<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/NCT02260037</url>
  </required_header>
  <id_info>
    <org_study_id>262.261</org_study_id>
    <nct_id>NCT02260037</nct_id>
  </id_info>
  <brief_title>Dose Tolerance Study in Healthy Male Volunteers After Intranasal Application of Epinastine Nasal</brief_title>
  <official_title>A Double-blind, Randomised, Placebo-controlled Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intranasal Application of Epinastine Nasal (Dosage: 0.035 mg (0.025 % Solution) - 0.42 mg (0.3 % Solution))</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Safety, tolerability and pharmacokinetics&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2001</start_date>
  <primary_completion_date type="Actual">September 2001</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with clinically relevant findings in vital signs</measure>
    <time_frame>up to 8 days after drug administration</time_frame>
    <description>blood pressure, pulse rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant findings in 12-lead ECG</measure>
    <time_frame>up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant findings in laboratory parameters</measure>
    <time_frame>up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in rhinoscopy assessment</measure>
    <time_frame>up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum measured concentration in plasma (Cmax)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to the maximum concentration in plasma (tmax)</measure>
    <time_frame>up to 48 hours drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve in plasma (AUC)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant of in plasma (λz)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent terminal half-life in plasma (t1/2)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total mean residence time in the body (MRTtot)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total clearance in plasma after extravascular administration (CL/F)</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 (Vz/F)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount excreted into urine (Ae)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance (CLR)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of dose-proportionality of epinastine nasal</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
    <description>based on AUC and Cmax</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Epinastine nasal</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>Epinastine nasal</intervention_name>
    <arm_group_label>Epinastine nasal</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;
          -  All participants in the study should be healthy, range from 21 to 50 years of age and&#xD;
             be within ± 20 % of their normal weight (Broca -Index)&#xD;
&#xD;
          -  Subsequently each subject will have his medical history taken and will receive a&#xD;
             complete medical examination (incl. blood pressure and pulse rate measurements) as&#xD;
             well as a 12-lead ECG. Haematological, hepatic and renal function tests will be&#xD;
             carried out in the laboratory (Bioscientia Ingelheim, Germany). The subjects will fast&#xD;
             for 12 hours before collection of specimens for all laboratory evaluations. The above&#xD;
             mentioned examinations will be performed within 14 days before the first&#xD;
             administration of the test substance&#xD;
&#xD;
          -  In accordance with good clinical practice (GCP) and the local legislation all&#xD;
             volunteers will have given their written informed consent prior to admission to the&#xD;
             study&#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 the gastro-intestinal 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;
             to the trial as judged by the investigator&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 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;
          -  Use of any drugs which might influence the results of the trial (≤ one week prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (≤ two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &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 (≥ 100 mL within four weeks prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Excessive physical activities (within the last week before the study)&#xD;
&#xD;
          -  Any laboratory value outside the reference range of clinical relevance&#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>Epinastine</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/NCT02260037
org study id: 262.261
nct id: NCT02260037
lead sponsor: 
Safety, tolerability and pharmacokinetics
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with clinically relevant findings in vital signs
time frame: up to 8 days after drug administration
description: blood pressure, pulse rate
measure: Number of patients with clinically relevant findings in 12-lead ECG
time frame: up to 8 days after drug administration
measure: Number of patients with adverse events
time frame: up to 8 days after drug administration
measure: Number of patients with clinically relevant findings in laboratory parameters
time frame: up to 8 days after drug administration
measure: Changes in rhinoscopy assessment
time frame: up to 8 days after drug administration
measure: Maximum measured concentration in plasma (Cmax)
time frame: up to 48 hours after drug administration
measure: Time from dosing to the maximum concentration in plasma (tmax)
time frame: up to 48 hours drug administration
measure: Area under the concentration-time curve in plasma (AUC)
time frame: up to 48 hours after drug administration
measure: Terminal rate constant of in plasma (λz)
time frame: up to 48 hours after drug administration
measure: Apparent terminal half-life in plasma (t1/2)
time frame: up to 48 hours after drug administration
measure: Total mean residence time in the body (MRTtot)
time frame: up to 48 hours after drug administration
measure: Total clearance in plasma after extravascular administration (CL/F)
time frame: up to 48 hours after drug administration
measure: Apparent volume of distribution during the terminal phase (Vz/F)
time frame: up to 48 hours after drug administration
measure: Amount excreted into urine (Ae)
time frame: up to 48 hours after drug administration
measure: Renal clearance (CLR)
time frame: up to 48 hours after drug administration
measure: Assessment of dose-proportionality of epinastine nasal
time frame: up to 48 hours after drug administration
description: based on AUC and Cmax
arm group label: Epinastine nasal
arm group type: Experimental
description: single rising doses
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Epinastine nasal
arm group label: Epinastine nasal
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
mesh term: Epinastine