<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/NCT02183662</url>
  </required_header>
  <id_info>
    <org_study_id>1277.1</org_study_id>
    <nct_id>NCT02183662</nct_id>
  </id_info>
  <brief_title>Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW in Healthy Male Volunteers.</brief_title>
  <official_title>Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW at 6.2 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg Dose Levels in Healthy Male Volunteers (Randomized, Double-blind, Placebo-controlled Within Dose Groups)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To investigate safety and pharmacokinetics of BI 224436 ZW&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2009</start_date>
  <primary_completion_date type="Actual">March 2010</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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>maximum measured concentration of the analyte in plasma</measure>
    <time_frame>up to 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24</measure>
    <time_frame>up to 24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>minimum observed concentration at 24 hours</measure>
    <time_frame>up to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>terminal half-life of the analyte in plasma</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time from dosing to maximum measured concentration of the analyte in plasma</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>apparent clearance of the analyte in plasma</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>apparent volume of distribution during the terminal phase λz</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>apparent volume of distribution</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean residence time of the analyte in the body after single oral administration</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>terminal rate constant in plasma</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the last measurable concentration in the concentration-time profile</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the extrapolated Area under the curve from the time of the last measurable concentration in the concentration-time profile to infinity</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the percentage of the Area under the concentration-time curve until infinity, that is determined by extrapolation</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>amount of analyte that is eliminated in urine from the time point t0 to time point t4</measure>
    <time_frame>up to 4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>amount of analyte that is eliminated in urine from the time point t4 to time point t8</measure>
    <time_frame>from 4 to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>amount of analyte that is eliminated in urine from the time point t8 to time point t12</measure>
    <time_frame>from 8 to 12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>amount of analyte that is eliminated in urine from the time point t12 to time point t24</measure>
    <time_frame>from 12 to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fraction of analyte eliminated in urine from time point t0 to time point t24</measure>
    <time_frame>up to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>renal clearance of the analyte from the time point t0 until the time point t24</measure>
    <time_frame>up to 24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 224436</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>BI 224436</intervention_name>
    <arm_group_label>BI 224436</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to BI 224436</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males&#xD;
&#xD;
          2. Age ≥21 and Age ≤50 years&#xD;
&#xD;
          3. Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2&#xD;
&#xD;
          4. Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good clinical practice (GCP) and the local legislation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR)&#xD;
             and electrocardiogram (ECG)) 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. HIV infection and other 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 at least one month or less&#xD;
             than 10 half-lives of the respective drug prior to administration or during the trial&#xD;
&#xD;
         10. Use of drugs which might reasonably influence the results of the trial within 10 days&#xD;
             prior to administration or during the trial&#xD;
&#xD;
         11. Participation in another trial with an investigational drug within one month prior to&#xD;
             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 on trial days&#xD;
&#xD;
         14. Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
         15. Drug abuse&#xD;
&#xD;
         16. Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
         17. Excessive physical activities (within one week prior to administration or during the&#xD;
             treatment period)&#xD;
&#xD;
         18. Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
         19. A baseline prolongation of QT/QTc interval (e.g., a QTc interval ≥450 ms)&#xD;
&#xD;
         20. A history of additional risk factors for Torsades de points (TdP) (e.g., heart&#xD;
             failure, hypokalemia, family history of Long QT Syndrome)&#xD;
&#xD;
         21. Bradycardia (PR &lt;60 beats/min)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1277/1277.1_U11-3013-01.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 7, 2014</last_update_submitted>
  <last_update_submitted_qc>July 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 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/NCT02183662
org study id: 1277.1
nct id: NCT02183662
lead sponsor: 
To investigate safety and pharmacokinetics of BI 224436 ZW
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
measure: maximum measured concentration of the analyte in plasma
time frame: up to 72 hours
measure: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24
time frame: up to 24 hours
measure: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
time frame: up to 72 hours
measure: minimum observed concentration at 24 hours
time frame: up to 24 hours
measure: terminal half-life of the analyte in plasma
time frame: up to 72 hours
measure: time from dosing to maximum measured concentration of the analyte in plasma
time frame: up to 72 hours
measure: apparent clearance of the analyte in plasma
time frame: up to 72 hours
measure: apparent volume of distribution during the terminal phase λz
time frame: up to 72 hours
measure: apparent volume of distribution
time frame: up to 72 hours
measure: mean residence time of the analyte in the body after single oral administration
time frame: up to 72 hours
measure: terminal rate constant in plasma
time frame: up to 72 hours
measure: the last measurable concentration in the concentration-time profile
time frame: up to 72 hours
measure: the extrapolated Area under the curve from the time of the last measurable concentration in the concentration-time profile to infinity
time frame: up to 72 hours
measure: the percentage of the Area under the concentration-time curve until infinity, that is determined by extrapolation
time frame: up to 72 hours
measure: amount of analyte that is eliminated in urine from the time point t0 to time point t4
time frame: up to 4 hours
measure: amount of analyte that is eliminated in urine from the time point t4 to time point t8
time frame: from 4 to 8 hours
measure: amount of analyte that is eliminated in urine from the time point t8 to time point t12
time frame: from 8 to 12 hours
measure: amount of analyte that is eliminated in urine from the time point t12 to time point t24
time frame: from 12 to 24 hours
measure: fraction of analyte eliminated in urine from time point t0 to time point t24
time frame: up to 24 hours
measure: renal clearance of the analyte from the time point t0 until the time point t24
time frame: up to 24 hours
arm group label: BI 224436
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BI 224436
arm group label: BI 224436
intervention type: Drug
intervention name: Placebo to BI 224436
arm group label: Placebo
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1277/1277.1_U11-3013-01.pdf
description: Related Info
responsible party type: Sponsor