<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/NCT03038711</url>
  </required_header>
  <id_info>
    <org_study_id>IM018-003</org_study_id>
    <nct_id>NCT03038711</nct_id>
  </id_info>
  <brief_title>A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers</brief_title>
  <official_title>A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 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 understand if multiple oral doses of BMS-986166 are safe and&#xD;
      well tolerated in healthy patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">August 10, 2017</completion_date>
  <primary_completion_date type="Actual">August 10, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of All Adverse Events (AEs)</measure>
    <time_frame>77 days</time_frame>
    <description>measured by number of patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Serious Adverse Events (SAEs)</measure>
    <time_frame>77 days</time_frame>
    <description>measured by number of patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of all Adverse Events (AEs)</measure>
    <time_frame>77 days</time_frame>
    <description>measured by investigator</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in physical examination findings</measure>
    <time_frame>77 days</time_frame>
    <description>measured by investigator</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in electrocardiogram (ECG) results</measure>
    <time_frame>77 days</time_frame>
    <description>measured by ECG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in continuous cardiac monitoring data</measure>
    <time_frame>15 days</time_frame>
    <description>measured with external monitoring device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in clinical laboratory test results</measure>
    <time_frame>77 days</time_frame>
    <description>measured by serum chemistry, hematology, serology and urinalysis results</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in body temperature</measure>
    <time_frame>77 days</time_frame>
    <description>measured in degrees Celsius or Fahrenheit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in respiratory rate</measure>
    <time_frame>77 days</time_frame>
    <description>measured by investigator</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in seated blood pressure</measure>
    <time_frame>77 days</time_frame>
    <description>measured by investigator</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in heart rate</measure>
    <time_frame>77 days</time_frame>
    <description>measured by investigator</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean heart rate (HR)</measure>
    <time_frame>15 days</time_frame>
    <description>Calculated from nadir HR to time-matched HR on Day -1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Largest decrease in HR from time-matched Day -1 baseline</measure>
    <time_frame>15 days</time_frame>
    <description>measured by investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to nadir HR from time 0 hour (predose)</measure>
    <time_frame>15 days</time_frame>
    <description>measured by investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to largest decrease HR from time 0 hour (predose)</measure>
    <time_frame>15 days</time_frame>
    <description>measured by investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in HR values by timepoint for BMS-986166-treated versus placebo-treated patients where the baseline is defined as time-matched Day -1 HR value</measure>
    <time_frame>15 days</time_frame>
    <description>measured by investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Largest percent decrease in absolute lymphocyte count (ALC) from time-matched Day -1 baseline</measure>
    <time_frame>35 days</time_frame>
    <description>measured by ALC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to largest percent reduction ALC from time 0 hour (predose)</measure>
    <time_frame>35 days</time_frame>
    <description>measured by ALC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean percent change from baseline in ALC values by timepoint for BMS-986166-treated versus placebo-treated patients where the baseline is defined as time-matched Day -1 ALC value</measure>
    <time_frame>77 days</time_frame>
    <description>measured by ALC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed blood concentration (Cmax)</measure>
    <time_frame>77 days</time_frame>
    <description>measured by blood concentration versus time data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of maximum observed blood concentration (Tmax)</measure>
    <time_frame>77 days</time_frame>
    <description>measured by blood concentration versus time data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (T-HALF)</measure>
    <time_frame>77 days</time_frame>
    <description>measured by blood concentration versus time data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))</measure>
    <time_frame>77 days</time_frame>
    <description>measured by blood concentration versus time data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))</measure>
    <time_frame>77 days</time_frame>
    <description>measured by blood concentration versus time data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent total clearance (CLT/F)</measure>
    <time_frame>77 days</time_frame>
    <description>measured by blood concentration versus time data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent steady state volume (Vz/F)</measure>
    <time_frame>77 days</time_frame>
    <description>measured by blood concentration versus time data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]</measure>
    <time_frame>77 days</time_frame>
    <description>Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]</measure>
    <time_frame>77 days</time_frame>
    <description>Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed concentration (Cmax)</measure>
    <time_frame>77 days</time_frame>
    <description>Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">213</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Dose Panel 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986166 or Placebo matching BMS-986166</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Panel 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986166 or Placebo matching BMS-986166</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Panel 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986166 or Placebo matching BMS-986166</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986166</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Dose Panel 1</arm_group_label>
    <arm_group_label>Dose Panel 2</arm_group_label>
    <arm_group_label>Dose Panel 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo matching BMS-986166</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Dose Panel 1</arm_group_label>
    <arm_group_label>Dose Panel 2</arm_group_label>
    <arm_group_label>Dose Panel 3</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 female patients of non-childbearing potential or male patients as determined&#xD;
             by medical history, physical examination, vital signs, 12-lead electrocardiogram&#xD;
             (ECG), and clinical laboratory evaluations will be eligible to participate in the&#xD;
             study&#xD;
&#xD;
          -  Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive&#xD;
&#xD;
          -  This study permits the re-enrollment of a patient that has discontinued the study as a&#xD;
             pre-treatment failure (i.e. patient has not been randomized / has not been treated).&#xD;
             If re-enrolled, the patient must be re-consented&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are of childbearing potential, lactating or breastfeeding&#xD;
&#xD;
          -  Any significant acute or chronic medical illness judged to be clinically significant&#xD;
             by the Investigator and/or Sponsor medical monitor&#xD;
&#xD;
          -  Patients with history of any type of heart disease, including ischemia, infarction,&#xD;
             clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic&#xD;
             orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope,&#xD;
             clinically significant ECG abnormalities, or any congenital heart disease&#xD;
&#xD;
          -  Patients with any acute or chronic bacterial, fungal (except history of tinea pedis or&#xD;
             ongoing onychomycosis will not be exclusionary) or viral infection within the last 3&#xD;
             months prior to screening, as well as any febrile illness or viral infection within&#xD;
             the last 3 months prior to screening, as well as any febrile illness of unknown origin&#xD;
             within 14 days of screening&#xD;
&#xD;
          -  Patients who have received any live vaccines within 1 month of study drug&#xD;
             administration, or who plan to have a live vaccine at any time during the study,&#xD;
             including during the follow up period&#xD;
&#xD;
          -  Positive test for tuberculosis at screening&#xD;
&#xD;
          -  Past or current history of neurologic disorders, Guillain-Barré Syndrome, central or&#xD;
             peripheral neuropathies, or past or current symptoms of sustained or recurrent&#xD;
             paresthesia's (tingling), numbness, or neuropathic pain (burning, aching or stabbing)&#xD;
             in any extremities&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could 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>PPD Development, LLC</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://bms.com/studyconnect/Pages/home.aspx</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</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>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</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/NCT03038711
org study id: IM018-003
nct id: NCT03038711
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to understand if multiple oral doses of BMS-986166 are safe and
      well tolerated in healthy patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Participant, Investigator)
measure: Incidence of All Adverse Events (AEs)
time frame: 77 days
description: measured by number of patients
measure: Incidence of Serious Adverse Events (SAEs)
time frame: 77 days
description: measured by number of patients
measure: Severity of all Adverse Events (AEs)
time frame: 77 days
description: measured by investigator
measure: Change from baseline in physical examination findings
time frame: 77 days
description: measured by investigator
measure: Change from baseline in electrocardiogram (ECG) results
time frame: 77 days
description: measured by ECG
measure: Change from baseline in continuous cardiac monitoring data
time frame: 15 days
description: measured with external monitoring device
measure: Change from baseline in clinical laboratory test results
time frame: 77 days
description: measured by serum chemistry, hematology, serology and urinalysis results
measure: Change from baseline in body temperature
time frame: 77 days
description: measured in degrees Celsius or Fahrenheit
measure: Change from baseline in respiratory rate
time frame: 77 days
description: measured by investigator
measure: Change from baseline in seated blood pressure
time frame: 77 days
description: measured by investigator
measure: Change from baseline in heart rate
time frame: 77 days
description: measured by investigator
measure: Mean heart rate (HR)
time frame: 15 days
description: Calculated from nadir HR to time-matched HR on Day -1
measure: Largest decrease in HR from time-matched Day -1 baseline
time frame: 15 days
description: measured by investigator
measure: Time to nadir HR from time 0 hour (predose)
time frame: 15 days
description: measured by investigator
measure: Time to largest decrease HR from time 0 hour (predose)
time frame: 15 days
description: measured by investigator
measure: Mean change from baseline in HR values by timepoint for BMS-986166-treated versus placebo-treated patients where the baseline is defined as time-matched Day -1 HR value
time frame: 15 days
description: measured by investigator
measure: Largest percent decrease in absolute lymphocyte count (ALC) from time-matched Day -1 baseline
time frame: 35 days
description: measured by ALC
measure: Time to largest percent reduction ALC from time 0 hour (predose)
time frame: 35 days
description: measured by ALC
measure: Mean percent change from baseline in ALC values by timepoint for BMS-986166-treated versus placebo-treated patients where the baseline is defined as time-matched Day -1 ALC value
time frame: 77 days
description: measured by ALC
measure: Maximum observed blood concentration (Cmax)
time frame: 77 days
description: measured by blood concentration versus time data
measure: Time of maximum observed blood concentration (Tmax)
time frame: 77 days
description: measured by blood concentration versus time data
measure: Terminal half-life (T-HALF)
time frame: 77 days
description: measured by blood concentration versus time data
measure: Area under the blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
time frame: 77 days
description: measured by blood concentration versus time data
measure: Area under the blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
time frame: 77 days
description: measured by blood concentration versus time data
measure: Apparent total clearance (CLT/F)
time frame: 77 days
description: measured by blood concentration versus time data
measure: Apparent steady state volume (Vz/F)
time frame: 77 days
description: measured by blood concentration versus time data
measure: Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
time frame: 77 days
description: Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
time frame: 77 days
description: Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter
measure: Maximum observed concentration (Cmax)
time frame: 77 days
description: Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter
arm group label: Dose Panel 1
arm group type: Experimental
description: BMS-986166 or Placebo matching BMS-986166
arm group label: Dose Panel 2
arm group type: Experimental
description: BMS-986166 or Placebo matching BMS-986166
arm group label: Dose Panel 3
arm group type: Experimental
description: BMS-986166 or Placebo matching BMS-986166
intervention type: Drug
intervention name: BMS-986166
description: Specified dose on specified days
arm group label: Dose Panel 1
arm group label: Dose Panel 2
arm group label: Dose Panel 3
intervention type: Other
intervention name: Placebo matching BMS-986166
description: Specified dose on specified days
arm group label: Dose Panel 1
arm group label: Dose Panel 2
arm group label: Dose Panel 3
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://bms.com/studyconnect/Pages/home.aspx
description: BMS Clinical Trial Patient Recruiting
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative