<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/NCT02264080</url>
  </required_header>
  <id_info>
    <org_study_id>506.112</org_study_id>
    <nct_id>NCT02264080</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Safety of WAL2014 (Talsaclidine) Administered Orally to Healthy Adult Male Volunteers</brief_title>
  <official_title>Phase I Clinical Study of WAL2014 (Talsaclidine) Capsule: A Multiple Oral Dose Study</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 pharmacokinetics and safety of WAL2014 capsules administered orally as a&#xD;
      multiple dose to healthy adult male volunteers in double blind manner.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 1999</start_date>
  <primary_completion_date type="Actual">March 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>Maximum concentration of the analyte in plasma (Cmax)</measure>
    <time_frame>up to day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to reach maximum plasma concentration (tmax)</measure>
    <time_frame>up to day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC)</measure>
    <time_frame>up to day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary excretion rate</measure>
    <time_frame>up to day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Minimum plasma concentration (Cmin)</measure>
    <time_frame>up to day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>up to day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal half-life (t1/2)</measure>
    <time_frame>up to day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Distribution volume</measure>
    <time_frame>up to day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total clearance</measure>
    <time_frame>up to day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 22 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>WAL2014</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </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>WAL2014</intervention_name>
    <arm_group_label>WAL2014</arm_group_label>
    <other_name>Talsaclidine</other_name>
  </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;
        Subjects for the study are healthy male adult volunteers who meet all the inclusion&#xD;
        criteria listed below and do not fall into the exclusion criteria.&#xD;
&#xD;
          1. Age: 20-30 years old&#xD;
&#xD;
          2. Body weight: 50-80 kg&#xD;
&#xD;
          3. Obesity index: within +/-20% of the standard body weight [standard body weight =&#xD;
             (height - 100) x 0.9]&#xD;
&#xD;
          4. Those who have received screening examinations listed in Table 1 within one month&#xD;
             prior to the start of the clinical study and have been judged as eligible by the&#xD;
             investigator. Results of the simple test for gastric acidity are not used as the basis&#xD;
             of the judgment.&#xD;
&#xD;
          5. Those who belong to volunteer members' association which has an office in Clinical&#xD;
             Pharmacology Center, Ohsaki Clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those who have a history of allergic reaction or hypersensitivity to drugs&#xD;
&#xD;
          2. Those who have received any kind of drug(s) within one week prior to the&#xD;
             administration of the investigational product.&#xD;
&#xD;
          3. Those who have ingested alcoholic drink within two days before the administration of&#xD;
             the investigational product&#xD;
&#xD;
          4. Those who have been admitted to a hospital, undergone surgery or donated blood within&#xD;
             3 months before the administration of the investigational product&#xD;
&#xD;
          5. Those who have participated in a phase I clinical study of a drug which contains a new&#xD;
             active ingredient or a similar study within 4 months before the administration of the&#xD;
             investigational product&#xD;
&#xD;
          6. Those who participated in Phase I single dose study of the investigational product&#xD;
&#xD;
          7. Those who have a history of liver or renal disease&#xD;
&#xD;
          8. Those who are judged as ineligible for the clinical study by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 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 13, 2014</study_first_submitted>
  <study_first_submitted_qc>October 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 13, 2014</last_update_submitted>
  <last_update_submitted_qc>October 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 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/NCT02264080
org study id: 506.112
nct id: NCT02264080
lead sponsor: 
Study to assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a
      multiple dose to healthy adult male volunteers in double blind manner.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Maximum concentration of the analyte in plasma (Cmax)
time frame: up to day 14
measure: Time to reach maximum plasma concentration (tmax)
time frame: up to day 14
measure: Area under the plasma concentration-time curve (AUC)
time frame: up to day 14
measure: Urinary excretion rate
time frame: up to day 14
measure: Minimum plasma concentration (Cmin)
time frame: up to day 14
measure: Mean residence time (MRT)
time frame: up to day 14
measure: Terminal half-life (t1/2)
time frame: up to day 14
measure: Distribution volume
time frame: up to day 14
measure: Total clearance
time frame: up to day 14
measure: Number of subjects with adverse events
time frame: up to 22 days
arm group label: WAL2014
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: WAL2014
arm group label: WAL2014
other name: Talsaclidine
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor