<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/NCT02199873</url>
  </required_header>
  <id_info>
    <org_study_id>1150.1</org_study_id>
    <nct_id>NCT02199873</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacodynamics of BIIX 1 XX in Healthy Young Male Volunteers</brief_title>
  <official_title>A Single Increasing Dose Safety, Tolerability and Pharmacodynamics (Methacholine Challenge) Study After Inhalational Administration of BIIX 1 XX (Single Doses: 5 - 800 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)</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 the present study is to obtain information about the safety and tolerability&#xD;
      of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a&#xD;
      methacholine challenge test and to obtain preliminary pharmacokinetic data&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 1998</start_date>
  <primary_completion_date type="Actual">September 1998</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in impedance cardiography</measure>
    <time_frame>up to 30 minutes after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cutaneous microcirculation</measure>
    <time_frame>up to 30 minutes after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in airway resistance (Raw) after methacholine challenge</measure>
    <time_frame>up to 30 minutes after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in specific conductance (sGaw) after methacholine challenge</measure>
    <time_frame>up to 30 minutes after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC (Area under the concentration-time curve of the analyte in plasma)</measure>
    <time_frame>up to 168 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (Maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 168 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (Time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 168 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ae (Amount of analyte that is eliminated in urine)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRT (Mean residence time of the analyte in the body)</measure>
    <time_frame>up to 168 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ (Terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 168 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F(Apparent clearance of the analyte in plasma following extravascular administration)</measure>
    <time_frame>up to 168 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIIX 1 XX - single 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>BIIX 1 XX - single rising dose</intervention_name>
    <arm_group_label>BIIX 1 XX - single 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;
          -  Healthy male volunteers who have Broca-Indices within +-20%&#xD;
&#xD;
          -  Participants in the age range between 21 to 50 years&#xD;
&#xD;
          -  Following the methacholine challenge the airway resistance (Raw) shows an increase of&#xD;
             at least 130%&#xD;
&#xD;
          -  In accordance with Good Clinical Practice (GCP) and local legislation each volunteer&#xD;
             is supposed to give his written informed consent prior to admission to the study&#xD;
&#xD;
          -  As part of the screening (within 14 days before drug administration), each subject was&#xD;
             to receive a complete medical examination (including blood pressure, pulse rate,&#xD;
             medical history, documentation of demographics, inclusion/exclusion criteria and&#xD;
             concomitant therapy) as well as a 12-lead Electrocardiogram (ECG)&#xD;
&#xD;
          -  Haematopoietic, hepatic and renal function test will be carried out in the laboratory&#xD;
&#xD;
          -  The subjects will fast for 12 hours before collection of specimens for all laboratory&#xD;
             evaluations. The above mentioned examinations will be performed within 14 days before&#xD;
             the first administration of the test substance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers will be excluded from the study if the results of the medical examination&#xD;
             or laboratory tests are judged by the clinical investigator to differ significantly&#xD;
             from normal clinical values&#xD;
&#xD;
          -  Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular,&#xD;
             metabolic, immunological or hormonal disorders&#xD;
&#xD;
          -  Volunteers with diseases of the central nervous system (such as epilepsy) or with&#xD;
             psychiatric disorders&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             to the trial as judged by the investigator&#xD;
&#xD;
          -  Intake of a drug with a long half-life (&gt;= 24 hours) within one month before enrolment&#xD;
             in the study&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial the week previous to&#xD;
             the start of the study&#xD;
&#xD;
          -  Participation in another study with an investigational drug within the last two months&#xD;
             preceding this study&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or 3 cigars or 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on study days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation within the last 4 weeks&#xD;
&#xD;
          -  Excessive physical activities within the last week before the study&#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>October 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>October 28, 2014</last_update_submitted>
  <last_update_submitted_qc>October 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 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/NCT02199873
org study id: 1150.1
nct id: NCT02199873
lead sponsor: 
The objective of the present study is to obtain information about the safety and tolerability
      of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a
      methacholine challenge test and to obtain preliminary pharmacokinetic data
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double
measure: Number of subjects with adverse events
time frame: up to 3 months
measure: Number of subjects with abnormal changes in laboratory parameters
time frame: up to 8 days after last drug administration
measure: Change in impedance cardiography
time frame: up to 30 minutes after drug administration
measure: Change in cutaneous microcirculation
time frame: up to 30 minutes after drug administration
measure: Change in airway resistance (Raw) after methacholine challenge
time frame: up to 30 minutes after drug administration
measure: Change in specific conductance (sGaw) after methacholine challenge
time frame: up to 30 minutes after drug administration
measure: AUC (Area under the concentration-time curve of the analyte in plasma)
time frame: up to 168 hours after drug administration
measure: Cmax (Maximum measured concentration of the analyte in plasma)
time frame: up to 168 hours after drug administration
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 168 hours after drug administration
measure: Ae (Amount of analyte that is eliminated in urine)
time frame: up to 48 hours after drug administration
measure: MRT (Mean residence time of the analyte in the body)
time frame: up to 168 hours after drug administration
measure: t½ (Terminal half-life of the analyte in plasma)
time frame: up to 168 hours after drug administration
measure: CL/F(Apparent clearance of the analyte in plasma following extravascular administration)
time frame: up to 168 hours after drug administration
arm group label: BIIX 1 XX - single rising dose
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIIX 1 XX - single rising dose
arm group label: BIIX 1 XX - single rising dose
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