<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/NCT02209831</url>
  </required_header>
  <id_info>
    <org_study_id>1175.17</org_study_id>
    <nct_id>NCT02209831</nct_id>
  </id_info>
  <brief_title>Bioavailability of Oral BIRB 796 BS Tablets With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers</brief_title>
  <official_title>An Open Label, Randomised, Crossover Study of the Bioavailability of Oral BIRB 796 BS Tablets (30 mg Single Dose) With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers to Assess the Effect of Gastric pH on Absorption of BIRB 796 BS.</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 assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS.&#xD;
&#xD;
      Safety and tolerability were also assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2001</start_date>
  <primary_completion_date type="Actual">January 2002</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve from time 0 mathematically extrapolated to time infinity (AUC0-inf.)</measure>
    <time_frame>up to 36 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum observed plasma concentration (Cmax)</measure>
    <time_frame>up to 36 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve over a given time interval (AUC0-t)</measure>
    <time_frame>up to 36 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to the maximum plasma concentration (tmax)</measure>
    <time_frame>up to 36 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent oral clearance (CL/F)</measure>
    <time_frame>up to 36 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)</measure>
    <time_frame>up to 36 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination half-life (t1/2)</measure>
    <time_frame>up to 36 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>up to 36 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastric pH measurements</measure>
    <time_frame>up to 12 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 34 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability</measure>
    <time_frame>on the last 1 day of second treatment</time_frame>
    <description>based on the ability of the subjects to take the medicine as well as occurence of adverse events and abnormal laboratory investigations</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIBR 796 BS + pantoprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBR 796 BS without pantoprazole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BIBR 796 BS</intervention_name>
    <description>single dose</description>
    <arm_group_label>BIBR 796 BS + pantoprazole</arm_group_label>
    <arm_group_label>BIBR 796 BS without pantoprazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pantoprazole</intervention_name>
    <description>5 days</description>
    <arm_group_label>BIBR 796 BS + pantoprazole</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;=55 years&#xD;
&#xD;
          -  Laboratory examinations within a clinically defined reference range&#xD;
&#xD;
          -  Helicobacter pylori negative&#xD;
&#xD;
          -  Able to tolerate pH probe application&#xD;
&#xD;
          -  Body mass index (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;
             hormonal disorders&#xD;
&#xD;
          -  Surgery of gastrointestinal tract (excluding appendectomy)&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#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 including study drugs&#xD;
&#xD;
          -  History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within 1 month or 10 half lives of&#xD;
             that drug, whichever is longer, prior to administration of study drugs or during the&#xD;
             trial&#xD;
&#xD;
          -  Use of any drugs that might influence the results of the trial within 10 days prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Use of grapefruit or grapefruit juice, alcohol, green tea, methylxanthine-containing&#xD;
             products or tobacco within 5 days of study drug administration&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within 1 month prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood or plasma donation (&gt;400 ml) within 1 month prior to administration or during&#xD;
             trial&#xD;
&#xD;
          -  Excessive physical activities within 5 days prior to administration or during the&#xD;
             trial&#xD;
&#xD;
          -  Following specific laboratory findings: aspartate aminotransferase, alanine&#xD;
             transaminase, Gamma-glutamyl-transferase above the reference range&#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>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://clintriage.rdg@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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pantoprazole</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02209831
org study id: 1175.17
nct id: NCT02209831
lead sponsor: 
Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS.

      Safety and tolerability were also assessed.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the plasma concentration versus time curve from time 0 mathematically extrapolated to time infinity (AUC0-inf.)
time frame: up to 36 hours after drug administration
measure: Maximum observed plasma concentration (Cmax)
time frame: up to 36 hours after drug administration
measure: Area under the plasma concentration versus time curve over a given time interval (AUC0-t)
time frame: up to 36 hours after drug administration
measure: Time to the maximum plasma concentration (tmax)
time frame: up to 36 hours after drug administration
measure: Apparent oral clearance (CL/F)
time frame: up to 36 hours after drug administration
measure: Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
time frame: up to 36 hours after drug administration
measure: Elimination half-life (t1/2)
time frame: up to 36 hours after drug administration
measure: Mean residence time (MRT)
time frame: up to 36 hours after drug administration
measure: Gastric pH measurements
time frame: up to 12 hours after drug administration
measure: Number of patients with adverse events
time frame: up to 34 days
measure: Assessment of tolerability
time frame: on the last 1 day of second treatment
description: based on the ability of the subjects to take the medicine as well as occurence of adverse events and abnormal laboratory investigations
arm group label: BIBR 796 BS + pantoprazole
arm group type: Experimental
arm group label: BIBR 796 BS without pantoprazole
arm group type: Active Comparator
intervention type: Device
intervention name: BIBR 796 BS
description: single dose
arm group label: BIBR 796 BS + pantoprazole
arm group label: BIBR 796 BS without pantoprazole
intervention type: Drug
intervention name: Pantoprazole
description: 5 days
arm group label: BIBR 796 BS + pantoprazole
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://clintriage.rdg@boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Pantoprazole