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/NCT05965583</url>
    </required_header>
    <id_info>
      <org_study_id>1485-0003</org_study_id>
      <nct_id>NCT05965583</nct_id>
    </id_info>
    <brief_title>A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1815368 in the Blood</brief_title>
    <official_title>Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1815368 in Healthy Male Subjects (an Open-label, Two-period Fixed-sequence Design Study)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boehringer Ingelheim</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Boehringer Ingelheim</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 main objective of this trial is to investigate the effect on the exposure of BI 1815368&#xD;
        in plasma when given as oral single dose together with multiple oral doses of itraconazole&#xD;
        (Test, T) as compared to when given alone as oral single dose (Reference, R).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">October 24, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 24, 2023</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Patients cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)</measure>
      <time_frame>Up to day 7 after BI 1815368 administration</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum measured concentration of the analyte in plasma (Cmax)</measure>
      <time_frame>Up to day 7 after BI 1815368 administration</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)</measure>
      <time_frame>Up to day 7 after BI 1815368 administration</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">14</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BI 1815368</intervention_name>
      <description>BI 1815368</description>
      <arm_group_label>BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Itraconazole</intervention_name>
      <description>Itraconazole</description>
      <arm_group_label>BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)</arm_group_label>
      <other_name>Sempera®</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy male subjects according to the assessment of the investigator, as based on a&#xD;
               complete medical history including a physical examination, vital signs (blood&#xD;
               pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests&#xD;
  &#xD;
            -  Age of 18 to 55 years (inclusive)&#xD;
  &#xD;
            -  Body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2) (inclusive)&#xD;
  &#xD;
            -  Signed and dated written informed consent in accordance with International Conference&#xD;
               of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to&#xD;
               admission to the trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any finding in the medical examination (including blood pressure, pulse rate or&#xD;
               electrocardiogram) deviating from normal and assessed as clinically relevant by the&#xD;
               investigator&#xD;
  &#xD;
            -  Repeated measurement of systolic blood pressure outside the range of 90 to 140&#xD;
               millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90&#xD;
               mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)&#xD;
  &#xD;
            -  Any laboratory value outside the reference range that the investigator considers to be&#xD;
               of clinical relevance&#xD;
  &#xD;
            -  Any evidence of a concomitant disease assessed as clinically relevant by the&#xD;
               investigator&#xD;
  &#xD;
            -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
               immunological or hormonal disorders&#xD;
  &#xD;
            -  Cholecystectomy or other surgery of the gastrointestinal tract that could interfere&#xD;
               with the pharmacokinetics of the trial medication (except appendectomy or simple&#xD;
               hernia repair)&#xD;
  &#xD;
            -  Diseases of the central nervous system (including but not limited to any kind of&#xD;
               seizures or stroke), and other relevant neurological or psychiatric disorders&#xD;
  &#xD;
            -  History of relevant orthostatic hypotension, fainting spells, or blackouts&#xD;
  &#xD;
            -  Relevant chronic or acute infections&#xD;
  &#xD;
          Further exclusion criteria may apply.&#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>
    <overall_contact>
      <last_name>Boehringer Ingelheim</last_name>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Humanpharmakologisches Zentrum Biberach</name>
        <address>
          <city>Biberach</city>
          <zip>88397</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Boehringer Ingelheim</last_name>
        <phone>08007234742</phone>
        <email>deutschland@bitrialsupport.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <link>
      <url>https://www.mystudywindow.com</url>
      <description>Related Info</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Itraconazole</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).&#xD;
  For more details refer to:&#xD;
  https://www.mystudywindow.com/msw/datatransparency</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/NCT05965583
  org study id: 1485-0003
  nct id: NCT05965583
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The main objective of this trial is to investigate the effect on the exposure of BI 1815368
        in plasma when given as oral single dose together with multiple oral doses of itraconazole
        (Test, T) as compared to when given alone as oral single dose (Reference, R).
  allocation: N/A
  intervention model: Crossover Assignment
  intervention model description: Patients cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
  time frame: Up to day 7 after BI 1815368 administration
  measure: Maximum measured concentration of the analyte in plasma (Cmax)
  time frame: Up to day 7 after BI 1815368 administration
  measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
  time frame: Up to day 7 after BI 1815368 administration
  arm group label: BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)
  arm group type: Experimental
  intervention type: Drug
  intervention name: BI 1815368
  description: BI 1815368
  arm group label: BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)
  intervention type: Drug
  intervention name: Itraconazole
  description: Itraconazole
  arm group label: BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)
  other name: Sempera®
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Boehringer Ingelheim
  phone: 1-800-243-0127
  email: clintriage.rdg@boehringer-ingelheim.com
  facility: 
  status: Recruiting
  contact: 
  country: Germany
  url: https://www.mystudywindow.com
  description: Related Info
  responsible party type: Sponsor
  mesh term: Itraconazole
  sharing ipd: No
  ipd description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
  For more details refer to:
  https://www.mystudywindow.com/msw/datatransparency