<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/NCT04444050</url>
  </required_header>
  <id_info>
    <org_study_id>CV023-005</org_study_id>
    <nct_id>NCT04444050</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants</brief_title>
  <official_title>Randomized, Double-Blind, Placebo-Controlled Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986331 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>
    <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>
      The purpose of this study is to evaluate the safety, tolerability, drug levels and drug&#xD;
      effects of single and multiple oral doses of BMS-986331 versus placebo in healthy&#xD;
      participants and healthy Japanese participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Actual">May 19, 2021</completion_date>
  <primary_completion_date type="Actual">May 19, 2021</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>Sequential Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events (AEs)</measure>
    <time_frame>Up to 13 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with clinical laboratory abnormalities</measure>
    <time_frame>Up to 46 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with vital sign abnormalities</measure>
    <time_frame>Up to 46 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with electrocardiogram (ECG) abnormalities</measure>
    <time_frame>Up to 46 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>Up to 17 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach Cmax in plasma (Tmax)</measure>
    <time_frame>Up to 17 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed [AUC(0-T)]</measure>
    <time_frame>Up to 17 days</time_frame>
  </secondary_outcome>
  <number_of_arms>16</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>Part 1 Single Ascending Dose (SAD): Panel 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 SAD: Panel 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 SAD: Panel 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 SAD: Panel 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 SAD: Panel 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 SAD: Panel 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 SAD: Optional Split-dose Panel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Multiple Ascending Dose (MAD): Panel 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 MAD: Panel 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 MAD: Panel 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 MAD: Panel 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 MAD: Optional (to be determined) Panel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 3 MAD in Japanese Participants (J-MAD): Panel 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 3 J-MAD: Panel 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 3 J-MAD: Panel 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 3 J-MAD: Optional (to be determined) Panel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986331</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Part 1 SAD: Optional Split-dose Panel</arm_group_label>
    <arm_group_label>Part 1 SAD: Panel 2</arm_group_label>
    <arm_group_label>Part 1 SAD: Panel 3</arm_group_label>
    <arm_group_label>Part 1 SAD: Panel 4</arm_group_label>
    <arm_group_label>Part 1 SAD: Panel 5</arm_group_label>
    <arm_group_label>Part 1 SAD: Panel 6</arm_group_label>
    <arm_group_label>Part 1 Single Ascending Dose (SAD): Panel 1</arm_group_label>
    <arm_group_label>Part 2 MAD: Optional (to be determined) Panel</arm_group_label>
    <arm_group_label>Part 2 MAD: Panel 2</arm_group_label>
    <arm_group_label>Part 2 MAD: Panel 3</arm_group_label>
    <arm_group_label>Part 2 MAD: Panel 4</arm_group_label>
    <arm_group_label>Part 2 Multiple Ascending Dose (MAD): Panel 1</arm_group_label>
    <arm_group_label>Part 3 J-MAD: Optional (to be determined) Panel</arm_group_label>
    <arm_group_label>Part 3 J-MAD: Panel 2</arm_group_label>
    <arm_group_label>Part 3 J-MAD: Panel 3</arm_group_label>
    <arm_group_label>Part 3 MAD in Japanese Participants (J-MAD): Panel 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo, Matching BMS-986331</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Part 1 SAD: Optional Split-dose Panel</arm_group_label>
    <arm_group_label>Part 1 SAD: Panel 2</arm_group_label>
    <arm_group_label>Part 1 SAD: Panel 3</arm_group_label>
    <arm_group_label>Part 1 SAD: Panel 4</arm_group_label>
    <arm_group_label>Part 1 SAD: Panel 5</arm_group_label>
    <arm_group_label>Part 1 SAD: Panel 6</arm_group_label>
    <arm_group_label>Part 1 Single Ascending Dose (SAD): Panel 1</arm_group_label>
    <arm_group_label>Part 2 MAD: Optional (to be determined) Panel</arm_group_label>
    <arm_group_label>Part 2 MAD: Panel 2</arm_group_label>
    <arm_group_label>Part 2 MAD: Panel 3</arm_group_label>
    <arm_group_label>Part 2 MAD: Panel 4</arm_group_label>
    <arm_group_label>Part 2 Multiple Ascending Dose (MAD): Panel 1</arm_group_label>
    <arm_group_label>Part 3 J-MAD: Optional (to be determined) Panel</arm_group_label>
    <arm_group_label>Part 3 J-MAD: Panel 2</arm_group_label>
    <arm_group_label>Part 3 J-MAD: Panel 3</arm_group_label>
    <arm_group_label>Part 3 MAD in Japanese Participants (J-MAD): Panel 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No clinically significant deviations in medical history, physical examination, ECGs,&#xD;
             vital signs, and clinical laboratory determinations&#xD;
&#xD;
          -  A body mass index of 18 - 32 kg/m2, inclusive&#xD;
&#xD;
          -  Women and men must agree to follow specific methods of contraception, if applicable&#xD;
&#xD;
        For J-MAD Part 3&#xD;
&#xD;
          -  Must be Japanese (both biological parents are ethnically Japanese)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are of childbearing potential&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding&#xD;
&#xD;
          -  Any significant acute or chronic medical illness&#xD;
&#xD;
          -  Current or recent (within 3 months of study drug administration) gastrointestinal&#xD;
             disease that could impact upon the absorption of study drug&#xD;
&#xD;
          -  Any surgery within 12 weeks of study drug administration&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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 - 0001</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICON (LPRA) - Lenexa</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>Investigator Inquiry Form</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>October 19, 2022</last_update_submitted>
  <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy participants</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/NCT04444050
org study id: CV023-005
nct id: NCT04444050
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety, tolerability, drug levels and drug
      effects of single and multiple oral doses of BMS-986331 versus placebo in healthy
      participants and healthy Japanese participants.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of participants with adverse events (AEs)
time frame: Up to 13 months
measure: Number of participants with clinical laboratory abnormalities
time frame: Up to 46 days
measure: Number of participants with vital sign abnormalities
time frame: Up to 46 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
time frame: Up to 46 days
measure: Maximum plasma concentration (Cmax)
time frame: Up to 17 days
measure: Time to reach Cmax in plasma (Tmax)
time frame: Up to 17 days
measure: Area under the plasma concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed [AUC(0-T)]
time frame: Up to 17 days
arm group label: Part 1 Single Ascending Dose (SAD): Panel 1
arm group type: Experimental
arm group label: Part 1 SAD: Panel 2
arm group type: Experimental
arm group label: Part 1 SAD: Panel 3
arm group type: Experimental
arm group label: Part 1 SAD: Panel 4
arm group type: Experimental
arm group label: Part 1 SAD: Panel 5
arm group type: Experimental
arm group label: Part 1 SAD: Panel 6
arm group type: Experimental
arm group label: Part 1 SAD: Optional Split-dose Panel
arm group type: Experimental
arm group label: Part 2 Multiple Ascending Dose (MAD): Panel 1
arm group type: Experimental
arm group label: Part 2 MAD: Panel 2
arm group type: Experimental
arm group label: Part 2 MAD: Panel 3
arm group type: Experimental
arm group label: Part 2 MAD: Panel 4
arm group type: Experimental
arm group label: Part 2 MAD: Optional (to be determined) Panel
arm group type: Experimental
arm group label: Part 3 MAD in Japanese Participants (J-MAD): Panel 1
arm group type: Experimental
arm group label: Part 3 J-MAD: Panel 2
arm group type: Experimental
arm group label: Part 3 J-MAD: Panel 3
arm group type: Experimental
arm group label: Part 3 J-MAD: Optional (to be determined) Panel
arm group type: Experimental
intervention type: Drug
intervention name: BMS-986331
description: Specified dose on specified days
arm group label: Part 1 SAD: Optional Split-dose Panel
arm group label: Part 1 SAD: Panel 2
arm group label: Part 1 SAD: Panel 3
arm group label: Part 1 SAD: Panel 4
arm group label: Part 1 SAD: Panel 5
arm group label: Part 1 SAD: Panel 6
arm group label: Part 1 Single Ascending Dose (SAD): Panel 1
arm group label: Part 2 MAD: Optional (to be determined) Panel
arm group label: Part 2 MAD: Panel 2
arm group label: Part 2 MAD: Panel 3
arm group label: Part 2 MAD: Panel 4
arm group label: Part 2 Multiple Ascending Dose (MAD): Panel 1
arm group label: Part 3 J-MAD: Optional (to be determined) Panel
arm group label: Part 3 J-MAD: Panel 2
arm group label: Part 3 J-MAD: Panel 3
arm group label: Part 3 MAD in Japanese Participants (J-MAD): Panel 1
intervention type: Other
intervention name: Placebo, Matching BMS-986331
description: Specified dose on specified days
arm group label: Part 1 SAD: Optional Split-dose Panel
arm group label: Part 1 SAD: Panel 2
arm group label: Part 1 SAD: Panel 3
arm group label: Part 1 SAD: Panel 4
arm group label: Part 1 SAD: Panel 5
arm group label: Part 1 SAD: Panel 6
arm group label: Part 1 Single Ascending Dose (SAD): Panel 1
arm group label: Part 2 MAD: Optional (to be determined) Panel
arm group label: Part 2 MAD: Panel 2
arm group label: Part 2 MAD: Panel 3
arm group label: Part 2 MAD: Panel 4
arm group label: Part 2 Multiple Ascending Dose (MAD): Panel 1
arm group label: Part 3 J-MAD: Optional (to be determined) Panel
arm group label: Part 3 J-MAD: Panel 2
arm group label: Part 3 J-MAD: Panel 3
arm group label: Part 3 MAD in Japanese Participants (J-MAD): Panel 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
facility: 
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: Investigator Inquiry Form
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor