<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/NCT03254784</url>
  </required_header>
  <id_info>
    <org_study_id>IM011-031</org_study_id>
    <nct_id>NCT03254784</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation</brief_title>
  <official_title>A Phase 1, Randomized, Open-Label, Single-Dose, Crossover Study To Evaluate the Bioavailability of BMS-986165 Tablet Formulation Relative To BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal And Increased Gastric pH on the Bioavailability of BMS-986165 Tablet Formulation 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>
    <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 BMS-986165 tablet formulation versus BMS-986165&#xD;
      capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie&#xD;
      meal and increased gastric pH on the BMS-986165 tablet formulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2017</start_date>
  <completion_date type="Actual">November 15, 2017</completion_date>
  <primary_completion_date type="Actual">November 4, 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>Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration [AUC(0-T)] derived from plasma concentration versus time</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events measured by incidence</measure>
    <time_frame>26 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events measured by incidence</measure>
    <time_frame>Approximately 55 days</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <condition>Arthritic Psoriasis</condition>
  <condition>Psoriasis</condition>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Tablet-Capsule Crossover 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tablet-Capsule Crossover 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tablet-Capsule Crossover 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tablet-Capsule Crossover 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tablet-Capsule Crossover 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tablet-Capsule Crossover 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986165 Capsule</intervention_name>
    <description>Oral capsule</description>
    <arm_group_label>Tablet-Capsule Crossover 1</arm_group_label>
    <arm_group_label>Tablet-Capsule Crossover 2</arm_group_label>
    <arm_group_label>Tablet-Capsule Crossover 3</arm_group_label>
    <arm_group_label>Tablet-Capsule Crossover 4</arm_group_label>
    <arm_group_label>Tablet-Capsule Crossover 5</arm_group_label>
    <arm_group_label>Tablet-Capsule Crossover 6</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986165 Tablet</intervention_name>
    <description>Oral tablet</description>
    <arm_group_label>Tablet-Capsule Crossover 1</arm_group_label>
    <arm_group_label>Tablet-Capsule Crossover 2</arm_group_label>
    <arm_group_label>Tablet-Capsule Crossover 3</arm_group_label>
    <arm_group_label>Tablet-Capsule Crossover 4</arm_group_label>
    <arm_group_label>Tablet-Capsule Crossover 5</arm_group_label>
    <arm_group_label>Tablet-Capsule Crossover 6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be willing and able to complete all study-specific procedures and visits&#xD;
&#xD;
          -  Healthy patients, as determined by no clinically significant deviation from normal in&#xD;
             medical history, physical examination, electrocardiogram, and clinical laboratory&#xD;
             determinations&#xD;
&#xD;
          -  Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening&#xD;
&#xD;
          -  Normal renal function at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women of childbearing potential not using an effective contraceptive method or are&#xD;
             breastfeeding&#xD;
&#xD;
          -  Any significant acute or chronic medical illness&#xD;
&#xD;
          -  History of chronic headaches, defined as occurring 15 days or more a month, over the&#xD;
             previous 3 months&#xD;
&#xD;
          -  History of headaches related to caffeine withdrawal, including energy drinks&#xD;
&#xD;
          -  History of syncope, orthostatic instability, or recurrent dizziness&#xD;
&#xD;
          -  Active TB requiring treatment or documented latent TB within the previous 3 years&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could 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>
  <location>
    <facility>
      <name>PRA Health Sciences</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>
  <removed_countries>
    <country>Netherlands</country>
  </removed_countries>
  <link>
    <url>http://bms.com/studyconnect/Pages/home.aspx</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>February 24, 2020</last_update_submitted>
  <last_update_submitted_qc>February 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</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>Arthritis, Psoriatic</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <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/NCT03254784
org study id: IM011-031
nct id: NCT03254784
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165
      capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie
      meal and increased gastric pH on the BMS-986165 tablet formulation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time
time frame: 5 days
measure: AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time
time frame: 5 days
measure: Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration [AUC(0-T)] derived from plasma concentration versus time
time frame: 5 days
measure: Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time
time frame: 5 days
measure: Adverse events measured by incidence
time frame: 26 days
measure: Serious adverse events measured by incidence
time frame: Approximately 55 days
arm group label: Tablet-Capsule Crossover 1
arm group type: Experimental
description: Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
arm group label: Tablet-Capsule Crossover 2
arm group type: Experimental
description: Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
arm group label: Tablet-Capsule Crossover 3
arm group type: Experimental
description: Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
arm group label: Tablet-Capsule Crossover 4
arm group type: Experimental
description: Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
arm group label: Tablet-Capsule Crossover 5
arm group type: Experimental
description: Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
arm group label: Tablet-Capsule Crossover 6
arm group type: Experimental
description: Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
intervention type: Drug
intervention name: BMS-986165 Capsule
description: Oral capsule
arm group label: Tablet-Capsule Crossover 1
arm group label: Tablet-Capsule Crossover 2
arm group label: Tablet-Capsule Crossover 3
arm group label: Tablet-Capsule Crossover 4
arm group label: Tablet-Capsule Crossover 5
arm group label: Tablet-Capsule Crossover 6
intervention type: Drug
intervention name: BMS-986165 Tablet
description: Oral tablet
arm group label: Tablet-Capsule Crossover 1
arm group label: Tablet-Capsule Crossover 2
arm group label: Tablet-Capsule Crossover 3
arm group label: Tablet-Capsule Crossover 4
arm group label: Tablet-Capsule Crossover 5
arm group label: Tablet-Capsule Crossover 6
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
facility: 
country: United States
country: Netherlands
url: http://bms.com/studyconnect/Pages/home.aspx
description: BMS Clinical Trial Patient Recruiting
responsible party type: Sponsor
mesh term: Arthritis, Psoriatic
mesh term: Inflammatory Bowel Diseases
mesh term: Psoriasis
mesh term: Lupus Erythematosus, Systemic
mesh term: Deucravacitinib