<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/NCT02183545</url>
  </required_header>
  <id_info>
    <org_study_id>1333.3</org_study_id>
    <nct_id>NCT02183545</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1060469 in Healthy Asian Male Volunteers</brief_title>
  <official_title>Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1060469 in Healthy Asian Male Volunteers in a Randomized, Double-blind, Placebo-controlled Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objective of this single rising dose study (SRD) is to investigate safety, tolerability,&#xD;
      and pharmacokinetics of single rising doses of BI 1060469 in healthy Asian male subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of subjects with drug-related adverse events</measure>
    <time_frame>up to 14 days after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration of BI 1060469 (Cmax)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the concentration-time curve of BI 1060469 over time interval from 0 interpolated to infinity ((AUC0-infinity)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the concentration-time curve of BI 1060469 (AUC0- tz)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 1060469</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single rising doses given as tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>given as tablet (matching placebo of BI 1060469)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1060469</intervention_name>
    <description>single rising doses given as tablet</description>
    <arm_group_label>BI 1060469</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>given as tablet (matching placebo of BI 1060469)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Healthy males based upon a complete medical history, including a physical examination,&#xD;
             vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests&#xD;
&#xD;
          2. Chinese ethnicity, Japanese ethnicity according to the following criteria:&#xD;
&#xD;
             Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4&#xD;
             ethnic Chinese grandparents who were all born in china Japanese; born in Japan, have&#xD;
             lived outside of Japan &lt;10 years, and have parents and grandparents who were all born&#xD;
             in Japan&#xD;
&#xD;
          3. Age within the range of 18 to 45 years&#xD;
&#xD;
          4. Body mass index within the range of 18.5 and 25 kg/m2&#xD;
&#xD;
          5. 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;
        Exclusion criteria:&#xD;
&#xD;
          1. Any finding in the medical examination (including blood pressure, pulse rate or&#xD;
             ECG(electrocardiogram)) deviating from normal and judged clinically relevant by the&#xD;
             investigator. Pulse rate outside the range of 50-90 beat per minute or blood pressure&#xD;
             outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure&#xD;
             if confirmed by repeat measurement.&#xD;
&#xD;
          2. Any laboratory value outside the reference range that the investigator considers to be&#xD;
             of clinical relevance&#xD;
&#xD;
          3. Serum creatinine laboratory value outside the normal range&#xD;
&#xD;
          4. Glomerular Filtration Rate according to CKD-EPI (Chronic Kidney Disease Epidemiology&#xD;
             Collaboration) Formula &lt; 60 ml/ min&#xD;
&#xD;
          5. Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e.&#xD;
             nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal&#xD;
             failure, infections)&#xD;
&#xD;
          6. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          7. Surgery of the gastrointestinal tract that could interfere with kinetics of the study&#xD;
             drug&#xD;
&#xD;
          8. Diseases of the central nervous system (such as epilepsy), central neurological&#xD;
             disorders or psychiatric disorders&#xD;
&#xD;
          9. History of relevant orthostatic hypotension, fainting spells, or blackouts&#xD;
&#xD;
         10. Relevant chronic or acute infections&#xD;
&#xD;
         11. History of relevant allergy/hypersensitivity (including allergy to the trial&#xD;
             medication or its excipients)&#xD;
&#xD;
         12. Intake of drugs with a long half-life (greater than 24 hours) within 30 days or less&#xD;
             than 10 half-lives of the respective drug prior to study drug administration&#xD;
&#xD;
         13. Intake of any NSAIDs(Nonsteroidal anti-inflammatory drugs), COX2(Cyclooxygenase-2)&#xD;
             inhibitors, aspirin, ACE(Angiotensin Converting Enzyme) inhibitors, H2-blockers or&#xD;
             OTC(Over the Counter Drug)- or nutripharmaceuticals between screening examination and&#xD;
             drug administration&#xD;
&#xD;
         14. Use of drugs that might reasonably influence the results of the trial (including renal&#xD;
             function measurements) or that might prolong the QT/QTc interval within 14 days prior&#xD;
             to study drug administration&#xD;
&#xD;
         15. Participation in another trial with investigational drug administration within 60 days&#xD;
             prior to administration of trial medication&#xD;
&#xD;
         16. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)&#xD;
&#xD;
         17. Inability to refrain from smoking on specified trial days&#xD;
&#xD;
         18. Alcohol abuse (consumption of more than 30 g/day)&#xD;
&#xD;
         19. Drug abuse or positive drug screen&#xD;
&#xD;
         20. Blood donation (more than 100 mL within 30 days prior to administration of trial&#xD;
             medication or intended during the trial)&#xD;
&#xD;
         21. Intention to perform excessive physical activities within one week prior to&#xD;
             administration of trial medication or during the trial&#xD;
&#xD;
         22. Inability to comply with dietary regimen of trial site&#xD;
&#xD;
         23. A marked baseline prolongation of QT/QTc interval (such as repeated demonstration of a&#xD;
             QTc interval greater than 450 ms) or any other relevant ECG finding&#xD;
&#xD;
         24. 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;
         25. Subject is assessed by the investigator as unsuitable for inclusion, 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>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1333.3.82002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1333.3.82001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2014</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/NCT02183545
org study id: 1333.3
nct id: NCT02183545
lead sponsor: 
The objective of this single rising dose study (SRD) is to investigate safety, tolerability,
      and pharmacokinetics of single rising doses of BI 1060469 in healthy Asian male subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: number of subjects with drug-related adverse events
time frame: up to 14 days after drug administration
measure: Maximum concentration of BI 1060469 (Cmax)
time frame: up to 72 hours after drug administration
measure: Area Under the concentration-time curve of BI 1060469 over time interval from 0 interpolated to infinity ((AUC0-infinity)
time frame: up to 72 hours after drug administration
measure: Area Under the concentration-time curve of BI 1060469 (AUC0- tz)
time frame: up to 72 hours after drug administration
arm group label: BI 1060469
arm group type: Experimental
description: single rising doses given as tablet
arm group label: Placebo
arm group type: Placebo Comparator
description: given as tablet (matching placebo of BI 1060469)
intervention type: Drug
intervention name: BI 1060469
description: single rising doses given as tablet
arm group label: BI 1060469
intervention type: Drug
intervention name: Placebo
description: given as tablet (matching placebo of BI 1060469)
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor