<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/NCT03262740</url>
  </required_header>
  <id_info>
    <org_study_id>IM014-023</org_study_id>
    <nct_id>NCT03262740</nct_id>
  </id_info>
  <brief_title>The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients</brief_title>
  <official_title>The Effect of BMS-986195 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female 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 investigate the effect of BMS-986195 in combination with an&#xD;
      oral contraceptive in healthy female patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">January 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 19, 2017</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>Maximum concentration (Cmax) derived from plasma concentration versus time</measure>
    <time_frame>Approximately 1 day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve to the end of the dosing period [AUC(tau)] derived from plasma concentration versus time</measure>
    <time_frame>Approximately 1 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events measured by incidence</measure>
    <time_frame>Approximately 86 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events measured by incidence</measure>
    <time_frame>Approximately 86 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>BMS-986195 and Oral Contraceptive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral administration of contraceptive, then progress to combination</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986195</intervention_name>
    <description>Oral administration of specified dose on specified days</description>
    <arm_group_label>BMS-986195 and Oral Contraceptive</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)</intervention_name>
    <description>Oral Contraceptive</description>
    <arm_group_label>BMS-986195 and Oral Contraceptive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive,&#xD;
&#xD;
          -  Weight ≥ 50 kg&#xD;
&#xD;
          -  Negative result for tuberculosis (TB) as evidenced by a QuantiFERON-TB Gold Plus test&#xD;
             at screening, or documentation of a negative result within 4 weeks before Cycle 1, Day&#xD;
             1&#xD;
&#xD;
          -  Women of childbearing potential with intact ovarian function, on a stable regimen of&#xD;
             combination birth control containing EE without evidence of clinically significant&#xD;
             breakthrough bleeding or spotting for at least 2 consecutive months prior to Cycle 1&#xD;
             Day -1&#xD;
&#xD;
          -  Subjects aged 21 years or older must have a normal Pap smear result within 3 years&#xD;
             before Cycle 1 Day 1 (a Pap smear may be performed at screening if no result is&#xD;
             available); a finding of abnormal squamous cells of unknown significance (ASCUS) is&#xD;
             allowed provided it is an initial finding and not a follow up from an initial finding&#xD;
             of ASCUS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exposure to an investigational agent within 12 weeks before Cycle 1 Day 1&#xD;
&#xD;
          -  Subjects who are pregnant or breastfeeding&#xD;
&#xD;
          -  Any significant acute or chronic medical illness including infection, any active&#xD;
             infection, febrile illness within 7 days before Cycle 1, Day 1, or any condition that&#xD;
             could predispose the subject to infection&#xD;
&#xD;
          -  History of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract&#xD;
             infection (recurrent or chronic urinary tract infection is 2 episodes within 6 months)&#xD;
&#xD;
          -  Any serious acute or chronic bacterial, fungal, or viral infection (eg, pneumonia,&#xD;
             septicemia) within the 3 months prior to screening&#xD;
&#xD;
          -  Known or suspected autoimmune disorder, or any history of known or suspected&#xD;
             congenital or acquired immunodeficiency state or condition that would compromise the&#xD;
             subject's immune status (eg, history of splenectomy, primary immunodeficiency, etc)&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could apply&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 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>Miami Research Associates</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PRA Health Sciences</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>http://bms.com/studyconnect/Pages/home.aspx</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>March 19, 2020</last_update_submitted>
  <last_update_submitted_qc>March 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 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</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethinyl Estradiol</mesh_term>
    <mesh_term>Norethindrone</mesh_term>
    <mesh_term>Norethindrone Acetate</mesh_term>
    <mesh_term>Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination</mesh_term>
    <mesh_term>Estradiol</mesh_term>
    <mesh_term>Branebrutinib</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/NCT03262740
org study id: IM014-023
nct id: NCT03262740
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to investigate the effect of BMS-986195 in combination with an
      oral contraceptive in healthy female patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum concentration (Cmax) derived from plasma concentration versus time
time frame: Approximately 1 day
measure: Area under the plasma concentration-time curve to the end of the dosing period [AUC(tau)] derived from plasma concentration versus time
time frame: Approximately 1 day
measure: Adverse events measured by incidence
time frame: Approximately 86 days
measure: Serious adverse events measured by incidence
time frame: Approximately 86 days
arm group label: BMS-986195 and Oral Contraceptive
arm group type: Experimental
description: Oral administration of contraceptive, then progress to combination
intervention type: Drug
intervention name: BMS-986195
description: Oral administration of specified dose on specified days
arm group label: BMS-986195 and Oral Contraceptive
intervention type: Drug
intervention name: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)
description: Oral Contraceptive
arm group label: BMS-986195 and Oral Contraceptive
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
facility: 
country: United States
url: http://bms.com/studyconnect/Pages/home.aspx
description: BMS Clinical Trial Patient Recruiting
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Ethinyl Estradiol
mesh term: Norethindrone
mesh term: Norethindrone Acetate
mesh term: Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
mesh term: Estradiol
mesh term: Branebrutinib