<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/NCT02208856</url>
  </required_header>
  <id_info>
    <org_study_id>1175.1</org_study_id>
    <nct_id>NCT02208856</nct_id>
  </id_info>
  <brief_title>Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses Oral BIRB 796 BS in Healthy Human Subjects</brief_title>
  <official_title>Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses (1, 4, 15, 50, 100, 200, 400, and 600 mg) Oral BIRB 796 BS in Healthy Human Subjects. A Placebo Controlled, Randomised Study, Double 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, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single&#xD;
      doses, with and without a 64 g fat breakfast at one selected dose.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 1999</start_date>
  <primary_completion_date type="Actual">December 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 subjects with clinically relevant changes in vital signs</measure>
    <time_frame>Baseline, up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically relevant changes in laboratory measurements</measure>
    <time_frame>Baseline, up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically relevant changes in electrocardiograms (ECG)</measure>
    <time_frame>Baseline, up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration of the analyte in plasma (Cmax)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC0-inf)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to the maximum concentration of the analyte in plasma (Tmax)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant of the analyte in plasma (λz)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half life of the analyte in plasma (t1/2)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of the analyte in the body (MRTtot)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance of the analyte in plasma (CL/F)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution during the terminal phase λz (Vz/F)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mac-1/L selectin ratio of formyl-methionyl-leucyl-phenylalanine (fMLP)-stimulated to unstimulated neutrophils</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mac-1/L selectin ratio of TNFalpha-stimulated to unstimulated neutrophils</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent changes in TNFalpha production</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
    <description>after ex vivo stimulation of whole blood with endotoxin</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBR 796 BS food effect</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBR 796 BS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBR 796 BS</intervention_name>
    <arm_group_label>BIBR 796 BS</arm_group_label>
    <arm_group_label>BIBR 796 BS food effect</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>high fat standardized breakfast</intervention_name>
    <arm_group_label>BIBR 796 BS food effect</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;= 45 years&#xD;
&#xD;
          -  Broca &gt;= -20% and &lt;= +20%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological 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;
          -  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;
             ot the trial as judged by the investigator&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) (= 1 month prior to administration&#xD;
             or during the trial)&#xD;
&#xD;
          -  Use of any drugs, which might influence the results of the trial (= 10 days prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (=2 months prior to&#xD;
             administration or during trial)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes of &gt; 3 cigars of &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation &gt; 400 ml (=1 month prior to administration of during the trial)&#xD;
&#xD;
          -  Excessive physical activities (= 5 days prior to administration or during the trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range of clinical relevance (but not&#xD;
             exclusive to) total white cell count &gt;= 10 x 10**9/L, C-reactive protein &gt;= 4.5 mg/L,&#xD;
             any haemoglobin or &gt; 15 mg/dl protein on urine dipstick&#xD;
&#xD;
          -  History of any familial bleeding disorder&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 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 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 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/NCT02208856
org study id: 1175.1
nct id: NCT02208856
lead sponsor: 
To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single
      doses, with and without a 64 g fat breakfast at one selected dose.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of subjects with clinically relevant changes in vital signs
time frame: Baseline, up to 96 hours after drug administration
measure: Number of subjects with clinically relevant changes in laboratory measurements
time frame: Baseline, up to 96 hours after drug administration
measure: Number of subjects with clinically relevant changes in electrocardiograms (ECG)
time frame: Baseline, up to 96 hours after drug administration
measure: Number of subjects with adverse events
time frame: up to 96 hours after drug administration
measure: Maximum concentration of the analyte in plasma (Cmax)
time frame: up to 48 hours after drug administration
measure: Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC0-inf)
time frame: up to 48 hours after drug administration
measure: Time from dosing to the maximum concentration of the analyte in plasma (Tmax)
time frame: up to 48 hours after drug administration
measure: Terminal rate constant of the analyte in plasma (λz)
time frame: up to 48 hours after drug administration
measure: Half life of the analyte in plasma (t1/2)
time frame: up to 48 hours after drug administration
measure: Mean residence time of the analyte in the body (MRTtot)
time frame: up to 48 hours after drug administration
measure: Apparent clearance of the analyte in plasma (CL/F)
time frame: up to 96 hours after drug administration
measure: Apparent volume of distribution during the terminal phase λz (Vz/F)
time frame: up to 48 hours after drug administration
measure: Mac-1/L selectin ratio of formyl-methionyl-leucyl-phenylalanine (fMLP)-stimulated to unstimulated neutrophils
time frame: up to 48 hours after drug administration
measure: Mac-1/L selectin ratio of TNFalpha-stimulated to unstimulated neutrophils
time frame: up to 48 hours after drug administration
measure: Percent changes in TNFalpha production
time frame: up to 48 hours after drug administration
description: after ex vivo stimulation of whole blood with endotoxin
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: BIBR 796 BS food effect
arm group type: Experimental
arm group label: BIBR 796 BS
arm group type: Experimental
intervention type: Drug
intervention name: BIBR 796 BS
arm group label: BIBR 796 BS
arm group label: BIBR 796 BS food effect
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Other
intervention name: high fat standardized breakfast
arm group label: BIBR 796 BS food effect
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor