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/NCT06041438</url>
    </required_header>
    <id_info>
      <org_study_id>1484-0003</org_study_id>
      <secondary_id>2023-503542-31-00</secondary_id>
      <nct_id>NCT06041438</nct_id>
    </id_info>
    <brief_title>A Study in Healthy Men to Test Whether Itraconazole Influences the Amount of BI 1584862 in the Blood</brief_title>
    <official_title>Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1584862 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 1584862&#xD;
        in plasma when given as single dose together with multiple doses of itraconazole (Test, T) as&#xD;
        compared to BI 1584862 when given alone as oral single dose (Reference, R).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 29, 2023</start_date>
    <completion_date type="Anticipated">November 10, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 10, 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>Sequential Assignment</intervention_model>
      <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 3 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum measured concentration of the analyte in plasma (Cmax)</measure>
      <time_frame>Up to 3 days</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 3 days</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 1584862 alone (Reference R) - BI 1584862 + itraconazole (Test T)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BI 1584862</intervention_name>
      <description>BI 1584862</description>
      <arm_group_label>BI 1584862 alone (Reference R) - BI 1584862 + 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 1584862 alone (Reference R) - BI 1584862 + itraconazole (Test T)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 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 pressure&#xD;
               (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests&#xD;
  &#xD;
            2. Age of 18 to 50 years (inclusive)&#xD;
  &#xD;
            3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)&#xD;
  &#xD;
            4. Signed and dated written informed consent in accordance with ICH-GCP and local&#xD;
               legislation prior to admission to the trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal&#xD;
               and assessed as clinically relevant by the investigator&#xD;
  &#xD;
            2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,&#xD;
               diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the&#xD;
               range of 45 to 90 bpm&#xD;
  &#xD;
            3. Any laboratory value outside the reference range that the investigator considers to be&#xD;
               of clinical relevance&#xD;
  &#xD;
            4. Any evidence of a concomitant disease assessed as clinically relevant by the&#xD;
               investigator&#xD;
  &#xD;
            5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
               immunological or hormonal disorders&#xD;
  &#xD;
            6. 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;
            7. 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;
            8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further&#xD;
               exclusion criteria apply&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 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>
    <link>
      <url>http://www.mystudywindow.com</url>
      <description>Related Info</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>September 12, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 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/NCT06041438
  org study id: 1484-0003
  secondary id: 2023-503542-31-00
  nct id: NCT06041438
  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 1584862
        in plasma when given as single dose together with multiple doses of itraconazole (Test, T) as
        compared to BI 1584862 when given alone as oral single dose (Reference, R).
  allocation: N/A
  intervention model: Sequential Assignment
  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 3 days
  measure: Maximum measured concentration of the analyte in plasma (Cmax)
  time frame: Up to 3 days
  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 3 days
  arm group label: BI 1584862 alone (Reference R) - BI 1584862 + itraconazole (Test T)
  arm group type: Experimental
  intervention type: Drug
  intervention name: BI 1584862
  description: BI 1584862
  arm group label: BI 1584862 alone (Reference R) - BI 1584862 + itraconazole (Test T)
  intervention type: Drug
  intervention name: itraconazole
  description: itraconazole
  arm group label: BI 1584862 alone (Reference R) - BI 1584862 + itraconazole (Test T)
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Boehringer Ingelheim
  phone: 1-800-243-0127
  email: clintriage.rdg@boehringer-ingelheim.com
  url: http://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