (except a screening visit)&#xD;
             within 4 weeks of study drug administration (within 2 weeks for plasma only)&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Wcct Global, Llc</name>
      <address>
        <city>Cypress</city>
        <state>California</state>
        <zip>90630</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 educational resource</description>
  </link>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>September 22, 2015</last_update_submitted>
  <last_update_submitted_qc>September 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Volunteers</keyword>
  <!-- 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/NCT02257151
org study id: IM006-001
nct id: NCT02257151
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety, pharmacokinetics, and target engagement
      of BMS-986142 in healthy subjects.
Allocation: Randomized Controlled Trial (SAD/MAD) Masking: Double-Blind (SAD/MAD)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after single dose of BMS-986142
time frame: Single Ascending Dose(SAD) within 8 days
measure: Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after multiple doses of BMS-986142
time frame: Multiple Ascending Dose (MAD) within 19 days
arm group label: Group 1: BMS-986142 or placebo
arm group type: Experimental
description: BMS-986142 or placebo Single dose oral Solution or spray dried dispersion as specified
arm group label: Group 2: BMS-986142 or placebo
arm group type: Experimental
description: BMS-986142 or placebo Multiple dose oral Solution as specified
intervention type: Drug
intervention name: BMS-986142
arm group label: Group 1: BMS-986142 or placebo
arm group label: Group 2: BMS-986142 or placebo
intervention type: Drug
intervention name: Placebo
arm group label: Group 1: BMS-986142 or placebo
arm group label: Group 2: BMS-986142 or placebo
criteria: 
gender: All
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: United States
url: http://www.bms.com/studyconnect/Pages/home.aspx
description: BMS clinical trial educational resource
responsible party type: Sponsor