<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/NCT03783000</url>
  </required_header>
  <id_info>
    <org_study_id>1346-0015</org_study_id>
    <secondary_id>2018-001194-24</secondary_id>
    <nct_id>NCT03783000</nct_id>
  </id_info>
  <brief_title>A Study in Healthy Men to Measure the Amount of BI 425809 in the Blood When Taken as a Tablet</brief_title>
  <official_title>Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 425809 Administered as an Oral Dose With an Intravenous Microtracer Dose of [C-14]-BI 425809 in Healthy Male Volunteers</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 primary objective of this trial is to investigate the absolute oral bioavailability of BI&#xD;
      425809 administered as tablet (Test, T) compared to [C-14]-BI 425809 administered as&#xD;
      intravenous microtracer (Reference, R).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">March 6, 2019</completion_date>
  <primary_completion_date type="Actual">March 6, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-∞ (area under the concentration-time curve of the analyte over the time interval from 0 to infinity)</measure>
    <time_frame>Up to 168 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>Up to 168 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>All subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment T followed by Treatment R</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 425809</intervention_name>
    <description>Treatment T</description>
    <arm_group_label>All subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 425809 mixed with [C-14]-BI 425809</intervention_name>
    <description>Treatment R</description>
    <arm_group_label>All subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects according to the assessment of the investigator, 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;
          -  Age of 18 to 65 years (incl.)&#xD;
&#xD;
          -  Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice (GCP) and local legislation&#xD;
&#xD;
          -  Subjects who are sexually active must use, with their partner, highly effective&#xD;
             contraception from the time of administration of trial medication until 4 months after&#xD;
             administration of trial medication. Adequate methods are:&#xD;
&#xD;
               -  Condoms plus use of hormonal contraception by the female partner that started at&#xD;
                  least 2 months prior to administration of trial medication (e.g., implants,&#xD;
                  injectables, combined oral or vaginal contraceptives, intrauterine device) or&#xD;
&#xD;
               -  Condoms plus surgical sterilization (vasectomy at least 1 year prior to&#xD;
                  enrolment) or&#xD;
&#xD;
               -  Condoms plus surgically sterilised partner (including hysterectomy) or&#xD;
&#xD;
               -  Condoms plus intrauterine device or&#xD;
&#xD;
               -  Condoms plus partner of non-childbearing potential (including homosexual men)&#xD;
                  Subjects are required to use condoms to prevent unintended exposure of the&#xD;
                  partner to the study drug via seminal fluid.&#xD;
&#xD;
               -  Alternatively, true abstinence is acceptable when it is in line with the&#xD;
                  subject's preferred and usual lifestyle. If a subject is usually not sexually&#xD;
                  active but becomes active, with their partner, they must comply with the&#xD;
                  contraceptive requirements detailed above.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR)&#xD;
             or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant&#xD;
             by the investigator&#xD;
&#xD;
          -  Repeated measurement of systolic blood pressure outside the range of 90 to 139 mmHg,&#xD;
             diastolic blood pressure outside the range of 45 to 89 mmHg, or pulse rate outside the&#xD;
             range of 40 to 100 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 judged as clinically relevant by the&#xD;
             investigator&#xD;
&#xD;
          -  Clinically significant gastrointestinal, hepatic, renal, respiratory (including but&#xD;
             not limited to interstitial lung disease), cardiovascular, metabolic, immunological or&#xD;
             hormonal disorders&#xD;
&#xD;
          -  Further exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>PRA Health Sciences Onderzoekscentrum Martini</name>
      <address>
        <city>Groningen</city>
        <zip>9728 NZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</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>BI 425809</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, 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). For more details refer to: http://trials.boehringer-ingelheim.com/</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/NCT03783000
org study id: 1346-0015
secondary id: 2018-001194-24
nct id: NCT03783000
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this trial is to investigate the absolute oral bioavailability of BI
      425809 administered as tablet (Test, T) compared to [C-14]-BI 425809 administered as
      intravenous microtracer (Reference, R).
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-∞ (area under the concentration-time curve of the analyte over the time interval from 0 to infinity)
time frame: Up to 168 hours
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: Up to 168 hours
arm group label: All subjects
arm group type: Experimental
description: Treatment T followed by Treatment R
intervention type: Drug
intervention name: BI 425809
description: Treatment T
arm group label: All subjects
intervention type: Drug
intervention name: BI 425809 mixed with [C-14]-BI 425809
description: Treatment R
arm group label: All subjects
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: BI 425809
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: http://trials.boehringer-ingelheim.com/