<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/NCT04445090</url>
  </required_header>
  <id_info>
    <org_study_id>1447-0001</org_study_id>
    <secondary_id>2019-004836-51</secondary_id>
    <nct_id>NCT04445090</nct_id>
  </id_info>
  <brief_title>A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood</brief_title>
  <official_title>Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1569912 in Healthy Male Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design) With an Additional Relative Bioavailability/ Food Effect Part (Open-label, Randomized, Three-way Crossover Design)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      SRD-Part: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics&#xD;
      following single rising doses (SRD) of BI 1569912 BA/FE-Part: To investigate (a) the relative&#xD;
      bioavailability (BA) of BI 1569912 and (b) the influence of food (FE) on the relative&#xD;
      bioavailability of BI 1569912&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Identification of potential mutagenic metabolite in human plasma&#xD;
  </why_stopped>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Actual">September 10, 2021</completion_date>
  <primary_completion_date type="Actual">September 10, 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>
    <intervention_model_description>SRD-Part: parallel-group design BA/FE-Part: three-way crossover design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SRD-part: % of subjects with drug-related adverse events</measure>
    <time_frame>up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>BA/FE-part: AUC0-tz (area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to the last quantifiable data point)</measure>
    <time_frame>up to 4 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>BA/FE-part: Cmax (maximum measured concentration of BI 1569912 in plasma)</measure>
    <time_frame>up to 4 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>SRD-Part: AUC0-∞ (area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 4 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SRD-Part: Cmax (maximum measured concentration of BI 1569912 in plasma)</measure>
    <time_frame>up to 4 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BA/FE-Part: AUC0-∞ (area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 4 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Single Rising Dose part: BI 1569912</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Rising Dose part: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Bioavailability and Food effect part: BI 1569912</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This part follows the SRD part; open-label, randomised, single-dose, intraindividual, six-sequence, three-way crossover</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1569912</intervention_name>
    <description>BI 1569912</description>
    <arm_group_label>Bioavailability and Food effect part: BI 1569912</arm_group_label>
    <arm_group_label>Single Rising Dose part: BI 1569912</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Single Rising Dose part: Placebo</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 (blood pressure&#xD;
             (BP), pulse rate (PR), respiratory rate (RR), temperature (T)), 12-lead ECG, and&#xD;
             clinical laboratory tests&#xD;
&#xD;
          -  Age of 18 to 45 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. any of the following methods (of female&#xD;
                  partners) plus condom: implants, injectables, combined oral or vaginal&#xD;
                  contraceptives, intrauterine device&#xD;
&#xD;
               -  Sexually abstinent&#xD;
&#xD;
               -  Surgically sterilised (including hysterectomy of female partner)&#xD;
&#xD;
               -  Postmenopausal female partner, defined as at least 1 year of spontaneous&#xD;
                  amenorrhea (in questionable cases a blood sample with follicle stimulating&#xD;
                  hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)&#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 50 to 90 bpm&#xD;
&#xD;
          -  Any laboratory value outside the reference range that the investigator considers to be&#xD;
             of clinical relevance, in particular, hepatic parameters (alanine aminotransferase&#xD;
             (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters&#xD;
             (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements&#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;
          -  History of relevant orthostatic hypotension, fainting spells, or any unexplained&#xD;
             blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  A positive polymerase chain reaction (PCR) test for SARS-CoV-2/COVID-19 and/ or any&#xD;
             clinical symptom suggestive for this disease at screening and on Day -3.&#xD;
&#xD;
        Further exclusion criteria apply.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>November 11, 2021</last_update_submitted>
  <last_update_submitted_qc>November 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 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;
1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).&#xD;
For more details refer to: https://www.mystudywindow.com/msw/datasharing</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/NCT04445090
org study id: 1447-0001
secondary id: 2019-004836-51
nct id: NCT04445090
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
SRD-Part: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics
      following single rising doses (SRD) of BI 1569912 BA/FE-Part: To investigate (a) the relative
      bioavailability (BA) of BI 1569912 and (b) the influence of food (FE) on the relative
      bioavailability of BI 1569912
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: SRD-Part: parallel-group design BA/FE-Part: three-way crossover design
primary purpose: Treatment
masking: Single (Participant)
measure: SRD-part: % of subjects with drug-related adverse events
time frame: up to 14 days
measure: BA/FE-part: AUC0-tz (area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to the last quantifiable data point)
time frame: up to 4 days
measure: BA/FE-part: Cmax (maximum measured concentration of BI 1569912 in plasma)
time frame: up to 4 days
measure: SRD-Part: AUC0-∞ (area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 4 days
measure: SRD-Part: Cmax (maximum measured concentration of BI 1569912 in plasma)
time frame: up to 4 days
measure: BA/FE-Part: AUC0-∞ (area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 4 days
arm group label: Single Rising Dose part: BI 1569912
arm group type: Experimental
arm group label: Single Rising Dose part: Placebo
arm group type: Placebo Comparator
arm group label: Bioavailability and Food effect part: BI 1569912
arm group type: Experimental
description: This part follows the SRD part; open-label, randomised, single-dose, intraindividual, six-sequence, three-way crossover
intervention type: Drug
intervention name: BI 1569912
description: BI 1569912
arm group label: Bioavailability and Food effect part: BI 1569912
arm group label: Single Rising Dose part: BI 1569912
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Single Rising Dose part: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
url: https://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:
1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datasharing