<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/NCT04439838</url>
  </required_header>
  <id_info>
    <org_study_id>1445-0001</org_study_id>
    <secondary_id>2020-001036-10</secondary_id>
    <nct_id>NCT04439838</nct_id>
  </id_info>
  <brief_title>A Study in Healthy Men to Test How Different Doses of BI 1595043 Are Tolerated</brief_title>
  <official_title>Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1595043 (Single-blind, Partially Randomised, Placebo-controlled, Parallel (Sequential) Group Design) in Healthy Male Subjects</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 (PK) of BI 1595043 in healthy male subjects following oral administration of&#xD;
      single rising doses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Actual">March 19, 2021</completion_date>
  <primary_completion_date type="Actual">March 19, 2021</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>Percentage of subjects with drug-related adverse events</measure>
    <time_frame>Up to 15 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)</measure>
    <time_frame>Up to 9 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum measured concentration of BI 1595043 in plasma (Cmax)</measure>
    <time_frame>Up to 9 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1595043</intervention_name>
    <description>BI 1595043</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo group</arm_group_label>
  </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 (BP, PR),&#xD;
             12-lead ECG, and clinical laboratory tests&#xD;
&#xD;
          -  Age of 18 to 50 years (inclusive)&#xD;
&#xD;
          -  BMI of 18.5 to 29.9 kg/m2 (inclusive)&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study, in&#xD;
             accordance with GCP and local legislation&#xD;
&#xD;
          -  Male subjects who meet any of the following criteria from at least 30 days before the&#xD;
             first administration of trial medication until 30 days after trial completion:&#xD;
&#xD;
               -  Use of adequate contraception, e.g. use of condom (male subjects) plus any of the&#xD;
                  following methods (female partners): intrauterine device, hormonal contraception&#xD;
                  (e.g. implants, injectables, combined oral or vaginal contraceptives) that&#xD;
                  started at least 2 months prior to first drug administration to the male subject,&#xD;
                  or barrier method (e.g. diaphragm with spermicide), or surgically sterilised&#xD;
                  (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or&#xD;
                  postmenopausal, defined as at least 1 year of spontaneous amenorrhea&#xD;
&#xD;
               -  Sexually abstinent&#xD;
&#xD;
               -  Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a&#xD;
                  barrier method (e.g. condom)&#xD;
&#xD;
          -  Unprotected sexual intercourse with a pregnant female partner and sperm donation is&#xD;
             not allowed throughout the study and until 30 days after trial completion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  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;
          -  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;
          -  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;
          -  Further 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>
  <location>
    <facility>
      <name>SGS Life Science Services - Clinical Research</name>
      <address>
        <city>Antwerpen</city>
        <zip>2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>March 23, 2021</last_update_submitted>
  <last_update_submitted_qc>March 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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, except for the following exclusions:&#xD;
studies in products where Boehringer Ingelheim is not the license holder;&#xD;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;&#xD;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).&#xD;
For more details refer to: http://trials.boehringer-ingelheim.com/</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>July 5, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04439838
org study id: 1445-0001
secondary id: 2020-001036-10
nct id: NCT04439838
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 (PK) of BI 1595043 in healthy male subjects following oral administration of
      single rising doses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Percentage of subjects with drug-related adverse events
time frame: Up to 15 days
measure: Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
time frame: Up to 9 days
measure: Maximum measured concentration of BI 1595043 in plasma (Cmax)
time frame: Up to 9 days
arm group label: Treatment group
arm group type: Experimental
arm group label: Placebo group
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BI 1595043
description: BI 1595043
arm group label: Treatment group
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
url: http://www.mystudywindow.com
description: Related Info
responsible party type: Sponsor
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, except for the following exclusions:
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 (because of limitations with anonymization).
For more details refer to: http://trials.boehringer-ingelheim.com/
submitted: July 5, 2023