<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/NCT02265302</url>
  </required_header>
  <id_info>
    <org_study_id>543.1</org_study_id>
    <nct_id>NCT02265302</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males</brief_title>
  <official_title>A Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Single Oral Doses of BIIL 284 BS (Dose Range: 0.025 mg - 75 mg PSE Solution, 25 mg, 75 mg, 250 mg and 750 mg WIF Tablets) in Healthy Male Volunteers as Well as Food Effects at 75 mg (WIF Tablet)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the&#xD;
      pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by&#xD;
      determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary&#xD;
      pharmacokinetic data as well as first information on food effects after administration of the&#xD;
      75 mg WIF tablet in healthy male volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 1998</start_date>
  <primary_completion_date type="Actual">December 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with clinically relevant changes in vital signs</measure>
    <time_frame>up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically relevant changes in electrocardiogram</measure>
    <time_frame>up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically relevant changes in laboratory parameters</measure>
    <time_frame>up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in white blood cell count</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
    <description>determined by flow cytometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in differential blood cell count</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
    <description>determined by flow cytometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach maximum plasma concentration (tmax)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC) for several time intervals</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (t1/2)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total mean residence time (MRTtot)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total clearance after oral administration (CLtot/f)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution during terminal phase after oral administration (Vz/f)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIIL 284 BS oral solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIIL 284 BS WIF tablets</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>BIIL 284 oral solution</intervention_name>
    <arm_group_label>BIIL 284 BS oral solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIIL 284 wetability improved formulation (WIF) tablets</intervention_name>
    <arm_group_label>BIIL 284 BS WIF tablets</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 subjects as determined by results of screening&#xD;
&#xD;
          -  Age ≥ 21 and ≤ 50 years&#xD;
&#xD;
          -  Broca ≥ - 20% and ≤ + 20%&#xD;
&#xD;
          -  Signed written informed consent in accordance with Good Clinical Practice and local&#xD;
             legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Results of the medical examination or laboratory tests that are judged by the clinical&#xD;
             investigator to differ significantly from normal clinical values&#xD;
&#xD;
          -  Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or with psychiatric&#xD;
             disorders&#xD;
&#xD;
          -  Known 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 ten half-lives of the respective drug before enrolment in the study&#xD;
&#xD;
          -  Intake of any other drugs which might influence the results of the trial during the&#xD;
             week 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;
          -  Smokers (&gt; 5 cigarettes or 2 cigars or 2 pipes/day)&#xD;
&#xD;
          -  Volunteer who is not able to refrain from smoking on study days&#xD;
&#xD;
          -  Alcohol abuse (more than 60 g of alcohol per day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Excessive physical activities (e.g. competitive sports) within the last week before&#xD;
             the study&#xD;
&#xD;
          -  Blood donation within the last 4 weeks (≥ 100 ml)&#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>October 14, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 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/NCT02265302
org study id: 543.1
nct id: NCT02265302
lead sponsor: 
Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the
      pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by
      determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary
      pharmacokinetic data as well as first information on food effects after administration of the
      75 mg WIF tablet in healthy male volunteers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of subjects with clinically relevant changes in vital signs
time frame: up to 8 days after drug administration
measure: Number of subjects with clinically relevant changes in electrocardiogram
time frame: up to 8 days after drug administration
measure: Number of subjects with clinically relevant changes in laboratory parameters
time frame: up to 8 days after drug administration
measure: Number of subjects with adverse events
time frame: up to 8 days after drug administration
measure: Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1)
time frame: up to 72 hours after drug administration
measure: Changes in white blood cell count
time frame: up to 48 hours after drug administration
description: determined by flow cytometer
measure: Changes in differential blood cell count
time frame: up to 48 hours after drug administration
description: determined by flow cytometer
measure: Maximum plasma concentration (Cmax)
time frame: up to 72 hours after drug administration
measure: Time to reach maximum plasma concentration (tmax)
time frame: up to 72 hours after drug administration
measure: Area under the plasma concentration-time curve (AUC) for several time intervals
time frame: up to 72 hours after drug administration
measure: Terminal half-life (t1/2)
time frame: up to 72 hours after drug administration
measure: Total mean residence time (MRTtot)
time frame: up to 72 hours after drug administration
measure: Total clearance after oral administration (CLtot/f)
time frame: up to 72 hours after drug administration
measure: Volume of distribution during terminal phase after oral administration (Vz/f)
time frame: up to 72 hours after drug administration
arm group label: BIIL 284 BS oral solution
arm group type: Experimental
arm group label: BIIL 284 BS WIF tablets
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIIL 284 oral solution
arm group label: BIIL 284 BS oral solution
intervention type: Drug
intervention name: BIIL 284 wetability improved formulation (WIF) tablets
arm group label: BIIL 284 BS WIF tablets
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