<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/NCT02254109</url>
  </required_header>
  <id_info>
    <org_study_id>1205.18</org_study_id>
    <nct_id>NCT02254109</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising of BEA 2180 BR in Japanese Healthy Male Volunteers</brief_title>
  <official_title>A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhalative Doses (50 μg, 100 μg and 200 μg q.d. for 14 Days) of BEA 2180 BR in Japanese Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese&#xD;
      healthy volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2008</start_date>
  <primary_completion_date type="Actual">October 2008</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 abnormal findings in physical examination</measure>
    <time_frame>up to 28 days after last dose administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in vital signs</measure>
    <time_frame>up to 28 days after last dose administration</time_frame>
    <description>Blood pressure and pulse rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in 12-lead electrocardiogram (ECG)</measure>
    <time_frame>up to 28 days after last dose administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 28 days after last dose administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 28 days after last dose administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of tolerability by the investigator on a 4-point scale</measure>
    <time_frame>28 days after last dose administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCτ (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aeτ (amount of analyte that is eliminated in urine over a uniform dosing interval τ)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>feτ (fraction of analyte eliminated in urine over a uniform dosing interval τ)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin,ss (minimum concentration of the analyte in plasma at steady state)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz,ss (terminal rate constant in plasma at steady state)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2,ss (terminal half-life of the analyte in plasma at steady state)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTih,ss (mean residence time of the analyte in the body at steady state after inhalation administration)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio of the analyte in plasma based on Cmax (RA,Cmax)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio of the analyte in plasma based on AUC (RA,AUC)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio of the analyte in plasma based on Ae (RA,Ae)</measure>
    <time_frame>up to 648:00 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BEA 2180 BR - rising dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BEA 2180 BR - rising dose</intervention_name>
    <arm_group_label>BEA 2180 BR - rising dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy Japanese men:&#xD;
&#xD;
             According to the results of a complete medical history, the physical examination,&#xD;
             vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory tests&#xD;
&#xD;
          2. Age ≥20 and ≤35 years&#xD;
&#xD;
          3. Body mass index (BMI) ≥18.5 and ≤25 kg/m2&#xD;
&#xD;
          4. Subjects must be able to inhale medication in a competent manner from the Respimat®&#xD;
&#xD;
          5. Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice (GCP)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any finding of the medical examination (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          2. Any evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          4. Surgery of the gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          6. History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          7. Chronic or relevant acute infections&#xD;
&#xD;
          8. History of relevant allergy/hypersensitivity including allergy to drug or its&#xD;
             excipients&#xD;
&#xD;
          9. Intake of drugs with a long half-life (&gt;24 hours) within one month or less than 10&#xD;
             half-lives of the respective drug before drug administration or during the trial&#xD;
&#xD;
         10. Use of prescription or non-prescription drugs within 10 days before drug&#xD;
             Administration or during the trial. However, over-the-counter (OTC) drugs for external&#xD;
             application (such as lubricant eye drops for contact lens, insect bite reliever) shall&#xD;
             be allowed&#xD;
&#xD;
         11. Participation in another trial with an investigational drug within four months before&#xD;
             drug administration or during the trial&#xD;
&#xD;
         12. Smoker (&gt;10 cigarettes or &gt;3 cigars or &gt;3 pipes/day)&#xD;
&#xD;
         13. Inability to refrain from smoking during the trial&#xD;
&#xD;
         14. Alcohol abuse (≥60 g/day: corresponds to ca. 3 large bottles of beer, 3 gous (ca. 540&#xD;
             cc) of Japanese sake, 6 shots of whisky, 6 glasses of wine or 6 glasses of Japanese&#xD;
             shochu, distilled alcoholic beverage)&#xD;
&#xD;
         15. Drug abuse&#xD;
&#xD;
         16. Blood donation (≥100 mL within four weeks before drug administration or during the&#xD;
             trial)&#xD;
&#xD;
         17. Excessive physical activities (within one week before drug administration or during&#xD;
             the trial)&#xD;
&#xD;
         18. Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
         19. Inability to comply with dietary regimen of trial site&#xD;
&#xD;
             Exclusion criteria specific for this study:&#xD;
&#xD;
         20. Occupational (professional) exposure to antimuscarinic substances (e.g., physician,&#xD;
             nurse, pharmacist etc.; volunteers working for medical institutions, research&#xD;
             institutions or herb gardens)&#xD;
&#xD;
         21. History of glaucoma, urination difficulty (due to prostatic hyperplasia etc.)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 30, 2014</last_update_submitted>
  <last_update_submitted_qc>September 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 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/NCT02254109
org study id: 1205.18
nct id: NCT02254109
lead sponsor: 
Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese
      healthy volunteers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of subjects with abnormal findings in physical examination
time frame: up to 28 days after last dose administration
measure: Number of subjects with clinically significant changes in vital signs
time frame: up to 28 days after last dose administration
description: Blood pressure and pulse rate
measure: Number of subjects with clinically significant changes in 12-lead electrocardiogram (ECG)
time frame: up to 28 days after last dose administration
measure: Number of subjects with abnormal changes in laboratory parameters
time frame: up to 28 days after last dose administration
measure: Number of subjects with adverse events
time frame: up to 28 days after last dose administration
measure: Assessment of tolerability by the investigator on a 4-point scale
time frame: 28 days after last dose administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 648:00 hours
measure: tmax (time from dosing to maximum measured concentration of the analyte in plasma)
time frame: up to 648:00 hours
measure: AUCτ (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ)
time frame: up to 648:00 hours
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz)
time frame: up to 648:00 hours
measure: Aeτ (amount of analyte that is eliminated in urine over a uniform dosing interval τ)
time frame: up to 648:00 hours
measure: feτ (fraction of analyte eliminated in urine over a uniform dosing interval τ)
time frame: up to 648:00 hours
measure: CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
time frame: up to 648:00 hours
measure: Cmin,ss (minimum concentration of the analyte in plasma at steady state)
time frame: up to 648:00 hours
measure: Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
time frame: up to 648:00 hours
measure: λz,ss (terminal rate constant in plasma at steady state)
time frame: up to 648:00 hours
measure: t1/2,ss (terminal half-life of the analyte in plasma at steady state)
time frame: up to 648:00 hours
measure: MRTih,ss (mean residence time of the analyte in the body at steady state after inhalation administration)
time frame: up to 648:00 hours
measure: CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)
time frame: up to 648:00 hours
measure: Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
time frame: up to 648:00 hours
measure: Accumulation ratio of the analyte in plasma based on Cmax (RA,Cmax)
time frame: up to 648:00 hours
measure: Accumulation ratio of the analyte in plasma based on AUC (RA,AUC)
time frame: up to 648:00 hours
measure: Accumulation ratio of the analyte in plasma based on Ae (RA,Ae)
time frame: up to 648:00 hours
arm group label: BEA 2180 BR - rising dose
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BEA 2180 BR - rising dose
arm group label: BEA 2180 BR - rising dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor