<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/NCT03817476</url>
  </required_header>
  <id_info>
    <org_study_id>1346-0019</org_study_id>
    <secondary_id>2018-003625-29</secondary_id>
    <nct_id>NCT03817476</nct_id>
  </id_info>
  <brief_title>A Study in Healthy People to Test if Taking Different Formulations of BI 425809 Tablets Influences the Amount of BI 425809 in the Blood</brief_title>
  <official_title>Relative Bioavailability of Batch 1 and Batch 2 of the Intended Commercial Formulation of BI 425809 Compared to Each Other and to TF 2 Formulation of BI 425809 Following Oral Administration in Healthy Male and Female Subjects (Randomized, Open-label, Single-dose, Three-treatment, Three-period, Six-sequence Crossover Study)</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 this trial is to investigate the relative bioavailability of batch 1 of&#xD;
      the intended commercial tablet formulation (iCF1) of BI 425809 vs batch 2 of the intended&#xD;
      commercial tablet formulation (iCF2) of BI 425809 vs BI 425809 (TF2) formulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Actual">May 28, 2019</completion_date>
  <primary_completion_date type="Actual">May 28, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-72 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 h)</measure>
    <time_frame>Up to 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>Up to 72 hours</time_frame>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>T1-T2-R</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>T1-R-T2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>T2-T1-R</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>T2-R-T1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>R-T1-T2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>R-T2-T1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 425809 (Treatment T1)</intervention_name>
    <description>Intended commercial formulation tablet from batch 1 (iCF1)</description>
    <arm_group_label>R-T1-T2</arm_group_label>
    <arm_group_label>R-T2-T1</arm_group_label>
    <arm_group_label>T1-R-T2</arm_group_label>
    <arm_group_label>T1-T2-R</arm_group_label>
    <arm_group_label>T2-R-T1</arm_group_label>
    <arm_group_label>T2-T1-R</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 425809 (Treatment T2)</intervention_name>
    <description>Intended commercial formulation tablet from batch 2 (iCF2)</description>
    <arm_group_label>R-T1-T2</arm_group_label>
    <arm_group_label>R-T2-T1</arm_group_label>
    <arm_group_label>T1-R-T2</arm_group_label>
    <arm_group_label>T1-T2-R</arm_group_label>
    <arm_group_label>T2-R-T1</arm_group_label>
    <arm_group_label>T2-T1-R</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 425809 (Treatment R)</intervention_name>
    <description>Trial formulation 2 tablet (TF2)</description>
    <arm_group_label>R-T1-T2</arm_group_label>
    <arm_group_label>R-T2-T1</arm_group_label>
    <arm_group_label>T1-R-T2</arm_group_label>
    <arm_group_label>T1-T2-R</arm_group_label>
    <arm_group_label>T2-R-T1</arm_group_label>
    <arm_group_label>T2-T1-R</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female subjects according to the assessment of the investigator, as&#xD;
             based on a complete medical history including a physical examination, vital signs&#xD;
             (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical&#xD;
             laboratory tests&#xD;
&#xD;
          -  Age of 18 to 55 years (inclusive)&#xD;
&#xD;
          -  Body Mass Index (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, or female subjects who meet any of the following criteria from at least&#xD;
             30 days before the first administration of trial medication until 30 days after trial&#xD;
             completion:&#xD;
&#xD;
               -  Use of adequate contraception, e.g. any of the following methods plus condom:&#xD;
&#xD;
                  --- implants, injectables, combined oral or vaginal contraceptives, intrauterine&#xD;
                  device&#xD;
&#xD;
               -  Sexually abstinent&#xD;
&#xD;
               -  A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)&#xD;
&#xD;
               -  Surgically sterilised (including hysterectomy)&#xD;
&#xD;
               -  Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in&#xD;
                  questionable cases a blood sample with levels of FSH above 40 U/L and estradiol&#xD;
                  below 30 ng/L is confirmatory)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR)&#xD;
             or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant&#xD;
             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 beats per minute (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;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of relevant allergy or hypersensitivity (including allergy to the trial&#xD;
             medication or its excipients)&#xD;
&#xD;
          -  Use of drugs within 30 days of planned administration of trial medication that might&#xD;
             reasonably influence the results of the trial (including drugs that cause QT/QTc&#xD;
             interval prolongation)&#xD;
&#xD;
          -  Intake of an investigational drug in another clinical trial within 60 days of planned&#xD;
             administration of investigational drug in the current trial, or concurrent&#xD;
             participation in another clinical trial in which investigational drug is administered&#xD;
&#xD;
          -  Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)&#xD;
&#xD;
          -  Inability to refrain from smoking on specified trial days&#xD;
&#xD;
          -  Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for&#xD;
             males)&#xD;
&#xD;
          -  Drug abuse or positive drug screening&#xD;
&#xD;
          -  Blood donation of more than 100 mL within 30 days of planned administration of trial&#xD;
             medication or intended blood donation during the trial&#xD;
&#xD;
          -  Intention to perform excessive physical activities within one week prior to the&#xD;
             administration of trial medication or during the trial&#xD;
&#xD;
          -  Inability to comply with the dietary regimen of the trial site&#xD;
&#xD;
          -  A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are&#xD;
             repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females)&#xD;
             or any other relevant Electrocardiogram (ECG) finding at screening&#xD;
&#xD;
          -  A history of additional risk factors for Torsade de Pointes (such as heart failure,&#xD;
             hypokalaemia, or family history of Long QT Syndrome)&#xD;
&#xD;
          -  Subject is assessed as unsuitable for inclusion by the investigator, for instance,&#xD;
             because the subject is not considered able to understand and comply with study&#xD;
             requirements, or has a condition that would not allow safe participation in the study&#xD;
&#xD;
          -  Female subjects, only: Positive pregnancy test, pregnancy, or plans to become pregnant&#xD;
             within 30 days after study completion&#xD;
&#xD;
          -  Female subjects, only: Lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Humanpharmakologisches Zentrum Biberach</name>
      <address>
        <city>Biberach</city>
        <zip>88397</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>June 3, 2019</last_update_submitted>
  <last_update_submitted_qc>June 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 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/NCT03817476
org study id: 1346-0019
secondary id: 2018-003625-29
nct id: NCT03817476
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this trial is to investigate the relative bioavailability of batch 1 of
      the intended commercial tablet formulation (iCF1) of BI 425809 vs batch 2 of the intended
      commercial tablet formulation (iCF2) of BI 425809 vs BI 425809 (TF2) formulation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-72 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 h)
time frame: Up to 72 hours
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: Up to 72 hours
arm group label: T1-T2-R
arm group type: Experimental
arm group label: T1-R-T2
arm group type: Experimental
arm group label: T2-T1-R
arm group type: Experimental
arm group label: T2-R-T1
arm group type: Experimental
arm group label: R-T1-T2
arm group type: Experimental
arm group label: R-T2-T1
arm group type: Experimental
intervention type: Drug
intervention name: BI 425809 (Treatment T1)
description: Intended commercial formulation tablet from batch 1 (iCF1)
arm group label: R-T1-T2
arm group label: R-T2-T1
arm group label: T1-R-T2
arm group label: T1-T2-R
arm group label: T2-R-T1
arm group label: T2-T1-R
intervention type: Drug
intervention name: BI 425809 (Treatment T2)
description: Intended commercial formulation tablet from batch 2 (iCF2)
arm group label: R-T1-T2
arm group label: R-T2-T1
arm group label: T1-R-T2
arm group label: T1-T2-R
arm group label: T2-R-T1
arm group label: T2-T1-R
intervention type: Drug
intervention name: BI 425809 (Treatment R)
description: Trial formulation 2 tablet (TF2)
arm group label: R-T1-T2
arm group label: R-T2-T1
arm group label: T1-R-T2
arm group label: T1-T2-R
arm group label: T2-R-T1
arm group label: T2-T1-R
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
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/