<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/NCT02264054</url>
  </required_header>
  <id_info>
    <org_study_id>506.109</org_study_id>
    <nct_id>NCT02264054</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Talsaclidine After Administration to Healthy Subjects</brief_title>
  <official_title>Investigation of Metabolism and Pharmacokinetics of Talsaclidine After Administration of Single Oral and Single Intravenous Dose of 20 mg of [14C]-Labelled Talsaclidine to 6 Healthy Subjects</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 investigate metabolism, pharmacokinetic, safety and tolerability of talsaclidine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>[C14]-radioactivity concentration in blood</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>[C14]-radioactivity concentration in plasma</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>[C14]-radioactivity concentration in urine</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal half-life (t1/2)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum concentration of the analyte in plasma (Cmax)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to reach maximum plasma concentration (tmax)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute bioavailability based on AUC</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Drug absorption (fa) based on radioactivity</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary excretion (Ae)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance (CL)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution (Vz/f))</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma protein binding of the [14C] radioactivity</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects 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 subjects with clinically significant findings in electrocardiogram</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in laboratory tests</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>[14C]talsaclidine, oral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose of 20 mg oral solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>[14C]talsaclidine, iv</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>single dose of 20 mg intravenous (iv) infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]talsaclidine, oral</intervention_name>
    <arm_group_label>[14C]talsaclidine, oral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]talsaclidine, iv</intervention_name>
    <arm_group_label>[14C]talsaclidine, iv</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males&#xD;
&#xD;
          -  Age range from 50 to 65 years&#xD;
&#xD;
          -  Participants should be within 20% of their normal weight (Broca-Index)&#xD;
&#xD;
          -  Written informed consent in accordance with Good Clinical Practice and local&#xD;
             legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Results of the medical examination or laboratory tests (especially those which&#xD;
             indicate liver malfunction) are judged by the clinical investigator to differ&#xD;
             significantly from normal clinical values&#xD;
&#xD;
          -  Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Disease of the central nervous system (such as epilepsy) or with psychiatric disorders&#xD;
&#xD;
          -  Known 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 (≥ 24 hours) within one month before enrolment&#xD;
             in the study&#xD;
&#xD;
          -  Intake of any other drugs which might influence the results of the trial during the&#xD;
             week previous the start of the study&#xD;
&#xD;
          -  Participation in another study with an investigational drug within the last 2 months&#xD;
             preceding this study&#xD;
&#xD;
          -  Unability to refrain from smoking on study days&#xD;
&#xD;
          -  Volunteers who smoke more than 10 cigarettes (or 3 cigars or pipes) per day&#xD;
&#xD;
          -  Volunteers who drink more than 40 g of alcohol per day&#xD;
&#xD;
          -  Volunteers who are dependent on drugs&#xD;
&#xD;
          -  Blood donation ((≥ 100 ml) within the last 4 weeks&#xD;
&#xD;
          -  Excessive physical activities (e.g. competitive sports) within the last week before&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 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/NCT02264054
org study id: 506.109
nct id: NCT02264054
lead sponsor: 
Study to investigate metabolism, pharmacokinetic, safety and tolerability of talsaclidine.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: [C14]-radioactivity concentration in blood
time frame: up to 96 hours after drug administration
measure: [C14]-radioactivity concentration in plasma
time frame: up to 96 hours after drug administration
measure: [C14]-radioactivity concentration in urine
time frame: up to 96 hours after drug administration
measure: Area under the plasma concentration-time curve (AUC)
time frame: up to 96 hours after drug administration
measure: Terminal half-life (t1/2)
time frame: up to 96 hours after drug administration
measure: Maximum concentration of the analyte in plasma (Cmax)
time frame: up to 96 hours after drug administration
measure: Time to reach maximum plasma concentration (tmax)
time frame: up to 96 hours after drug administration
measure: Absolute bioavailability based on AUC
time frame: up to 96 hours after drug administration
measure: Drug absorption (fa) based on radioactivity
time frame: up to 96 hours after drug administration
measure: Urinary excretion (Ae)
time frame: up to 96 hours after drug administration
measure: Mean residence time (MRT)
time frame: up to 96 hours after drug administration
measure: Apparent clearance (CL)
time frame: up to 96 hours after drug administration
measure: Apparent volume of distribution (Vz/f))
time frame: up to 96 hours after drug administration
measure: Plasma protein binding of the [14C] radioactivity
time frame: up to 96 hours after drug administration
measure: Number of subjects with adverse events
time frame: up to 8 days after last drug administration
measure: Number of subjects 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 subjects with clinically significant findings in electrocardiogram
time frame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
time frame: up to 8 days after last drug administration
arm group label: [14C]talsaclidine, oral
arm group type: Experimental
description: single dose of 20 mg oral solution
arm group label: [14C]talsaclidine, iv
arm group type: Active Comparator
description: single dose of 20 mg intravenous (iv) infusion
intervention type: Drug
intervention name: [14C]talsaclidine, oral
arm group label: [14C]talsaclidine, oral
intervention type: Drug
intervention name: [14C]talsaclidine, iv
arm group label: [14C]talsaclidine, iv
criteria: 
gender: Male
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor