<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/NCT02198287</url>
  </required_header>
  <id_info>
    <org_study_id>1150.7</org_study_id>
    <nct_id>NCT02198287</nct_id>
  </id_info>
  <brief_title>Dose Extension Study of BIIX 1 XX in Healthy Young Male Volunteers</brief_title>
  <official_title>A Single Increasing Dose Safety and Tolerability Study (Dose Extension) After Inhalational Administration of BIIX 1 XX (Single Doses: 800 - 2000 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>
      Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 1999</start_date>
  <primary_completion_date type="Actual">April 1999</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 patients with adverse events</measure>
    <time_frame>up to 22 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in vital parameters (Blood pressure, Pulse rate)</measure>
    <time_frame>up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in electrocardiogram (ECG)</measure>
    <time_frame>up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in impedance cardiography</measure>
    <time_frame>pre-dose, 10 and 30 minutes after administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in cutaneous microcirculation</measure>
    <time_frame>pre-dose, 10 and 30 minutes after administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in safety laboratory parameters</measure>
    <time_frame>up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration of the drug in plasma (Cmax)</measure>
    <time_frame>up to 168 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma drug concentration-time curve from zero time to the last time point of measurement (AUC0-tz)</measure>
    <time_frame>up to 168 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of the analyte in plasma (t1/2)</measure>
    <time_frame>up to 168 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance, divided by f (CL/f)</measure>
    <time_frame>up to 168 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIIX 1 XX, rising doses</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 inhalation solution</intervention_name>
    <description>single doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg</description>
    <arm_group_label>BIIX 1 XX, rising doses</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, based on a complete medical examination&#xD;
&#xD;
          -  Age range from 21 to 50 years&#xD;
&#xD;
          -  Participant must be within +/- 20 % of their normal weight (Broca-Index)&#xD;
&#xD;
          -  Participant must provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and&#xD;
             electrocardiogram) or laboratory tests deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or 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 (≥ 24 hours) within at least one month or less&#xD;
             than then half-lives of the respective drug before enrolment in the study&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial within seven days&#xD;
             prior to administration or during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within two months prior to&#xD;
             start of the 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&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (&gt; 100 ml) within four weeks prior to administration&#xD;
&#xD;
          -  Other disease or abnormality of clinical relevance&#xD;
&#xD;
          -  Excessive physical activities within two weeks prior to administration or during the&#xD;
             trial&#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>July 2014</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 22, 2014</last_update_submitted>
  <last_update_submitted_qc>July 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 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/NCT02198287
org study id: 1150.7
nct id: NCT02198287
lead sponsor: 
Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of patients with adverse events
time frame: up to 22 days
measure: Number of patients with clinically relevant changes in vital parameters (Blood pressure, Pulse rate)
time frame: up to 8 days after drug administration
measure: Number of patients with clinically relevant changes in electrocardiogram (ECG)
time frame: up to 8 days after drug administration
measure: Number of patients with clinically relevant changes in impedance cardiography
time frame: pre-dose, 10 and 30 minutes after administration
measure: Number of patients with clinically relevant changes in cutaneous microcirculation
time frame: pre-dose, 10 and 30 minutes after administration
measure: Number of patients with clinically relevant changes in safety laboratory parameters
time frame: up to 8 days after drug administration
measure: Maximum concentration of the drug in plasma (Cmax)
time frame: up to 168 hours after drug administration
measure: Area under the plasma drug concentration-time curve from zero time to the last time point of measurement (AUC0-tz)
time frame: up to 168 hours after drug administration
measure: Terminal half-life of the analyte in plasma (t1/2)
time frame: up to 168 hours after drug administration
measure: Clearance, divided by f (CL/f)
time frame: up to 168 hours after drug administration
arm group label: BIIX 1 XX, rising doses
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIIX 1 XX inhalation solution
description: single doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg
arm group label: BIIX 1 XX, rising doses
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