<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/NCT02209714</url>
  </required_header>
  <id_info>
    <org_study_id>1157.4</org_study_id>
    <nct_id>NCT02209714</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacodynamics After Oral Administration of BIIF 1149 BS in Healthy 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 (Single Doses as Tablets: 40, 65, 100 mg) in Healthy Male Volunteers (Randomised, Double-blind Within Each Dose Group, 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 study is to obtain information about the safety and tolerability of BIIF&#xD;
      1149 BS45 (single dose: 40, 65, 100 mg), to determine the pharmacologically active dose&#xD;
      (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic&#xD;
      data.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 1999</start_date>
  <primary_completion_date type="Actual">February 2000</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 clinically relevant changes in vital functions (blood pressure, pulse rate)</measure>
    <time_frame>up to 8 days after last 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 last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in laboratory parameters</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum drug plasma concentration (Cmax)</measure>
    <time_frame>up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach maximum drug concentration (tmax)</measure>
    <time_frame>up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total area under the plasma drug concentration-time curve (AUC) for several time points</measure>
    <time_frame>up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (t1/2)</measure>
    <time_frame>up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total clearance after oral administration (CLtot/f)</measure>
    <time_frame>up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of drug excreted in urine (Ae)</measure>
    <time_frame>up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of pharmacodynamic activity</measure>
    <time_frame>Screening, at least 15 days after first administration</time_frame>
    <description>Citric acid challenge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution during terminal phase after oral administration (Vz/F)</measure>
    <time_frame>up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance in the time interval form 0 to x h (Clren0-xh)</measure>
    <time_frame>up to 360 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>BIIF 1149 BS</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>BIIF 1149 BS</intervention_name>
    <arm_group_label>BIIF 1149 BS</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;
          -  +/- 20 % of their normal weight (Broca-Index)&#xD;
&#xD;
          -  Written informed consent&#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;
          -  Volunteers with known history of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Volunteers with chronic or relevant acute infections (especially respiratory&#xD;
             infections, cough)&#xD;
&#xD;
          -  Volunteers with history of allergy/hypersensitivity (including drug allergy) which is&#xD;
             deemed relevant to the trial as judged by the investigator&#xD;
&#xD;
          -  Volunteers who have taken a drug with a long half-life (≥ 24 hours) within ten&#xD;
             half-lives of the respective drug before enrolment in the study&#xD;
&#xD;
          -  Volunteers who received any other drugs which might influence the results of the study&#xD;
             during the week prior to the start of the study&#xD;
&#xD;
          -  Volunteers who have participated in another study with an investigational drug within&#xD;
             the last 2 months preceding this study&#xD;
&#xD;
          -  Volunteers who smoke more than 10 cigarettes (or equivalent) per day&#xD;
&#xD;
          -  Volunteers who are not able to refrain from smoking on study days&#xD;
&#xD;
          -  Volunteers who drink more than 40 g of alcohol per day&#xD;
&#xD;
          -  Volunteers who are dependent on drugs&#xD;
&#xD;
          -  Volunteers who are participated in excessive physical activities (e.g. competitive&#xD;
             sports) during the last week before the study&#xD;
&#xD;
          -  Volunteers who have donated blood (≥ 100 ml) within the last four weeks&#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 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 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/NCT02209714
org study id: 1157.4
nct id: NCT02209714
lead sponsor: 
The objective of the study is to obtain information about the safety and tolerability of BIIF
      1149 BS45 (single dose: 40, 65, 100 mg), 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 clinically relevant changes in vital functions (blood pressure, pulse rate)
time frame: up to 8 days after last drug administration
measure: Number of patients with clinically relevant changes in electrocardiogram (ECG)
time frame: up to 8 days after last drug administration
measure: Number of patients with clinically relevant changes in laboratory parameters
time frame: up to 8 days after last drug administration
measure: Number of patients with adverse events
time frame: up to 8 days after last drug administration
measure: Maximum drug plasma concentration (Cmax)
time frame: up to 360 hours after drug administration
measure: Time to reach maximum drug concentration (tmax)
time frame: up to 360 hours after drug administration
measure: Total area under the plasma drug concentration-time curve (AUC) for several time points
time frame: up to 360 hours after drug administration
measure: Terminal half-life (t1/2)
time frame: up to 360 hours after drug administration
measure: Mean residence time (MRT)
time frame: up to 360 hours after drug administration
measure: Total clearance after oral administration (CLtot/f)
time frame: up to 360 hours after drug administration
measure: Amount of drug excreted in urine (Ae)
time frame: up to 360 hours after drug administration
measure: Measurement of pharmacodynamic activity
time frame: Screening, at least 15 days after first administration
description: Citric acid challenge
measure: Volume of Distribution during terminal phase after oral administration (Vz/F)
time frame: up to 360 hours after drug administration
measure: Renal clearance in the time interval form 0 to x h (Clren0-xh)
time frame: up to 360 hours after drug administration
arm group label: BIIF 1149 BS
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIIF 1149 BS
arm group label: BIIF 1149 BS
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