<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/NCT02199899</url>
  </required_header>
  <id_info>
    <org_study_id>1157.2</org_study_id>
    <nct_id>NCT02199899</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacodynamics of BIIF 1149 BS in Healthy Young Male Volunteers</brief_title>
  <official_title>A Single Increasing Dose Safety, Tolerability and Pharmacodynamics (Citric Acid Challenge) Study After Oral Administration of BIIF 1149 BS (Drinking Solution, Single Doses: 0.1 - 25 mg; in Addition, at 25 mg Also as a 25 mg Tablet) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled, Parallel 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>
      The objective of the present study is to obtain information about the safety and tolerability&#xD;
      of BIIF 1149 BS, to determine the pharmacologically active dose (range) by performing a&#xD;
      citric acid challenge test and to obtain preliminary pharmacokinetic data&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 1999</start_date>
  <primary_completion_date type="Actual">July 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 4 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC (Area under the concentration-time curve of the analyte in plasma)</measure>
    <time_frame>up to 120 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 120 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 120 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ae (Amount of parent drug excreted into urine)</measure>
    <time_frame>up to 120 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 120 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 120 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 120 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ae (amount of analyte excreted into Urine)</measure>
    <time_frame>up to 120 h after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLren (renal clearance)</measure>
    <time_frame>up to 120 h after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIIF 1149 BS - single rising doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BIIF 1149 BS oral drinking solution and a BIIF 1149 BS tablet</description>
  </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>BIIF 1149 BS - single rising doses</intervention_name>
    <arm_group_label>BIIF 1149 BS - single 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;
          -  Participants should be healthy males&#xD;
&#xD;
          -  Age range from 21 to 50 years&#xD;
&#xD;
          -  Within +- 20% of their normal weight (Broca-Index)&#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;
          -  Each subject will have his medical history taken and will receive a complete medical&#xD;
             examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead&#xD;
             Electrocardiogram (ECG)&#xD;
&#xD;
          -  A citric acid provocation test will be performed to determine the cumulative dose of&#xD;
             citric acid which causes at least three coughs. If there will not be at least three&#xD;
             coughs after inhalation up to the highest citric acid concentration of 32 % the&#xD;
             volunteer will be replaced by a new person&#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 (especially respiratory infections, cough)&#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 ten half-lives of the&#xD;
             respective drug before enrolment in the study&#xD;
&#xD;
          -  Use of any other drugs which might influence the results of the trial during the week&#xD;
             previous to 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; 40g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (&gt;= 100 ml) within the last 4 weeks&#xD;
&#xD;
          -  Excessive physical activities (e.g. competitive sports) within the last week before&#xD;
             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>July 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>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 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/NCT02199899
org study id: 1157.2
nct id: NCT02199899
lead sponsor: 
The objective of the present study is to obtain information about the safety and tolerability
      of BIIF 1149 BS, to determine the pharmacologically active dose (range) by performing a
      citric acid challenge test and to obtain preliminary pharmacokinetic data
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of patients with adverse events
time frame: up to 4 months
measure: AUC (Area under the concentration-time curve of the analyte in plasma)
time frame: up to 120 hours after drug administration
measure: Cmax (Maximum measured concentration of the analyte in plasma)
time frame: up to 120 hours after drug administration
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 120 hours after drug administration
measure: Ae (Amount of parent drug excreted into urine)
time frame: up to 120 hours after drug administration
measure: MRT (Mean residence time of the analyte in the body)
time frame: up to 120 hours after drug administration
measure: t½ (Terminal half-life of the analyte in plasma)
time frame: up to 120 hours after drug administration
measure: CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
time frame: up to 120 hours after drug administration
measure: Ae (amount of analyte excreted into Urine)
time frame: up to 120 h after drug administration
measure: CLren (renal clearance)
time frame: up to 120 h after drug administration
arm group label: BIIF 1149 BS - single rising doses
arm group type: Experimental
description: BIIF 1149 BS oral drinking solution and a BIIF 1149 BS tablet
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIIF 1149 BS - single rising doses
arm group label: BIIF 1149 BS - single 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