<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/NCT03259464</url>
  </required_header>
  <id_info>
    <org_study_id>1366-0013</org_study_id>
    <nct_id>NCT03259464</nct_id>
  </id_info>
  <brief_title>This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated</brief_title>
  <official_title>Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 685509 in Healthy Chinese and Japanese Male Volunteers (Randomised, Single-blind, Placebo-controlled Trial)</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>
      The primary objective of this trial is to investigate the safety and tolerability of BI&#xD;
      685509 in healthy male subjects following oral administration of multiple rising doses.&#xD;
&#xD;
      Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics&#xD;
      (PD) of BI 685509 in healthy Chinese and Japanese subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Actual">May 26, 2018</completion_date>
  <primary_completion_date type="Actual">May 26, 2018</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>Number [N (%)] of subjects with drug-related Adverse Events (AEs)</measure>
    <time_frame>up to day 35</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>After the first dose:AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h)</measure>
    <time_frame>up to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>After the first dose:Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>After the drug administration on Day 10 and Day 17 of DGs 1-2: AUCtau,ss (area under the concentration-time curve of the analyte in plasma over the dosing interval tau at steady state) [AUCtau,ss will be AUC0-12,ss for b.i.d. and AUC0-24,ss for q.d.]</measure>
    <time_frame>Dose Group (DG) 1: up to 240 hours &amp; up to 408 hours DG2: up to 240 hours &amp; up to 396 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>After the drug administration on Day 10 and Day 17 of DGs 1-2: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)</measure>
    <time_frame>Dose Group (DG) 1: up to 240 hours &amp; up to 408 hours DG2: up to 240 hours &amp; up to 396 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 685509</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chinese &amp; Japanese subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Chinese &amp; Japanese subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 685509</intervention_name>
    <description>3 sequential dose groups</description>
    <arm_group_label>BI 685509</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>3 sequential dose groups</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Healthy male subjects according to the investigator's assessment, based on a complete&#xD;
             medical history including a physical examination, vital signs (Blood pressure (BP),&#xD;
             Pulse rate (PR), 12-lead Electrocardiogram (ECG), and clinical laboratory tests&#xD;
&#xD;
          -  Chinese or Japanese ethnicity, according to the following criteria:&#xD;
&#xD;
               -  Chinese; born in China or ethnic Chinese born outside of China, and a descendent&#xD;
                  of 4 ethnic Chinese grandparents who were all born in China&#xD;
&#xD;
               -  Japanese; born in Japan, have lived outside of Japan &lt;10 years, and have parents&#xD;
                  and grandparents who are Japanese&#xD;
&#xD;
          -  Age of 20 to 45 years (incl.)&#xD;
&#xD;
          -  Body mass index (BMI) range: ≥18.5 and &lt;25.0 kg/m2&#xD;
&#xD;
          -  Signed and dated written informed consent by date of Visit 1 in accordance with Good&#xD;
             Clinical Practice (GCP) and local legislation.&#xD;
&#xD;
          -  Male subjects who agree to minimize the risk of female partners becoming pregnant by&#xD;
             fulfilling any of the following criteria starting from at least 30 days before the&#xD;
             first administration of trial medication and until 90 days after trial completion:&#xD;
&#xD;
               -  Use of adequate contraception, e.g. any of the following methods plus condom:&#xD;
                  combined oral contraceptives, intrauterine device&#xD;
&#xD;
               -  Vasectomised (vasectomy at least 1 year prior to enrolment)&#xD;
&#xD;
               -  Surgically sterilised (including hysterectomy) female partner&#xD;
&#xD;
               -  Sexually abstinent&#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;
          -  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;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Surgery of the gastrointestinal tract that could interfere with kinetics of the trial&#xD;
             medication (except appendectomy and simple 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 including HIV, viral hepatitis and (or)&#xD;
             tuberculosis or evidence of tuberculosis infection as defined by a positive&#xD;
             QuantiFERON TB-Gold (or TSPOT) test. Subjects with a positive QuantiFERON TB-Gold (or&#xD;
             T-SPOT) test will not participate in the study. The HBV carriers and subjects with&#xD;
             history of HB (including the subjects with only HBs antibody positive [negative for&#xD;
             both HBs antigen and HBc antibody] and without HB vaccination) will not be allowed to&#xD;
             participate in this trial.&#xD;
&#xD;
          -  History of relevant allergy or hypersensitivity (including allergy to the trial&#xD;
             medication or its excipients)&#xD;
&#xD;
          -  Intake of biologic agents other than current study medication or drugs considered&#xD;
             likely to interfere with the safe conduct of the study&#xD;
&#xD;
          -  Within 30 days prior to administration of trial medication, use of drugs that might&#xD;
             reasonably influence the results of the trial or that might prolong the QT/QTc&#xD;
             interval&#xD;
&#xD;
          -  Participation in another trial (including bioequivalence trial) with an&#xD;
             investigational drug within 90 days or 5 half-lives (whichever is greater) prior to&#xD;
             planned administration of trial medication&#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 30 g per day)&#xD;
&#xD;
          -  Drug abuse or positive drug screening&#xD;
&#xD;
          -  Blood donation of more than 200 mL within 30 days or 400 mL within 12 weeks prior to&#xD;
             administration of trial medication or intended donation during the trial&#xD;
&#xD;
          -  Intention to perform excessive physical activities within one week prior to&#xD;
             administration of trial medication or during the trial&#xD;
&#xD;
          -  Inability to comply with dietary regimen of trial site&#xD;
&#xD;
          -  A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are&#xD;
             repeatedly greater than 450 ms) or any other relevant ECG finding at screening&#xD;
&#xD;
          -  A history of additional risk factors for Torsades de Pointes (such as heart failure,&#xD;
             hypokalemia, or family history of Long QT Syndrome)&#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;
          -  Have received any live bacterial or live viral vaccination in the 12 weeks prior to&#xD;
             the date of screening. Subjects must agree not to receive a live bacterial or live&#xD;
             viral vaccination during the study and up to 12 months after the last administration&#xD;
             of study drug&#xD;
&#xD;
          -  Have received Bacille Calmette-Guerin (BCG) vaccination in the 12 months prior to the&#xD;
             date of screening. Subjects must agree not to receive BCG vaccination during the study&#xD;
             and up to 12 months after the last administration of study drug&#xD;
&#xD;
          -  Subject is assessed as unsuitable for inclusion by the investigator, for instance,&#xD;
             because considered not able to understand and comply with study requirements, or has a&#xD;
             condition that would not allow safe participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SOUSEIKAI Sumida Hospital</name>
      <address>
        <city>Tokyo, Sumida-ku</city>
        <zip>133-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>July 3, 2018</last_update_submitted>
  <last_update_submitted_qc>July 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03259464
org study id: 1366-0013
nct id: NCT03259464
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary objective of this trial is to investigate the safety and tolerability of BI
      685509 in healthy male subjects following oral administration of multiple rising doses.

      Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics
      (PD) of BI 685509 in healthy Chinese and Japanese subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number [N (%)] of subjects with drug-related Adverse Events (AEs)
time frame: up to day 35
measure: After the first dose:AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h)
time frame: up to 24 hours
measure: After the first dose:Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 72 hours
measure: After the drug administration on Day 10 and Day 17 of DGs 1-2: AUCtau,ss (area under the concentration-time curve of the analyte in plasma over the dosing interval tau at steady state) [AUCtau,ss will be AUC0-12,ss for b.i.d. and AUC0-24,ss for q.d.]
time frame: Dose Group (DG) 1: up to 240 hours & up to 408 hours DG2: up to 240 hours & up to 396 hours
measure: After the drug administration on Day 10 and Day 17 of DGs 1-2: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
time frame: Dose Group (DG) 1: up to 240 hours & up to 408 hours DG2: up to 240 hours & up to 396 hours
arm group label: BI 685509
arm group type: Experimental
description: Chinese & Japanese subjects
arm group label: Placebo
arm group type: Placebo Comparator
description: Chinese & Japanese subjects
intervention type: Drug
intervention name: BI 685509
description: 3 sequential dose groups
arm group label: BI 685509
intervention type: Drug
intervention name: Placebo
description: 3 sequential dose groups
arm group label: Placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Japan
country: Korea, Republic of
responsible party type: Sponsor