<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/NCT02259985</url>
  </required_header>
  <id_info>
    <org_study_id>208.629</org_study_id>
    <nct_id>NCT02259985</nct_id>
  </id_info>
  <brief_title>Effects of Food on the Bioavailability and Pharmacokinetic Profile of Itasetron After a Single Oral Dose in Healthy Male Subjects</brief_title>
  <official_title>Investigation of the Effects of Food on the Bioavailability and Pharmacokinetic Profile of Itasetron After a Single Oral Dose of 1 mg in Healthy Male Subjects (3-way Cross-over)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      food interaction, pharmacokinetics, safety and tolerability&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 1998</start_date>
  <primary_completion_date type="Actual">May 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the concentration time curve from zero to infinity (AUC0-inf)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum concentration of drug in plasma</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to maximum concentration (tmax)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration time curve from zero to to the time of last data point above limit of quantitation (AUC0-tlast)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax/AUC ratio</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time in the body (MRTtot)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination half-life (t1/2)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution during the terminal phase λz (Vz)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total clearance from plasma (CLtot)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution after intravascular dose at steady state (Vss)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant findings in vital signs</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
    <description>blood pressure, pulse rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant findings in ECG</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant findings in laboratory tests</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Itasetron tablet fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Itasetron tablet fasted</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Itasetron infusion fasted</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itasetron tablet</intervention_name>
    <arm_group_label>Itasetron tablet fasted</arm_group_label>
    <arm_group_label>Itasetron tablet fed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itasetron infusion</intervention_name>
    <arm_group_label>Itasetron infusion fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>high fat breakfast</intervention_name>
    <arm_group_label>Itasetron tablet fed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all participants in the study will range from 21 to 50 years of age and be within +-&#xD;
             20% of their normal weight (Broca-index)&#xD;
&#xD;
          -  written informed consent in accordance with Good Clinical Practica and local&#xD;
             legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects will be excluded from the study if the results of the medical examination or&#xD;
             laboratory tests are judged by the investigator to differ significantly from normal&#xD;
             clinical values&#xD;
&#xD;
          -  Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular,&#xD;
             metabolic, immunological or hormonal disorders&#xD;
&#xD;
          -  Subjects with diseases of the central nervous system (such as epilepsy) or with&#xD;
             psychiatric disorders&#xD;
&#xD;
          -  Subjects with known history of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Subjects with chronic or relevant acute infections&#xD;
&#xD;
          -  Subjects with history of allergy/hypersensitivity (including drug allergy) which is&#xD;
             deemed relevant to the trial as judged by the investigator&#xD;
&#xD;
          -  Subjects who have taken a drug with a long half-life (&gt;= 24 hours) within one month&#xD;
             before enrolment in the study&#xD;
&#xD;
          -  Subjects who received any other drugs which might influence the results of the trial&#xD;
             during the week previous the start of the study&#xD;
&#xD;
          -  Subjects who have participated in another study with an investigational drug within&#xD;
             the last 2 months preceding this study&#xD;
&#xD;
          -  Subjects who are unable to refrain from smoking on study days&#xD;
&#xD;
          -  Subjects who smoke more than 10 cigarettes (or 3 cigars or pipes) per day&#xD;
&#xD;
          -  Subjects who drink more than 60 g of alcohol per day&#xD;
&#xD;
          -  Subjects who are dependent on drugs&#xD;
&#xD;
          -  Subjects who have donated blood (&gt;= 100 ml) within the last 4 weeks&#xD;
&#xD;
          -  Subjects who participated in excessive physical activities (e.g. competitive sports)&#xD;
             within the last week before 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>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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Itasetron</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/NCT02259985
org study id: 208.629
nct id: NCT02259985
lead sponsor: 
food interaction, pharmacokinetics, safety and tolerability
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration time curve from zero to infinity (AUC0-inf)
time frame: up to 48 hours after drug administration
measure: Maximum concentration of drug in plasma
time frame: up to 48 hours after drug administration
measure: Time to maximum concentration (tmax)
time frame: up to 48 hours after drug administration
measure: Area under the concentration time curve from zero to to the time of last data point above limit of quantitation (AUC0-tlast)
time frame: up to 48 hours after drug administration
measure: Cmax/AUC ratio
time frame: up to 48 hours after drug administration
measure: Mean residence time in the body (MRTtot)
time frame: up to 48 hours after drug administration
measure: Elimination half-life (t1/2)
time frame: up to 48 hours after drug administration
measure: Apparent volume of distribution during the terminal phase λz (Vz)
time frame: up to 48 hours after drug administration
measure: Total clearance from plasma (CLtot)
time frame: up to 48 hours after drug administration
measure: Apparent volume of distribution after intravascular dose at steady state (Vss)
time frame: up to 48 hours after drug administration
measure: Number of participants with clinically significant findings in vital signs
time frame: up to 8 days after last drug administration
description: blood pressure, pulse rate
measure: Number of participants with clinically significant findings in ECG
time frame: up to 8 days after last drug administration
measure: Number of participants with clinically significant findings in laboratory tests
time frame: up to 8 days after last drug administration
measure: Number of participants with adverse events
time frame: up to 8 days after last drug administration
arm group label: Itasetron tablet fed
arm group type: Experimental
arm group label: Itasetron tablet fasted
arm group type: Active Comparator
arm group label: Itasetron infusion fasted
arm group type: Active Comparator
intervention type: Drug
intervention name: Itasetron tablet
arm group label: Itasetron tablet fasted
arm group label: Itasetron tablet fed
intervention type: Drug
intervention name: Itasetron infusion
arm group label: Itasetron infusion fasted
intervention type: Other
intervention name: high fat breakfast
arm group label: Itasetron tablet fed
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
mesh term: Itasetron