xml: <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/NCT05985590</url>
    </required_header>
    <id_info>
      <org_study_id>IM027-1013</org_study_id>
      <nct_id>NCT05985590</nct_id>
    </id_info>
    <brief_title>A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants</brief_title>
    <official_title>A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of Multiple Doses of BMS-986278 on the Pharmacokinetics of Combined Oral Contraceptives (Drospirenone/Ethinyl Estradiol) in Healthy Female 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 the study is to assess the effects of BMS-986278 on Drospirenone (DRSP) and&#xD;
        Ethinyl Estradiol (EE) when administered as a combined oral contraceptive in healthy female&#xD;
        participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">November 7, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 7, 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</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 observed plasma concentration (Cmax)</measure>
      <time_frame>Predose and post-dose up to Day 28</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])</measure>
      <time_frame>Predose and post-dose up to Day 28</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])</measure>
      <time_frame>Predose and post-dose up to Day 28</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time of maximum observed concentration (Tmax)</measure>
      <time_frame>Predose and post-dose up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal half-life (T-Half)</measure>
      <time_frame>Predose and post-dose up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent total body clearance after extravascular administration (CL/F)</measure>
      <time_frame>Predose and post-dose up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Adverse Events (AEs)</measure>
      <time_frame>Up to Day 53</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Serious AEs (SAEs)</measure>
      <time_frame>Up to Day 53</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with AEs leading to discontinuation</measure>
      <time_frame>Up to Day 53</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Physical Examination Abnormalities</measure>
      <time_frame>Up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Vital Sign Abnormalities</measure>
      <time_frame>Up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Electrocardiogram (ECG) Abnormalities</measure>
      <time_frame>Up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Clinical Laboratory Abnormalities</measure>
      <time_frame>Up to Day 27</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Treatment A: DRSP/EE</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment B: BMS-986278/DRSP/EE</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BMS-986278</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>Treatment B: BMS-986278/DRSP/EE</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Drospirenone/Ethinyl Estradiol</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>Treatment A: DRSP/EE</arm_group_label>
      <arm_group_label>Treatment B: BMS-986278/DRSP/EE</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Body mass index between 18.0 and 32.0 kilograms/meter square (kg/m^2), inclusive.&#xD;
  &#xD;
            -  Body weight ≥ 45 kg.&#xD;
  &#xD;
            -  Healthy females, as determined by physical examination and clinical laboratory&#xD;
               assessments (including chemistry, hematology, coagulation, and urinalysis) within the&#xD;
               normal range at the screening visit and on Day -1, as applicable.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any significant acute or chronic medical illness.&#xD;
  &#xD;
            -  Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other&#xD;
               procedures (eg, bariatric procedures) that could affect drug absorption, distribution,&#xD;
               metabolism, and excretion. Note: Appendectomy is allowed (12 months prior to&#xD;
               screening).&#xD;
  &#xD;
            -  Any other clinically significant medical, psychiatric, and/or social reason, or other&#xD;
               active issues, especially eye issues, as determined by the investigator.&#xD;
  &#xD;
          Note: Other protocol-defined inclusion/exclusion criteria apply.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 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>
    <overall_contact>
      <last_name>BMS Study Connect Contact Center www.BMSStudyConnect.com</last_name>
      <phone>855-907-3286</phone>
      <email>Clinical.Trials@bms.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>First line of the email MUST contain the NCT# and Site #.</last_name>
    </overall_contact_backup>
    <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.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
      <description>FDA Safety Alerts and Recalls</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>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pharmacokinetics</keyword>
    <keyword>BMS-986278</keyword>
    <keyword>Hormonal contraceptives</keyword>
    <keyword>Ethinyl estradiol</keyword>
    <keyword>Drospirenone</keyword>
    <keyword>Pulmonary fibrosis</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Drospirenone</mesh_term>
      <mesh_term>Ethinyl Estradiol</mesh_term>
      <mesh_term>Drospirenone and ethinyl estradiol combination</mesh_term>
      <mesh_term>Estradiol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985590
  org study id: IM027-1013
  nct id: NCT05985590
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of the study is to assess the effects of BMS-986278 on Drospirenone (DRSP) and
        Ethinyl Estradiol (EE) when administered as a combined oral contraceptive in healthy female
        participants.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Maximum observed plasma concentration (Cmax)
  time frame: Predose and post-dose up to Day 28
  measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
  time frame: Predose and post-dose up to Day 28
  measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
  time frame: Predose and post-dose up to Day 28
  measure: Time of maximum observed concentration (Tmax)
  time frame: Predose and post-dose up to Day 28
  measure: Terminal half-life (T-Half)
  time frame: Predose and post-dose up to Day 28
  measure: Apparent total body clearance after extravascular administration (CL/F)
  time frame: Predose and post-dose up to Day 28
  measure: Number of Participants with Adverse Events (AEs)
  time frame: Up to Day 53
  measure: Number of Participants with Serious AEs (SAEs)
  time frame: Up to Day 53
  measure: Number of Participants with AEs leading to discontinuation
  time frame: Up to Day 53
  measure: Number of Participants with Physical Examination Abnormalities
  time frame: Up to Day 28
  measure: Number of Participants with Vital Sign Abnormalities
  time frame: Up to Day 28
  measure: Number of Participants with Electrocardiogram (ECG) Abnormalities
  time frame: Up to Day 28
  measure: Number of Participants with Clinical Laboratory Abnormalities
  time frame: Up to Day 27
  arm group label: Treatment A: DRSP/EE
  arm group type: Experimental
  arm group label: Treatment B: BMS-986278/DRSP/EE
  arm group type: Experimental
  intervention type: Drug
  intervention name: BMS-986278
  description: Specified dose on specified days
  arm group label: Treatment B: BMS-986278/DRSP/EE
  intervention type: Drug
  intervention name: Drospirenone/Ethinyl Estradiol
  description: Specified dose on specified days
  arm group label: Treatment A: DRSP/EE
  arm group label: Treatment B: BMS-986278/DRSP/EE
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bristol-Myers Squibb
  role: Study Director
  affiliation: Bristol-Myers Squibb
  last name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  phone: 855-907-3286
  email: Clinical.Trials@bms.com
  last name: First line of the email MUST contain the NCT# and Site #.
  url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
  description: BMS Clinical Trial Information
  url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
  description: FDA Safety Alerts and Recalls
  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
  responsible party type: Sponsor
  mesh term: Drospirenone
  mesh term: Ethinyl Estradiol
  mesh term: Drospirenone and ethinyl estradiol combination
  mesh term: Estradiol
  sharing ipd: No
  ipd description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html