<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/NCT01668199</url>
  </required_header>
  <id_info>
    <org_study_id>NPJ5004-03/2011 (MET)</org_study_id>
    <nct_id>NCT01668199</nct_id>
  </id_info>
  <brief_title>A Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery and Pharmacokinetics of 14C TZP-101</brief_title>
  <official_title>An Open-Label, Single-Dose, Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery and Pharmacokinetics of 14C TZP-101</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norgine</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norgine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to investigate the mass balance recovery and pharmacokinetics of 14C TZP-101.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics of total radioactivity in plasma</measure>
    <time_frame>6 weeks</time_frame>
    <description>To determine the pharmacokinetics of total radioactivity in plasma (Cmax, tmax, AUC, t1/2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of parent TZP-101 in plasma</measure>
    <time_frame>6 weeks</time_frame>
    <description>To determine the pharmacokinetics of parent TZP-101 in plasma (Cmax, tmax, AUC, t1/2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total radioactivity in urine and faeces</measure>
    <time_frame>6 weeks</time_frame>
    <description>To determine the Urine and faecal recovery of total radioactivity (Ae, Fe%, CLr)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total radioactivity in plasma</measure>
    <time_frame>6 weeks</time_frame>
    <description>To determine the Total radioactivity in plasma/total radioactivity in whole blood ratio at selected timepoints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total radioactivity of parent drug in plasma</measure>
    <time_frame>6 weeks</time_frame>
    <description>To determine the Total radioactivity in plasma/parent drug in plasma ratio for selected PK parameters</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Postoperative Ileus</condition>
  <arm_group>
    <arm_group_label>14C TZP-101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TZP-101</intervention_name>
    <arm_group_label>14C TZP-101</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Males&#xD;
&#xD;
          -  35-65 years of age&#xD;
&#xD;
          -  Body Mass Index (BMI) of 18-32 kg/m2 or, if outside the range, considered not&#xD;
             clinically significant by the investigator&#xD;
&#xD;
          -  Body weight of 75-90kg&#xD;
&#xD;
          -  Must be willing and able to communicate and participate in the whole study&#xD;
&#xD;
          -  Must provide written informed consent&#xD;
&#xD;
          -  Subject must agree to use adequate methods of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in a clinical research study within the previous 3 moths or more than 3&#xD;
             studies within the previous 12 months&#xD;
&#xD;
          -  Participation in an ADE study within the previous 12 months&#xD;
&#xD;
          -  History of any drug or alcohol abuse in the past 2 years&#xD;
&#xD;
          -  Regular alcohol consumption &gt;21 units per week&#xD;
&#xD;
          -  Current smokers and those who have smoked within the last 12 months, or a breath&#xD;
             carbon monoxide (CO) reading of greater than 10ppm at screening&#xD;
&#xD;
          -  Radiation exposure from clinical studies, including that from the present study,&#xD;
             excluding background radiation including diagnostic X-rays and other medical&#xD;
             exposures, exceeding 5 mSv in the last twelve months or 10 mSv in the last 5 years. No&#xD;
             occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999,&#xD;
             shall participate in the study&#xD;
&#xD;
          -  Clinically significant abnormal biochemistry, haematology or urinalysis at screening&#xD;
             as judged by the investigator&#xD;
&#xD;
          -  Clinically significant abnormal physical findings, ECG or vital signs measurements at&#xD;
             screening&#xD;
&#xD;
          -  PR interval 220 ms at screening or on admission&#xD;
&#xD;
          -  QTcB &gt;450 ms at screening or on admission&#xD;
&#xD;
          -  Existence of any surgical or medical condition that might interfere with the&#xD;
             absorption, distribution, metabolism or excretion of the IMP&#xD;
&#xD;
          -  History or presence of significant cardiovascular, respiratory, gastrointestinal&#xD;
             (especially peptic ulcer disease), neurological, psychiatric, metabolic, hepatic or&#xD;
             renal problems as judged by the investigator&#xD;
&#xD;
          -  Positive drugs of abuse test result&#xD;
&#xD;
          -  Positive HBV, HCV or HIV results&#xD;
&#xD;
          -  Use of prescription or non prescription drugs, including vitamins, herbal and dietary&#xD;
             supplements (including St. John's Wort) within 14 days of the planned IMP&#xD;
             administration unless in the opinion of the PI the medication will not interfere with&#xD;
             study procedures or compromise study safety&#xD;
&#xD;
          -  Serious adverse reaction or serious hypersensitivity to any drug or the formulation&#xD;
             excipients&#xD;
&#xD;
          -  Presence or history of allergy requiring treatment (seasonal allergic rhinitis&#xD;
             (hayfever) is allowed unless it is active)&#xD;
&#xD;
          -  Donation or loss of greater than 400 mL of blood within the previous three months&#xD;
&#xD;
          -  Subjects receiving or requiring prohibited medication as described in Section 11&#xD;
&#xD;
          -  Failure to satisfy the Investigator of fitness to participate for any other reason&#xD;
&#xD;
          -  Poor venous access&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip Evans, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quotient Clinical, Mere Way, Ruddlington Fields, Nottingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Clinical</name>
      <address>
        <city>Nottingham</city>
        <state>England</state>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>August 16, 2012</last_update_submitted>
  <last_update_submitted_qc>August 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2012</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/NCT01668199
org study id: NPJ5004-03/2011 (MET)
nct id: NCT01668199
lead sponsor: 
has dmc: No
A study to investigate the mass balance recovery and pharmacokinetics of 14C TZP-101.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetics of total radioactivity in plasma
time frame: 6 weeks
description: To determine the pharmacokinetics of total radioactivity in plasma (Cmax, tmax, AUC, t1/2)
measure: Pharmacokinetics of parent TZP-101 in plasma
time frame: 6 weeks
description: To determine the pharmacokinetics of parent TZP-101 in plasma (Cmax, tmax, AUC, t1/2)
measure: Total radioactivity in urine and faeces
time frame: 6 weeks
description: To determine the Urine and faecal recovery of total radioactivity (Ae, Fe%, CLr)
measure: Total radioactivity in plasma
time frame: 6 weeks
description: To determine the Total radioactivity in plasma/total radioactivity in whole blood ratio at selected timepoints
measure: Total radioactivity of parent drug in plasma
time frame: 6 weeks
description: To determine the Total radioactivity in plasma/parent drug in plasma ratio for selected PK parameters
arm group label: 14C TZP-101
arm group type: Experimental
intervention type: Drug
intervention name: TZP-101
arm group label: 14C TZP-101
criteria: 
gender: Male
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philip Evans, MD
role: Principal Investigator
affiliation: Quotient Clinical, Mere Way, Ruddlington Fields, Nottingham
facility: 
country: United Kingdom
responsible party type: Sponsor