<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/NCT04493567</url>
  </required_header>
  <id_info>
    <org_study_id>MB130-101</org_study_id>
    <nct_id>NCT04493567</nct_id>
  </id_info>
  <brief_title>Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe</brief_title>
  <official_title>An Open-label, Randomized, Two-period Cross-over Study to Investigate the Relative Bioavailability of BMS-986036 in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe</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 develop an auto-injector (AI) device for the BMS-986036&#xD;
      subcutaneous formulation that can be self-administered conveniently by participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Actual">June 11, 2021</completion_date>
  <primary_completion_date type="Actual">June 11, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum observed serum concentration (Cmax)</measure>
    <time_frame>Up to 29 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]</measure>
    <time_frame>Up to 29 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036</measure>
    <time_frame>Up to 29 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>Up to 115 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in clinical laboratory results: Hematology tests</measure>
    <time_frame>Up to 85 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests</measure>
    <time_frame>Up to 85 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests</measure>
    <time_frame>Up to 85 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in vital signs: Body temperature</measure>
    <time_frame>Up to 85 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in vital signs: Respiratory rate</measure>
    <time_frame>Up to 85 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in vital signs: Blood pressure</measure>
    <time_frame>Up to 85 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in vital signs: Heart rate</measure>
    <time_frame>Up to 85 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval</measure>
    <time_frame>Up to 85 days</time_frame>
    <description>The PR interval is the time from the onset of the P wave to the start of the QRS complex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval</measure>
    <time_frame>Up to 85 days</time_frame>
    <description>QRS interval: A combination of the Q wave, R wave and S wave, the &quot;QRS complex&quot; represents ventricular depolarization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval</measure>
    <time_frame>Up to 85 days</time_frame>
    <description>The QT interval on the ECG is measured from the beginning of the QRS complex to the end of the T wave</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval</measure>
    <time_frame>Up to 85 days</time_frame>
    <description>Corrected QT interval using Fridericia's formula (QTcF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in physical examination findings</measure>
    <time_frame>Up to 85 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with local injection site reactions</measure>
    <time_frame>Up to 57 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Antibodies to fibroblast growth factor 21 (FGF21)</measure>
    <time_frame>Up to 57 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Antibodies to BMS-986036</measure>
    <time_frame>Up to 57 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986036</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe</arm_group_label>
    <arm_group_label>Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe</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;
          -  Healthy, overweight, obese, male and female participants, as determined by normal in&#xD;
             medical history, physical examination (PE), electrocardiograms (ECGs), and clinical&#xD;
             laboratory determinations&#xD;
&#xD;
          -  Body mass index (BMI) of 25.0 kg/m2 to 40.0 kg/m2, inclusive i) Approximately 25% of&#xD;
             participants will be overweight and have a BMI between 25 kg/m2 and 30 kg/m2,&#xD;
             inclusive ii) Approximately 75% of participants will be obese and have a BMI &gt; 30&#xD;
             kg/m2 to ≤ 40 kg/m2&#xD;
&#xD;
          -  Women and men must agree to follow specific methods of contraception, if applicable,&#xD;
             while participating in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding&#xD;
&#xD;
          -  Inability to tolerate subcutaneous (SC) injections&#xD;
&#xD;
          -  Inability to be venipunctured and/or tolerate venous access&#xD;
&#xD;
          -  Any sound medical, psychiatric, and/or social reason as determined by the investigator&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#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>Anaheim Clinical Trials</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICON (LPRA) - Salt Lake</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</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>March 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2022</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>Overweight</mesh_term>
  </condition_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/NCT04493567
org study id: MB130-101
nct id: NCT04493567
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to develop an auto-injector (AI) device for the BMS-986036
      subcutaneous formulation that can be self-administered conveniently by participants.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum observed serum concentration (Cmax)
time frame: Up to 29 days
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
time frame: Up to 29 days
measure: Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036
time frame: Up to 29 days
measure: Incidence of adverse events (AEs)
time frame: Up to 115 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
time frame: Up to 85 days
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
time frame: Up to 85 days
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
time frame: Up to 85 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
time frame: Up to 85 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
time frame: Up to 85 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
time frame: Up to 85 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
time frame: Up to 85 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
time frame: Up to 85 days
description: The PR interval is the time from the onset of the P wave to the start of the QRS complex.
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
time frame: Up to 85 days
description: QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
time frame: Up to 85 days
description: The QT interval on the ECG is measured from the beginning of the QRS complex to the end of the T wave
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
time frame: Up to 85 days
description: Corrected QT interval using Fridericia's formula (QTcF)
measure: Incidence of clinically significant changes in physical examination findings
time frame: Up to 85 days
measure: Number of participants with local injection site reactions
time frame: Up to 57 days
measure: Number of participants with Antibodies to fibroblast growth factor 21 (FGF21)
time frame: Up to 57 days
measure: Number of participants with Antibodies to BMS-986036
time frame: Up to 57 days
arm group label: Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe
arm group type: Experimental
arm group label: Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe
arm group type: Experimental
intervention type: Drug
intervention name: BMS-986036
description: Specified dose on specified days
arm group label: Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe
arm group label: Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe
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: 
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
mesh term: Overweight