<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/NCT03751228</url>
  </required_header>
  <id_info>
    <org_study_id>IM011-068</org_study_id>
    <nct_id>NCT03751228</nct_id>
  </id_info>
  <brief_title>A Taste Assessment of BMS-986165 in Healthy Participants</brief_title>
  <official_title>An Open-Label Taste Assessment of BMS-986165 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 assess the taste characteristics of BMS-986165 formulations,&#xD;
      alone and mixed, in order to develop a pediatric oral form of BMS-986165.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2018</start_date>
  <completion_date type="Actual">November 26, 2018</completion_date>
  <primary_completion_date type="Actual">November 26, 2018</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>Taste properties of BMS-986165 alone &amp; in prototypes to determine Aromatic identity will be measured using the Flavor Profile of the Flavor Leadership Criteria</measure>
    <time_frame>Approximately 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Taste properties of BMS-986165 alone &amp; in prototypes to determine amplitude will be measured using the Flavor Profile of the Flavor Leadership Criteria</measure>
    <time_frame>Approximately 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Taste properties of BMS-986165 alone &amp; in prototypes to determine mouth-feel will be measured using the Flavor Profile of the Flavor Leadership Criteria</measure>
    <time_frame>Approximately 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Taste properties of BMS-986165 alone &amp; in prototypes to determine off-notes will be measured using the Flavor Profile of the Flavor Leadership Criteria</measure>
    <time_frame>Approximately 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Taste properties of BMS-986165 alone &amp; in prototypes to determine aftertaste will be measured using the Flavor Profile of the Flavor Leadership Criteria</measure>
    <time_frame>Approximately 2 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>BMS-986165 taste evaluation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986165 taste evaluation using Active Pharmaceutical Ingredient (API) and Prototypes of the API containing various flavors and sweeteners</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986165</intervention_name>
    <description>Swish and expectorate after tasting</description>
    <arm_group_label>BMS-986165 taste evaluation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Active Pharmaceutical Ingredient</intervention_name>
    <description>Swish and expectorate after tasting</description>
    <arm_group_label>BMS-986165 taste evaluation</arm_group_label>
    <other_name>API</other_name>
  </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;
          -  WOCBP must agree to follow instructions for method(s) of contraception for 5&#xD;
             half-lives of BMS-986165 (2 days) plus 30 days (duration of ovulatory cycle) for a&#xD;
             total of 32 days after each tasting day.&#xD;
&#xD;
          -  Males who are sexually active with WOCBP must agree to follow instructions for&#xD;
             method(s) of contraception 5 half-lives of the study drug (2 days) after each tasting&#xD;
             day.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A known sensitivity to BMS-986165&#xD;
&#xD;
          -  A history of any illness that, in the opinion of the investigator, might confound the&#xD;
             results of the study or pose an additional risk in administering study drug(s) to the&#xD;
             participant. This may include but is not limited to: a history of relevant drug or&#xD;
             food allergies; history of cardiovascular or central nervous system disease; history&#xD;
             or presence of clinically significant pathology; or history of mental disease&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>80 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>Senopsys</name>
      <address>
        <city>Woburn</city>
        <state>Massachusetts</state>
        <zip>01801</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.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 6, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>September 27, 2019</last_update_submitted>
  <last_update_submitted_qc>September 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deucravacitinib</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/NCT03751228
org study id: IM011-068
nct id: NCT03751228
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the taste characteristics of BMS-986165 formulations,
      alone and mixed, in order to develop a pediatric oral form of BMS-986165.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Taste properties of BMS-986165 alone & in prototypes to determine Aromatic identity will be measured using the Flavor Profile of the Flavor Leadership Criteria
time frame: Approximately 2 years
measure: Taste properties of BMS-986165 alone & in prototypes to determine amplitude will be measured using the Flavor Profile of the Flavor Leadership Criteria
time frame: Approximately 2 years
measure: Taste properties of BMS-986165 alone & in prototypes to determine mouth-feel will be measured using the Flavor Profile of the Flavor Leadership Criteria
time frame: Approximately 2 years
measure: Taste properties of BMS-986165 alone & in prototypes to determine off-notes will be measured using the Flavor Profile of the Flavor Leadership Criteria
time frame: Approximately 2 years
measure: Taste properties of BMS-986165 alone & in prototypes to determine aftertaste will be measured using the Flavor Profile of the Flavor Leadership Criteria
time frame: Approximately 2 years
arm group label: BMS-986165 taste evaluation
arm group type: Experimental
description: BMS-986165 taste evaluation using Active Pharmaceutical Ingredient (API) and Prototypes of the API containing various flavors and sweeteners
intervention type: Drug
intervention name: BMS-986165
description: Swish and expectorate after tasting
arm group label: BMS-986165 taste evaluation
intervention type: Drug
intervention name: Active Pharmaceutical Ingredient
description: Swish and expectorate after tasting
arm group label: BMS-986165 taste evaluation
other name: API
criteria: 
gender: All
minimum age: 25 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Deucravacitinib