<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/NCT02203487</url>
  </required_header>
  <id_info>
    <org_study_id>1157.3</org_study_id>
    <nct_id>NCT02203487</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of Increasing Repeated Doses of BIIF 1149 BS in Healthy Male Volunteers</brief_title>
  <official_title>A Double-blind (Within Dose Groups), Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability and Preliminary Pharmacokinetics of Increasing Repeated Oral Doses (Nine Days Treatment of 5 mg and 10 mg and Eighteen Days Treatment of 25 mg and 40 mg) of BIIF 1149 BS in Healthy Male Volunteers</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 was to obtain information about the safety and&#xD;
      tolerability of BIIF 1149 BS after repeated dosing and to obtain preliminary pharmacokinetics&#xD;
      data (steady state and accumulation factor)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 1999</start_date>
  <primary_completion_date type="Actual">June 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 subjects with adverse events</measure>
    <time_frame>up to 55 days</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 blood sample</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)</measure>
    <time_frame>up to 8 days after last blood sample</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant changes in 12-lead Electrocardiogram (ECG)</measure>
    <time_frame>up to 8 days after last blood sample</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (Maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 360 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax (Time to maximum observed concentration of the analyte in plasma)</measure>
    <time_frame>up to 360 hours after last 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 360 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ae (Urinary excretion of parent drug)</measure>
    <time_frame>up to 120 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin,ss (Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)</measure>
    <time_frame>after 24 hours of drug administration on day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRT (Mean residence time of the analyte in the body)</measure>
    <time_frame>up to 360 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ (Terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 360 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent peak-trough fluctuation</measure>
    <time_frame>up to 360 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RA (AUC) Accumulation factor based on AUC-data</measure>
    <time_frame>up to 360 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RA (Ae) Accumulation factor based on Ae-data</measure>
    <time_frame>up to 120 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RA (Cmax) Accumulation factor based on Cmax -data</measure>
    <time_frame>up to 360 hours after drug administration on day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cav (Average plasma concentration in a steady state interval)</measure>
    <time_frame>24 hours after drug administration of day 9</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIIF 1149 BS - 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>BIIF 1149 BS - single rising dose</intervention_name>
    <arm_group_label>BIIF 1149 BS - 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;
          -  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 volunteers&#xD;
             are supposed to give their 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. demographics, medical history, check of inclusion/exclusion&#xD;
             criteria, physical examination, vital signs, 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 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 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 29, 2014</last_update_submitted>
  <last_update_submitted_qc>July 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 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/NCT02203487
org study id: 1157.3
nct id: NCT02203487
lead sponsor: 
The objective of the present study was to obtain information about the safety and
      tolerability of BIIF 1149 BS after repeated dosing and to obtain preliminary pharmacokinetics
      data (steady state and accumulation factor)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of subjects with adverse events
time frame: up to 55 days
measure: Number of subjects with abnormal changes in laboratory parameters
time frame: up to 8 days after last blood sample
measure: Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
time frame: up to 8 days after last blood sample
measure: Number of subjects with clinically significant changes in 12-lead Electrocardiogram (ECG)
time frame: up to 8 days after last blood sample
measure: Cmax (Maximum concentration of the analyte in plasma)
time frame: up to 360 hours after last drug administration
measure: Tmax (Time to maximum observed concentration of the analyte in plasma)
time frame: up to 360 hours after last drug administration
measure: AUC (Area under the concentration-time curve of the analyte in plasma)
time frame: up to 360 hours after last drug administration
measure: Ae (Urinary excretion of parent drug)
time frame: up to 120 hours after last drug administration
measure: Cmin,ss (Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
time frame: after 24 hours of drug administration on day 9
measure: MRT (Mean residence time of the analyte in the body)
time frame: up to 360 hours after last drug administration
measure: t½ (Terminal half-life of the analyte in plasma)
time frame: up to 360 hours after last drug administration
measure: Percent peak-trough fluctuation
time frame: up to 360 hours after last drug administration
measure: RA (AUC) Accumulation factor based on AUC-data
time frame: up to 360 hours after last drug administration
measure: RA (Ae) Accumulation factor based on Ae-data
time frame: up to 120 hours after last drug administration
measure: RA (Cmax) Accumulation factor based on Cmax -data
time frame: up to 360 hours after drug administration on day 9
measure: Cav (Average plasma concentration in a steady state interval)
time frame: 24 hours after drug administration of day 9
arm group label: BIIF 1149 BS - single rising dose
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIIF 1149 BS - single rising dose
arm group label: BIIF 1149 BS - 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