<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/NCT04423744</url>
  </required_header>
  <id_info>
    <org_study_id>21198</org_study_id>
    <secondary_id>2020-000516-29</secondary_id>
    <nct_id>NCT04423744</nct_id>
  </id_info>
  <brief_title>Study to Gather Information on the Influence of BAY1817080 on the Electrical Activity of the Heart Recorded by an Electrocardiogram in Healthy Male and Female Participants</brief_title>
  <official_title>Randomized, Single-blind, Double-dummy, 4-fold Cross-over, Placebo- and Active-controlled Study to Investigate the Influence of BAY 1817080 on the QTc Interval in Healthy Male and Female Participants (TQT Study)</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>
      In this study, researchers want to find whether the study drug BAY1817080 has an effect on&#xD;
      the electrocardiogram (ECG). 40 healthy male or female participants with the age of 18 to 65&#xD;
      years will be enrolled into this study. The ECG of the participants will be monitored closely&#xD;
      by the researchers to detect any change after intake of the study medication.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Actual">January 21, 2021</completion_date>
  <primary_completion_date type="Actual">November 9, 2020</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 therapeutic dose</measure>
    <time_frame>Baseline and Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 supra-therapeutic dose</measure>
    <time_frame>Baseline and Day 3</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after a single oral dose of moxifloxacin</measure>
    <time_frame>Baseline and Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-matched, placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) and Bazett (QTcB) after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose</measure>
    <time_frame>Baseline and Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-matched, placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) and Bazett (QTcB) after a single oral dose of moxifloxacin</measure>
    <time_frame>Baseline and Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC(0-24)md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose</measure>
    <time_frame>Predose and up to 24 hours after last dose of BAY1817080 at Day 3</time_frame>
    <description>Area under the concentration vs. time curve from zero to 24 hours after multiple doses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC after a single oral dose of moxifloxacin</measure>
    <time_frame>Predose and up to 24 hours after single dose of moxifloxacin at Day 3</time_frame>
    <description>Area under the concentration vs. time curve from zero to infinity after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose</measure>
    <time_frame>Up to 24 hours after last dose of BAY1817080 at Day 3</time_frame>
    <description>Maximum observed drug concentration in measured matrix after multiple doses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax after a single oral dose of moxifloxacin</measure>
    <time_frame>Up to 24 hours after single dose of moxifloxacin at Day 3</time_frame>
    <description>Maximum observed drug concentration in measured matrix after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidences of treatment-emergent adverse events (TEAEs) after BAY1817080 therapeutic or supra-therapeutic dose</measure>
    <time_frame>From the start of BAY1817080 administration until 7 days after last dose, assessed up to 10 days</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Cough</condition>
  <condition>Endometriosis</condition>
  <condition>Overactive Bladder</condition>
  <arm_group>
    <arm_group_label>Intervention ABCD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention A:&#xD;
Day 1 and 2: Supra-therapeutic dose of BAY1817080, three times daily (tid) Day 3: Supra-therapeutic dose of BAY1817080 and placebo to moxifloxacin, once&#xD;
Intervention B:&#xD;
Day 1 and 2: therapeutic dose of BAY1817080 and placebo to BAY1817080, tid Day 3: therapeutic dose of BAY1817080, placebo to BAY1817080 and placebo to moxifloxacin, once&#xD;
Intervention C:&#xD;
Day 1 and 2: Placebo to BAY1817080, tid Day 3: Placebo to BAY1817080 and moxifloxacin, once&#xD;
Intervention D:&#xD;
Day 1 and 2: Placebo to BAY1817080, tid Day 3: Placebo to BAY1817080 and placebo to moxifloxacin, once&#xD;
Subjects will receive intervention A, B, C and D sequentially. The washing-out period between each intervention is at least 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention BCDA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive intervention B, C, D and A sequentially. The washing-out period between each intervention is at least 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention CDAB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive intervention C, D, A and B sequentially. The washing-out period between each intervention is at least 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention DABC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive intervention D, A, B and C sequentially. The washing-out period between each intervention is at least 14 days&#xD;
Note: the intervention sequences in this and above arms are examples, the actual order of intervention may differ from these examples</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY1817080</intervention_name>
    <description>Film-coated tablet</description>
    <arm_group_label>Intervention ABCD</arm_group_label>
    <arm_group_label>Intervention BCDA</arm_group_label>
    <arm_group_label>Intervention CDAB</arm_group_label>
    <arm_group_label>Intervention DABC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxifloxacin</intervention_name>
    <description>Film-coated tablet</description>
    <arm_group_label>Intervention ABCD</arm_group_label>
    <arm_group_label>Intervention BCDA</arm_group_label>
    <arm_group_label>Intervention CDAB</arm_group_label>
    <arm_group_label>Intervention DABC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matched placebo as film-coated tablet</description>
    <arm_group_label>Intervention ABCD</arm_group_label>
    <arm_group_label>Intervention BCDA</arm_group_label>
    <arm_group_label>Intervention CDAB</arm_group_label>
    <arm_group_label>Intervention DABC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men must be 18 to 65 years of age inclusive, women must be 40 to 65 years of age&#xD;
             inclusive at the time of signing the informed consent&#xD;
&#xD;
          -  Female participants have to be in postmenopausal state&#xD;
&#xD;
          -  Body mass index (BMI) within the range 18.0-32.0 kg/m^2 (inclusive)&#xD;
&#xD;
          -  Participants who are overtly healthy as determined by medical evaluation including&#xD;
             medical history, physical examination, laboratory tests, ECG, and vital signs&#xD;
&#xD;
          -  12-lead electrocardiogram recording without signs of clinically relevant pathology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of relevant diseases of vital organs, of the central nervous system or other&#xD;
             organs&#xD;
&#xD;
          -  Pre-existing diseases for which it can be assumed that the absorption, distribution,&#xD;
             metabolism, elimination and effects of the study intervention will not be normal&#xD;
&#xD;
          -  Known hypersensitivity to the study interventions (active substances, or excipients of&#xD;
             the preparations)&#xD;
&#xD;
          -  Known severe allergies e.g. allergies to more than 3 allergens, allergies affecting&#xD;
             the lower respiratory tract - allergic asthma, allergies requiring therapy with&#xD;
             corticosteroids, urticaria or significant nonallergic drug reactions&#xD;
&#xD;
          -  Febrile illness within 1 week before study intervention administration&#xD;
&#xD;
          -  Known or suspected disorder of the liver (e.g. bile secretion/flow disorder, Morbus&#xD;
             Meulengracht (Gilbert´s syndrome), drug-induced hepatitis etc.)&#xD;
&#xD;
          -  History of disorder of the pancreas or evidence for past or present pancreas disorders&#xD;
             indicated by clinically relevant lipase or amylase levels above ULN and typical&#xD;
             clinical symptoms of pancreas disorders as e.g. upper abdominal pain spread to the&#xD;
             back, weight loss, fatty or pale stools&#xD;
&#xD;
          -  Participants with thyroid disorders as evidenced by assessment of thyroid stimulating&#xD;
             hormone (TSH) levels outside the normal reference range at screening (inclusion with&#xD;
             normal fT3/fT4 levels allowed)&#xD;
&#xD;
          -  History of known or suspected malignant tumors&#xD;
&#xD;
          -  History of hypokalemia&#xD;
&#xD;
          -  Use of CYP3A4 inhibitors from 14 days before study intervention administration until&#xD;
             the last study visit&#xD;
&#xD;
          -  Use of CYP3A4 inducers within 4 weeks (or at least five half-lives of the active&#xD;
             substance whatever is longer) prior to study intervention administration&#xD;
&#xD;
          -  Smoking more than 10 cigarettes daily&#xD;
&#xD;
          -  Suspicion of drug or alcohol abuse&#xD;
&#xD;
          -  Plasmapheresis within 3 months prior to study drug administration&#xD;
&#xD;
          -  Excluded physical therapies that might alter the PK or safety results of the study&#xD;
             (e.g. physiotherapy, acupuncture, etc.) from 7 days before first study drug&#xD;
             administration until follow-up&#xD;
&#xD;
          -  Systolic blood pressure below 100 mmHg or above 140 mmHg at screening. Difference of&#xD;
             systolic BP between both arms &gt;15 mmHg&#xD;
&#xD;
          -  Diastolic blood pressure below 50 mmHg or above 90 mmHg at screening&#xD;
&#xD;
          -  Heart rate below 50 beats/ min or above 90 beats/ min at screening&#xD;
&#xD;
          -  History of COVID-19&#xD;
&#xD;
          -  Prior contact with SARS-CoV-2 positive or COVID-19 patient within the last 4 weeks&#xD;
             prior admission to the ward&#xD;
&#xD;
          -  Positive SARS-CoV-2 viral test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CRS Clinical Research Services Mannheim GmbH</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Württemberg</state>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>January 19, 2022</last_update_submitted>
  <last_update_submitted_qc>January 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2022</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>Endometriosis</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moxifloxacin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Availability of this study's data will later 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. 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.</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/NCT04423744
org study id: 21198
secondary id: 2020-000516-29
nct id: NCT04423744
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, researchers want to find whether the study drug BAY1817080 has an effect on
      the electrocardiogram (ECG). 40 healthy male or female participants with the age of 18 to 65
      years will be enrolled into this study. The ECG of the participants will be monitored closely
      by the researchers to detect any change after intake of the study medication.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 therapeutic dose
time frame: Baseline and Day 3
measure: Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 supra-therapeutic dose
time frame: Baseline and Day 3
measure: Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after a single oral dose of moxifloxacin
time frame: Baseline and Day 3
measure: Time-matched, placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) and Bazett (QTcB) after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose
time frame: Baseline and Day 3
measure: Time-matched, placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) and Bazett (QTcB) after a single oral dose of moxifloxacin
time frame: Baseline and Day 3
measure: AUC(0-24)md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose
time frame: Predose and up to 24 hours after last dose of BAY1817080 at Day 3
description: Area under the concentration vs. time curve from zero to 24 hours after multiple doses
measure: AUC after a single oral dose of moxifloxacin
time frame: Predose and up to 24 hours after single dose of moxifloxacin at Day 3
description: Area under the concentration vs. time curve from zero to infinity after single dose
measure: Cmax,md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose
time frame: Up to 24 hours after last dose of BAY1817080 at Day 3
description: Maximum observed drug concentration in measured matrix after multiple doses
measure: Cmax after a single oral dose of moxifloxacin
time frame: Up to 24 hours after single dose of moxifloxacin at Day 3
description: Maximum observed drug concentration in measured matrix after single dose
measure: Incidences of treatment-emergent adverse events (TEAEs) after BAY1817080 therapeutic or supra-therapeutic dose
time frame: From the start of BAY1817080 administration until 7 days after last dose, assessed up to 10 days
arm group label: Intervention ABCD
arm group type: Experimental
description: Intervention A:
Day 1 and 2: Supra-therapeutic dose of BAY1817080, three times daily (tid) Day 3: Supra-therapeutic dose of BAY1817080 and placebo to moxifloxacin, once
Intervention B:
Day 1 and 2: therapeutic dose of BAY1817080 and placebo to BAY1817080, tid Day 3: therapeutic dose of BAY1817080, placebo to BAY1817080 and placebo to moxifloxacin, once
Intervention C:
Day 1 and 2: Placebo to BAY1817080, tid Day 3: Placebo to BAY1817080 and moxifloxacin, once
Intervention D:
Day 1 and 2: Placebo to BAY1817080, tid Day 3: Placebo to BAY1817080 and placebo to moxifloxacin, once
Subjects will receive intervention A, B, C and D sequentially. The washing-out period between each intervention is at least 14 days
arm group label: Intervention BCDA
arm group type: Experimental
description: Subjects will receive intervention B, C, D and A sequentially. The washing-out period between each intervention is at least 14 days
arm group label: Intervention CDAB
arm group type: Experimental
description: Subjects will receive intervention C, D, A and B sequentially. The washing-out period between each intervention is at least 14 days
arm group label: Intervention DABC
arm group type: Experimental
description: Subjects will receive intervention D, A, B and C sequentially. The washing-out period between each intervention is at least 14 days
Note: the intervention sequences in this and above arms are examples, the actual order of intervention may differ from these examples
intervention type: Drug
intervention name: BAY1817080
description: Film-coated tablet
arm group label: Intervention ABCD
arm group label: Intervention BCDA
arm group label: Intervention CDAB
arm group label: Intervention DABC
intervention type: Drug
intervention name: Moxifloxacin
description: Film-coated tablet
arm group label: Intervention ABCD
arm group label: Intervention BCDA
arm group label: Intervention CDAB
arm group label: Intervention DABC
intervention type: Drug
intervention name: Placebo
description: Matched placebo as film-coated tablet
arm group label: Intervention ABCD
arm group label: Intervention BCDA
arm group label: Intervention CDAB
arm group label: Intervention DABC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
url: https://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products
responsible party type: Sponsor
mesh term: Endometriosis
mesh term: Urinary Bladder, Overactive
mesh term: Moxifloxacin
sharing ipd: No
ipd description: Availability of this study's data will later 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.