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/NCT06006598</url>
    </required_header>
    <id_info>
      <org_study_id>1484-0002</org_study_id>
      <nct_id>NCT06006598</nct_id>
    </id_info>
    <brief_title>A Study to Test How Well Different Doses of BI 1584862 Are Tolerated by Healthy Men</brief_title>
    <official_title>Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1584862 in Healthy Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)</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>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main objectives of this trial are to investigate safety, tolerability, and&#xD;
        pharmacokinetics of BI 1584862 in healthy male subjects following administration of multiple&#xD;
        rising doses.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">May 6, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 6, 2024</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator</measure>
      <time_frame>Up to 27 days</time_frame>
      <description>expressed as the percentage of subjects treated with investigational drug who experience such an event</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)</measure>
      <time_frame>Up to 15 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)</measure>
      <time_frame>Up to 15 days</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>BI 1584862 treatment arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo arm</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BI 1584862 + midazolam treatment arm</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 treatment arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo matching BI 1584862</intervention_name>
      <description>Placebo matching BI 1584862</description>
      <arm_group_label>Placebo arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>midazolam</intervention_name>
      <description>midazolam</description>
      <arm_group_label>BI 1584862 + midazolam treatment arm</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 indey (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 50 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>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 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>Midazolam</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/NCT06006598
  org study id: 1484-0002
  nct id: NCT06006598
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main objectives of this trial are to investigate safety, tolerability, and
        pharmacokinetics of BI 1584862 in healthy male subjects following administration of multiple
        rising doses.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
  time frame: Up to 27 days
  description: expressed as the percentage of subjects treated with investigational drug who experience such an event
  measure: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
  time frame: Up to 15 days
  measure: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
  time frame: Up to 15 days
  arm group label: BI 1584862 treatment arm
  arm group type: Experimental
  arm group label: Placebo arm
  arm group type: Placebo Comparator
  arm group label: BI 1584862 + midazolam treatment arm
  arm group type: Experimental
  intervention type: Drug
  intervention name: BI 1584862
  description: BI 1584862
  arm group label: BI 1584862 treatment arm
  intervention type: Drug
  intervention name: Placebo matching BI 1584862
  description: Placebo matching BI 1584862
  arm group label: Placebo arm
  intervention type: Drug
  intervention name: midazolam
  description: midazolam
  arm group label: BI 1584862 + midazolam treatment arm
  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: Midazolam
  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