<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/NCT02259894</url>
  </required_header>
  <id_info>
    <org_study_id>1206.1</org_study_id>
    <nct_id>NCT02259894</nct_id>
  </id_info>
  <brief_title>Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX in Healthy Male Volunteers</brief_title>
  <official_title>Safety, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BIRT 2584 XX (5, 30, 100, 200, 350, 500, and 700 mg) as a Solution in PEG 400 Administered to Healthy Male Volunteers. Placebo Controlled and Blinded at Each Dose Level.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in&#xD;
      single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in&#xD;
      healthy subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2004</start_date>
  <primary_completion_date type="Actual">June 2004</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 participants with adverse events</measure>
    <time_frame>Up to 16 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with clinically significant changes in vital signs</measure>
    <time_frame>Up to 16 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal changes in clinical laboratory parameters</measure>
    <time_frame>Up to 16 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal findings in 12-lead ECG (electrocardiogram)</measure>
    <time_frame>Up to 16 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal findings in physical examination</measure>
    <time_frame>Screening and up to 16 days after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum concentration in plasma)</measure>
    <time_frame>Up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to maximum concentration)</measure>
    <time_frame>Up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time) interval from 0 extrapolated to infinity)</measure>
    <time_frame>Up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time) interval from 0 to the last quantifiable analyte plasma concentration)</measure>
    <time_frame>Up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>Up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>Up to 360 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 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent oral clearance in plasma after oral administration)</measure>
    <time_frame>Up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase λz) dose)</measure>
    <time_frame>Up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ae0-48 (amount of analyte that is eliminated in urine from 0-48 hours)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fe0-48 (fraction of analyte eliminated in urine from 0-48 hours)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLR,0-48 (renal clearance of the analyte from 0-48 hours)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receptor occupancy as determined by binding of anti-LFA-1 antibody fragment (Fab)</measure>
    <time_frame>Up to 360 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhibition of IL-2 production</measure>
    <time_frame>Up to 360 hours after drug administration</time_frame>
    <description>in response to superantigen challenge ex vivo</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIRT 2584</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single rising doses</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>BIRT 2584 XX</intervention_name>
    <arm_group_label>BIRT 2584</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;
          -  Signed written informed consent in accordance with Good Clinical Practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
          -  Age &gt;=18 and &lt;=50 years&#xD;
&#xD;
          -  BMI &gt;=18.5 and &lt;=29.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate, and&#xD;
             electrocardiogram) deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic,&#xD;
             haematological, oncological or hormonal disorders&#xD;
&#xD;
          -  Surgery of gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  Relevant 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 drugs with a long half-life (&gt; 24 hours) (&lt; 1 month prior to administration&#xD;
             or during the trial)&#xD;
&#xD;
          -  Use of any drugs, which might influence the results of the trial, (&lt; 10 days prior to&#xD;
             study drug administration or expected during the trial)&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (&lt; 2 months prior to&#xD;
             administration or expected during trial)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt;3 cigars or &gt;3 pipes/day)&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation or loss &gt; 400 mL, &lt; 1 month prior to administration or expected during&#xD;
             the trial&#xD;
&#xD;
          -  Clinically relevant laboratory abnormalities&#xD;
&#xD;
          -  Any ECG value outside of the reference range and of clinical relevance including, but&#xD;
             not limited to QRS interval &gt; 110 ms or QT interval, Bazett correction (QTcB) &gt; 450 ms&#xD;
             or QT interval &gt;500 ms&#xD;
&#xD;
          -  Inability to comply with dietary regimen of study centre&#xD;
&#xD;
          -  Inability to comply with investigator's instructions&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 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 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 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/NCT02259894
org study id: 1206.1
nct id: NCT02259894
lead sponsor: 
To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in
      single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in
      healthy subjects
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of participants with adverse events
time frame: Up to 16 days after drug administration
measure: Number of participants with clinically significant changes in vital signs
time frame: Up to 16 days after drug administration
measure: Number of participants with abnormal changes in clinical laboratory parameters
time frame: Up to 16 days after drug administration
measure: Number of participants with abnormal findings in 12-lead ECG (electrocardiogram)
time frame: Up to 16 days after drug administration
measure: Number of participants with abnormal findings in physical examination
time frame: Screening and up to 16 days after drug administration
measure: Cmax (maximum concentration in plasma)
time frame: Up to 360 hours after drug administration
measure: tmax (time from dosing to maximum concentration)
time frame: Up to 360 hours after drug administration
measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time) interval from 0 extrapolated to infinity)
time frame: Up to 360 hours after drug administration
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time) interval from 0 to the last quantifiable analyte plasma concentration)
time frame: Up to 360 hours after drug administration
measure: λz (terminal rate constant in plasma)
time frame: Up to 360 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: Up to 360 hours after drug administration
measure: MRT(mean residence time of the analyte in the body)
time frame: Up to 360 hours after drug administration
measure: CL/F (apparent oral clearance in plasma after oral administration)
time frame: Up to 360 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz) dose)
time frame: Up to 360 hours after drug administration
measure: Ae0-48 (amount of analyte that is eliminated in urine from 0-48 hours)
time frame: Up to 48 hours after drug administration
measure: fe0-48 (fraction of analyte eliminated in urine from 0-48 hours)
time frame: Up to 48 hours after drug administration
measure: CLR,0-48 (renal clearance of the analyte from 0-48 hours)
time frame: Up to 48 hours after drug administration
measure: Receptor occupancy as determined by binding of anti-LFA-1 antibody fragment (Fab)
time frame: Up to 360 hours after drug administration
measure: Inhibition of IL-2 production
time frame: Up to 360 hours after drug administration
description: in response to superantigen challenge ex vivo
arm group label: BIRT 2584
arm group type: Experimental
description: single rising doses
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIRT 2584 XX
arm group label: BIRT 2584
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor