<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/NCT04426851</url>
  </required_header>
  <id_info>
    <org_study_id>1402-0016</org_study_id>
    <secondary_id>2020-000351-13</secondary_id>
    <nct_id>NCT04426851</nct_id>
  </id_info>
  <brief_title>A Study in Healthy Men to Test How BI 1358894 is Taken up in the Body and How Food Influences the Amount of BI 1358894 in the Blood</brief_title>
  <official_title>Investigation of Pharmacokinetics and Absolute Bioavailability of BI 1358894 Administered Orally as Tablet Co-administered With an Intravenous Microtracer Dose of [C-14]-BI 1358894 in Healthy Male Volunteers Via a Non-randomised, Open-label, Fixed-sequence Trial (Part 1) Followed by a Randomised, Open-label, Single-dose, Two-period, Two-sequence Cross-over Relative Bioavailability Trial in BI 1358894 Oral Suspension (Part 2)</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 objective of Part 1 of this trial is to investigate the absolute bioavailability of&#xD;
      BI 1358894 with an intravenous microdose formulation containing labelled [C-14] BI 1358894&#xD;
      and an unlabelled oral tablet formulation of BI 1358894 in healthy male subjects.&#xD;
&#xD;
      The main objective of Part 2 of this trial is to investigate the relative bioavailability of&#xD;
      BI 1358894 administered as an oral suspension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Actual">October 12, 2020</completion_date>
  <primary_completion_date type="Actual">October 12, 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Part 1: non-randomized, fixed-sequence design Part 2: randomized, two-period, two-sequence, crossover design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part 1: AUC 0-inf (area under the concentration-time curve of the analyte over the time interval from 0 to infinity after intravenous (iv) administration) for (C-14) BI 1358894 iv</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: AUC 0-inf (area under the concentration-time curve of the analyte over the time interval from 0 to infinity after oral (po) administration) for BI 1358894 po</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: AUC 0-312 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 312 h)</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 1: Cmax (maximum measured concentration of the analyte after oral administration)</measure>
    <time_frame>Up to 14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Cmax (maximum measured concentration of the analyte after oral administration)</measure>
    <time_frame>Up to 14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after oral administration)</measure>
    <time_frame>Up to 14 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Part 2: BI 1358894 (Test 2-Reference 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 1358894</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: BI 1358894 (Reference 2-Test 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 1358894</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: BI 1358894 (Test 1-Reference 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 1358894</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1358894</intervention_name>
    <description>BI 1358894</description>
    <arm_group_label>Part 1: BI 1358894 (Test 1-Reference 1)</arm_group_label>
    <arm_group_label>Part 2: BI 1358894 (Reference 2-Test 2)</arm_group_label>
    <arm_group_label>Part 2: BI 1358894 (Test 2-Reference 2)</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 55 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 90 days after trial completion:&#xD;
&#xD;
          -  Use of adequate contraception of the female partner, e.g. any of the following methods&#xD;
             plus condom: implants, injectables, combined oral or vaginal contraceptives,&#xD;
             intrauterine device that started at least 2 months prior to first study drug&#xD;
             administration or barrier method (e.g. diaphragm with spermicide) or,&#xD;
&#xD;
          -  Sexually abstinent or&#xD;
&#xD;
          -  A vasectomy performed at least 1 year prior to screening (with medical assessment of&#xD;
             the surgical success) or&#xD;
&#xD;
          -  Surgically sterilised female partner (including hysterectomy, bilateral tubal&#xD;
             occlusion or bilateral oophorectomy) or&#xD;
&#xD;
          -  Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea&#xD;
             (in questionable cases a blood sample with FSH (follicle stimulating hormone) above 40&#xD;
             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 40 to 100 bpm&#xD;
&#xD;
          -  C-reactive protein (CRP) &gt; upper limit of normal (ULN), liver or kidney parameter&#xD;
             above ULN&#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;
          -  Further exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 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>October 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>October 28, 2020</last_update_submitted>
  <last_update_submitted_qc>October 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2020</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>
  <!-- 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/NCT04426851
org study id: 1402-0016
secondary id: 2020-000351-13
nct id: NCT04426851
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of Part 1 of this trial is to investigate the absolute bioavailability of
      BI 1358894 with an intravenous microdose formulation containing labelled [C-14] BI 1358894
      and an unlabelled oral tablet formulation of BI 1358894 in healthy male subjects.

      The main objective of Part 2 of this trial is to investigate the relative bioavailability of
      BI 1358894 administered as an oral suspension.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Part 1: non-randomized, fixed-sequence design Part 2: randomized, two-period, two-sequence, crossover design
primary purpose: Treatment
masking: None (Open Label)
measure: Part 1: AUC 0-inf (area under the concentration-time curve of the analyte over the time interval from 0 to infinity after intravenous (iv) administration) for (C-14) BI 1358894 iv
time frame: Up to 14 days
measure: Part 1: AUC 0-inf (area under the concentration-time curve of the analyte over the time interval from 0 to infinity after oral (po) administration) for BI 1358894 po
time frame: Up to 14 days
measure: Part 2: AUC 0-312 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 312 h)
time frame: Up to 14 days
measure: Part 1: Cmax (maximum measured concentration of the analyte after oral administration)
time frame: Up to 14 days
measure: Part 2: Cmax (maximum measured concentration of the analyte after oral administration)
time frame: Up to 14 days
measure: Part 2: AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after oral administration)
time frame: Up to 14 days
arm group label: Part 2: BI 1358894 (Test 2-Reference 2)
arm group type: Experimental
description: BI 1358894
arm group label: Part 2: BI 1358894 (Reference 2-Test 2)
arm group type: Experimental
description: BI 1358894
arm group label: Part 1: BI 1358894 (Test 1-Reference 1)
arm group type: Experimental
description: BI 1358894
intervention type: Drug
intervention name: BI 1358894
description: BI 1358894
arm group label: Part 1: BI 1358894 (Test 1-Reference 1)
arm group label: Part 2: BI 1358894 (Reference 2-Test 2)
arm group label: Part 2: BI 1358894 (Test 2-Reference 2)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Netherlands
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/