<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/NCT03789890</url>
  </required_header>
  <id_info>
    <org_study_id>19431</org_study_id>
    <secondary_id>2018-003212-50</secondary_id>
    <nct_id>NCT03789890</nct_id>
  </id_info>
  <brief_title>Study to Learn More About the Effect of Itraconazole (ITZ) Given Repeatedly by Mouth on the Way How the Study Drug BAY1902607 Given One Time by Mouth Acts in the Human Body of Healthy Male Participants</brief_title>
  <official_title>An Open-label, Single Group Study to Evaluate the Effect of Repeated Oral Administration of Itraconazole (ITZ) on the Single Oral Dose Pharmacokinetics of BAY1902607 in Healthy Male Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      BAY1902607 is a new type of drug under clinical development for different conditions&#xD;
      including the treatment of endometriosis, i.e. a condition where the tissue that usually&#xD;
      grows inside the womb grows outside of the womb.&#xD;
&#xD;
      Itraconazole (ITZ) is an approved drug often used for the treatment of fungal infections and&#xD;
      possibly inhibits the breakdown of BAY1902607. In this clinical study, BAY1902607 is given&#xD;
      alone by mouth or in combination with ITZ. Researchers want to learn more how quickly and to&#xD;
      what extent the study drug BAY1902607 given by mouth to healthy male participants is absorbed&#xD;
      by the human body, reaches the blood stream and is excreted again. In addition they want to&#xD;
      find out whether the elimination of the study drug BAY1902607 is influenced by ITZ given at&#xD;
      the same time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">May 23, 2019</completion_date>
  <primary_completion_date type="Actual">March 4, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax of BAY1902607</measure>
    <time_frame>-0.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 96 hours after drug</time_frame>
    <description>Maximum concentration of BAY1902607 in blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of BAY1902607 with itraconazole</measure>
    <time_frame>-1.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours after BAY1902607</time_frame>
    <description>Maximum concentration of BAY1902607 in blood with concomitant administration of itraconazole</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC of BAY1902607</measure>
    <time_frame>-0.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 96 hours after drug</time_frame>
    <description>Area under the concentration versus time curve of BAY1902607 (time from 0 to 96 hours) after single dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC of BAY1902607 with itraconazole</measure>
    <time_frame>-1.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours after BAY1902607</time_frame>
    <description>Area under the concentration versus time curve (time from 0 to 264 hours) after single dose of BAY1902607 and concomitant administration of itraconazole</description>
  </primary_outcome>
  <other_outcome>
    <measure>Number of participants with treatment-emergent adverse events</measure>
    <time_frame>Up to 5 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Intensity of treatment-emergent adverse events</measure>
    <time_frame>Up to 5 weeks</time_frame>
    <description>Adverse events will be assigned to one of three categories: mild (easily tolerated and no interference with everyday activities), moderate (sufficient discomfort and interferes with everyday activities) &amp; severe (prevents normal everyday activities).</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Drug Interactions</condition>
  <arm_group>
    <arm_group_label>Healthy men</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy male adults from Germany receiving BAY1902607 during study period 1 (length = 6 days) and BAY1902607 + Itraconazole during study period 2 (length = 15 days), separated by a washout phase.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY1902607</intervention_name>
    <description>BAY1902607 is administered once orally as tablets on Day 2 of study period 1 and on Day 4 of study period 2.</description>
    <arm_group_label>Healthy men</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itraconazole</intervention_name>
    <description>Itraconazole is administered at a dose of 200 mg once a day (oral solution of 10 mg mL-1) on Day 1 to Day 14 of study period 2.</description>
    <arm_group_label>Healthy men</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, male adults&#xD;
&#xD;
          -  Body mass index ≥ 18 and ≤ 30.0 kg/m²&#xD;
&#xD;
          -  Body weight ≥ 50 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected allergy or hypersensitivity to BAY1902607, itraconazole or any of&#xD;
             their excipients&#xD;
&#xD;
          -  Contraindications to itraconazole (symptoms or history of ventricular dysfunction,&#xD;
             heart failure, liver disease).&#xD;
&#xD;
          -  Any use of systemic or topically active medication or herbal remedies, prescription or&#xD;
             non-prescription, within 1 week prior to the first drug administration or during the&#xD;
             trial until follow-up (occasional use of ibuprofen is permissible). Particularly, this&#xD;
             includes drugs that might affect the pharmacokinetics (PK) of BAY1902607, e.g.&#xD;
             laxatives, loperamide, metoclopramide, antacids, H2-receptor antagonists, CYP3A4&#xD;
             inhibitors or inducers.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CRS Clinical Research Services Berlin GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>May 27, 2019</last_update_submitted>
  <last_update_submitted_qc>May 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug-drug interaction</keyword>
  <keyword>Itraconazole (ITZ)</keyword>
  <keyword>Cytochrom P450 3A4 (CYP3A4) metabolism</keyword>
  <keyword>P2X3-inhibitor</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Itraconazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access.&#xD;
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.&#xD;
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.</ipd_description>
  </patient_data>
  <!-- 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/NCT03789890
org study id: 19431
secondary id: 2018-003212-50
nct id: NCT03789890
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
BAY1902607 is a new type of drug under clinical development for different conditions
      including the treatment of endometriosis, i.e. a condition where the tissue that usually
      grows inside the womb grows outside of the womb.

      Itraconazole (ITZ) is an approved drug often used for the treatment of fungal infections and
      possibly inhibits the breakdown of BAY1902607. In this clinical study, BAY1902607 is given
      alone by mouth or in combination with ITZ. Researchers want to learn more how quickly and to
      what extent the study drug BAY1902607 given by mouth to healthy male participants is absorbed
      by the human body, reaches the blood stream and is excreted again. In addition they want to
      find out whether the elimination of the study drug BAY1902607 is influenced by ITZ given at
      the same time.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cmax of BAY1902607
time frame: -0.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 96 hours after drug
description: Maximum concentration of BAY1902607 in blood
measure: Cmax of BAY1902607 with itraconazole
time frame: -1.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours after BAY1902607
description: Maximum concentration of BAY1902607 in blood with concomitant administration of itraconazole
measure: AUC of BAY1902607
time frame: -0.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 96 hours after drug
description: Area under the concentration versus time curve of BAY1902607 (time from 0 to 96 hours) after single dose
measure: AUC of BAY1902607 with itraconazole
time frame: -1.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours after BAY1902607
description: Area under the concentration versus time curve (time from 0 to 264 hours) after single dose of BAY1902607 and concomitant administration of itraconazole
measure: Number of participants with treatment-emergent adverse events
time frame: Up to 5 weeks
measure: Intensity of treatment-emergent adverse events
time frame: Up to 5 weeks
description: Adverse events will be assigned to one of three categories: mild (easily tolerated and no interference with everyday activities), moderate (sufficient discomfort and interferes with everyday activities) & severe (prevents normal everyday activities).
arm group label: Healthy men
arm group type: Experimental
description: Healthy male adults from Germany receiving BAY1902607 during study period 1 (length = 6 days) and BAY1902607 + Itraconazole during study period 2 (length = 15 days), separated by a washout phase.
intervention type: Drug
intervention name: BAY1902607
description: BAY1902607 is administered once orally as tablets on Day 2 of study period 1 and on Day 4 of study period 2.
arm group label: Healthy men
intervention type: Drug
intervention name: Itraconazole
description: Itraconazole is administered at a dose of 200 mg once a day (oral solution of 10 mg mL-1) on Day 1 to Day 14 of study period 2.
arm group label: Healthy men
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Itraconazole
sharing ipd: Undecided
ipd description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.