<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/NCT02215031</url>
  </required_header>
  <id_info>
    <org_study_id>1246.12</org_study_id>
    <nct_id>NCT02215031</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Doses of BI 44370 BS Solution in Healthy Male Volunteers</brief_title>
  <official_title>Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Doses (10 to 50 mg) of BI 44370 BS Solution in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Phase I)</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 investigate safety, tolerability, and pharmacokinetics of BI 44370 BS solution for&#xD;
      intravenous (i.v.) infusion&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <primary_completion_date type="Actual">November 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>Single</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with clinically significant findings in vital signs</measure>
    <time_frame>up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant findings in 12-lead electrocardiogram (ECG)</measure>
    <time_frame>up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant laboratory findings</measure>
    <time_frame>up to 16 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 37 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of global tolerability by investigator on a 4-point scale</measure>
    <time_frame>within 14 days after last trial procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to maximum measured concentration)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞ (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 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)</measure>
    <time_frame>up to 24 hours after drug administration</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 time of the last quantifiable data point)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-2 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 2 hours after drug application)</measure>
    <time_frame>up to 2 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from time point t1 to time point t2)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTinf (mean residence time of the analyte in the body after intravenous administration)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL (total clearance of the analyte in plasma after intravascular administration)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz (apparent volume of distribution during the terminal phase λz following an intravascular dose)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vss (apparent volume of distribution at steady state following intravascular administration)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)</measure>
    <time_frame>up to 24 hours after drug administration</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 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 44370</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 44370</intervention_name>
    <arm_group_label>BI 44370</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;
          -  Healthy males according to the following criteria based upon a complete medical&#xD;
             history, including the physical examination, vital signs (Blood Pressure (BP), Pulse&#xD;
             Rate (PR), Respiratory Rate (RR) and body temperature), 12-lead ECG, clinical&#xD;
             laboratory tests&#xD;
&#xD;
          -  Age 21 to 50 years inclusive&#xD;
&#xD;
          -  Body Mass Index (BMI) 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 Good Clinical Practice and German law&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including BP, PR, RR, body temperature and&#xD;
             ECG) deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Any evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Surgery of the gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological 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/hypersensitivity (including allergy to drug or its&#xD;
             excipients)&#xD;
&#xD;
          -  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;
          -  Use of drugs which might reasonably influence the results of the trial or that prolong&#xD;
             the QT/QTc interval based on the knowledge at the time of protocol preparation within&#xD;
             10 days prior to administration or during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
          -  Excessive physical activities (within one week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
          -  Inability to comply with dietary regimen of trial site&#xD;
&#xD;
          -  A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a&#xD;
             QTc interval &gt;450 ms)&#xD;
&#xD;
          -  A history of additional risk factors for torsade de pointes (e.g., heart failure,&#xD;
             hypokalemia, family history of Long QT Syndrome)&#xD;
&#xD;
          -  Not willing to use adequate contraception (condom use plus another form of&#xD;
             contraception, e.g. spermicide, oral contraceptive taken by female partner,&#xD;
             sterilisation, or intrauterine device) during the whole study period from the time of&#xD;
             the first intake of study drug until three months after the last intake&#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</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 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/NCT02215031
org study id: 1246.12
nct id: NCT02215031
lead sponsor: 
Study to investigate safety, tolerability, and pharmacokinetics of BI 44370 BS solution for
      intravenous (i.v.) infusion
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single
measure: Number of patients with clinically significant findings in vital signs
time frame: up to 16 days
measure: Number of patients with clinically significant findings in 12-lead electrocardiogram (ECG)
time frame: up to 16 days
measure: Number of patients with clinically significant laboratory findings
time frame: up to 16 days
measure: Number of patients with adverse events
time frame: up to 37 days
measure: Assessment of global tolerability by investigator on a 4-point scale
time frame: within 14 days after last trial procedure
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 24 hours after drug administration
measure: tmax (time from dosing to maximum measured concentration)
time frame: up to 24 hours after drug administration
measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 24 hours after drug administration
measure: %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
time frame: up to 24 hours after drug administration
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
time frame: up to 24 hours after drug administration
measure: AUC0-2 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 2 hours after drug application)
time frame: up to 2 hours after drug administration
measure: AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from time point t1 to time point t2)
time frame: up to 24 hours after drug administration
measure: λz (terminal rate constant in plasma)
time frame: up to 24 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: up to 24 hours after drug administration
measure: MRTinf (mean residence time of the analyte in the body after intravenous administration)
time frame: up to 24 hours after drug administration
measure: CL (total clearance of the analyte in plasma after intravascular administration)
time frame: up to 24 hours after drug administration
measure: Vz (apparent volume of distribution during the terminal phase λz following an intravascular dose)
time frame: up to 24 hours after drug administration
measure: Vss (apparent volume of distribution at steady state following intravascular administration)
time frame: up to 24 hours after drug administration
measure: Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
time frame: up to 24 hours after drug administration
measure: fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
time frame: up to 24 hours after drug administration
measure: CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
time frame: up to 24 hours after drug administration
arm group label: BI 44370
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BI 44370
arm group label: BI 44370
intervention type: Drug
intervention name: Placebo
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
description: Related Info
responsible party type: Sponsor