<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/NCT01702194</url>
  </required_header>
  <id_info>
    <org_study_id>0087</org_study_id>
    <nct_id>NCT01702194</nct_id>
  </id_info>
  <brief_title>TD-1211 IV/Oral Mass Balance Study</brief_title>
  <official_title>A Single-Dose, Fixed-Sequence, Two-Period, Two-Treatment Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of TD-1211 Following an Intravenous Infusion and an Oral Dose of [14C]TD-1211 in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Theravance Biopharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Theravance Biopharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine TD-1211 is processed by the body.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will provide information regarding the metabolic pathway of TD 1211, the need for&#xD;
      evaluation of potential drug-drug interactions, the need for studies in special populations&#xD;
      and the absolute oral bioavailability of TD-1211. The administration of radiolabeled drug is&#xD;
      necessary to fully characterize the rates and routes of elimination of TD 1211, providing&#xD;
      further quantitative information on the disposition of TD 1211. The results from this study&#xD;
      will allow a more comprehensive comparison between animal and human routes of elimination and&#xD;
      metabolic profiles of TD 1211.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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 (AUC)</measure>
    <time_frame>0 to 168 hours postdose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak plasma concentration (Cmax)</measure>
    <time_frame>0 to 168 hours postdose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to peak plasma concentration (Tmax)</measure>
    <time_frame>0 to 168 hours postdose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Half-life (T 1/2)</measure>
    <time_frame>0 to 168 hours postdose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent total recovery of radioactivity in blood, urine, and feces</measure>
    <time_frame>0 to 312 hours postdose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Baseline to 14 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>OIC</condition>
  <arm_group>
    <arm_group_label>TD-1211 IV [C14]</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TD-1211 IV [C14]</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TD-1211 PO [C14]</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TD-1211 PO [C14]</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TD-1211 IV [C14]</intervention_name>
    <arm_group_label>TD-1211 IV [C14]</arm_group_label>
    <other_name>TD-1211</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TD-1211 PO [C14]</intervention_name>
    <arm_group_label>TD-1211 PO [C14]</arm_group_label>
    <other_name>TD-1211</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy, nonsmoking male, 18 to 50 years old, inclusive.&#xD;
&#xD;
          2. Agrees to use a highly effective method of birth control.&#xD;
&#xD;
          3. Body mass index (BMI) 19 to 30 kg/m2, inclusive, and weighs at least 55 kg.&#xD;
&#xD;
          4. Willing and able to give written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence or history of clinically significant allergic (except for untreated,&#xD;
             asymptomatic, seasonal allergies at time of dosing), hematological, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological&#xD;
             disease.&#xD;
&#xD;
          2. Hemoglobin &lt;14.1 g/dL or hematocrit &lt; 40.6% at Screening.&#xD;
&#xD;
          3. History of hypersensitivity to drugs, or a history of or any current clinically&#xD;
             significant hypersensitivities.&#xD;
&#xD;
          4. Any condition possibly affecting drug absorption (e.g., previous surgery on the&#xD;
             gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall&#xD;
             bladder, or pancreas]).&#xD;
&#xD;
          5. Participated in another clinical trial of an investigational drug (or medical device)&#xD;
             within 60 days (or 5 half-lives of the investigational drug, whichever is longer)&#xD;
             prior to Screening, or is currently participating in another trial of an&#xD;
             investigational drug (or medical device).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Monitor</last_name>
    <role>Study Director</role>
    <affiliation>Theravance Biopharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>January 15, 2021</last_update_submitted>
  <last_update_submitted_qc>January 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OIC</keyword>
  <keyword>Opioid Induced Constipation</keyword>
  <keyword>Constipation</keyword>
  <!-- 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/NCT01702194
org study id: 0087
nct id: NCT01702194
lead sponsor: 
has dmc: No
The purpose of this study is to determine TD-1211 is processed by the body.
This study will provide information regarding the metabolic pathway of TD 1211, the need for
      evaluation of potential drug-drug interactions, the need for studies in special populations
      and the absolute oral bioavailability of TD-1211. The administration of radiolabeled drug is
      necessary to fully characterize the rates and routes of elimination of TD 1211, providing
      further quantitative information on the disposition of TD 1211. The results from this study
      will allow a more comprehensive comparison between animal and human routes of elimination and
      metabolic profiles of TD 1211.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the plasma concentration versus time curve (AUC)
time frame: 0 to 168 hours postdose
measure: Peak plasma concentration (Cmax)
time frame: 0 to 168 hours postdose
measure: Time to peak plasma concentration (Tmax)
time frame: 0 to 168 hours postdose
measure: Half-life (T 1/2)
time frame: 0 to 168 hours postdose
measure: Percent total recovery of radioactivity in blood, urine, and feces
time frame: 0 to 312 hours postdose
measure: Number of participants with adverse events
time frame: Baseline to 14 days
arm group label: TD-1211 IV [C14]
arm group type: Experimental
description: TD-1211 IV [C14]
arm group label: TD-1211 PO [C14]
arm group type: Experimental
description: TD-1211 PO [C14]
intervention type: Drug
intervention name: TD-1211 IV [C14]
arm group label: TD-1211 IV [C14]
other name: TD-1211
intervention type: Drug
intervention name: TD-1211 PO [C14]
arm group label: TD-1211 PO [C14]
other name: TD-1211
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Monitor
role: Study Director
affiliation: Theravance Biopharma
facility: 
country: United States
responsible party type: Sponsor