<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/NCT03826537</url>
  </required_header>
  <id_info>
    <org_study_id>CH-1101</org_study_id>
    <nct_id>NCT03826537</nct_id>
    <nct_alias>NCT01531556</nct_alias>
  </id_info>
  <brief_title>A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body</brief_title>
  <official_title>An Open-label, Non-randomised Study to Investigate the Pharmacokinetics of Tutin and Hyenanchin, Following Single Dose Administration of Honey Containing Tutin and Hyenanchin to Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christchurch Clinical Studies Trust Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Christchurch Clinical Studies Trust Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Honey available in New Zeland can contain the toxins tutin and hyenanchin. Tutin is produced&#xD;
      by several plants native to New Zealand. Bees collect honeydew contaminated with tutin and&#xD;
      hyenanchin for honey production.&#xD;
&#xD;
      Honey contaminated with high levels of tutin has caused cases of poisoning in New Zealand&#xD;
      since the 1800s, with the most recent outbreak in 2008.&#xD;
&#xD;
      The study aims to find out how tutin and hyenanchin are absorbed and processed by the body.&#xD;
      This information will help the FSANZ give guidance on acceptable levels of tutin and&#xD;
      hyenanchin in honey.&#xD;
&#xD;
      About 6 healthy men will each take a single dose of honey containing known concentrations of&#xD;
      tutin and hyenanchin.&#xD;
&#xD;
      This dose level is similar to what someone who eats a lot of honey would have, if the honey&#xD;
      contained the maximum level of tutin allowed under the Food Standards Code.&#xD;
&#xD;
      Blood tests to measure tutin and hyenanchin levels will be taken at certain times after&#xD;
      dosing, and any side effects will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics of tutin and hyenanchin (Tmax)</measure>
    <time_frame>Pre-dose through to 24 hours post dose. May be modified according to sentinal PK results.</time_frame>
    <description>Time to maximum plasma concentration (Tmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of tutin and hyenanchin (AUC)</measure>
    <time_frame>Pre-dose through to 24 hours post dose</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of tutin and hyenanchin (Cmax)</measure>
    <time_frame>Pre-dose through to 24 hours post dose</time_frame>
    <description>Peak Plasma Concentration (Cmax)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Tutin Poisoning</condition>
  <arm_group>
    <arm_group_label>Honey substance</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Honey substance containing 5.1 mg/kg tutin and 23 mg/kg hyenanchin. Subjects to receive single dose of test material such that each subject receives 1.8 mcg/kg body weight of tutin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Honey substance</intervention_name>
    <description>Honey substance containing 5.1 mg/kg tutin and 23 mg/kg hyenanchin</description>
    <arm_group_label>Honey substance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males, aged between 18 and 55 years, inclusive.&#xD;
&#xD;
          2. Healthy on the basis of medical history and screening assessments.&#xD;
&#xD;
          3. Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive.&#xD;
&#xD;
          4. Agree to abstain from alcohol consumption from 48 hours before dosing through to the&#xD;
             completion of pharmacokinetic samples.&#xD;
&#xD;
          5. Able to participate, and willing to give written informed consent and to comply with&#xD;
             the study protocol requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A history of clinically relevant cardiovascular, gastrointestinal, hepatic,&#xD;
             renal,endocrine, pulmonary, neurological, psychiatric, allergic or skin disorders.&#xD;
&#xD;
          2. Any gastrointestinal condition, disorder or previous surgery that, in the opinion of&#xD;
             the investigator, may interfere with absorption of study product.&#xD;
&#xD;
          3. History of or symptoms suggestive of significant gastro-esophageal reflux disease or&#xD;
             peptic ulcer disease.&#xD;
&#xD;
          4. Significant neurological history, including relevant history of seizure disorders,&#xD;
             major head trauma or cerebrovascular disease.&#xD;
&#xD;
          5. Known allergy or hypersensitivity to honey.&#xD;
&#xD;
          6. Sustained blood pressure levels at screening of &lt; 90 mmHg or &gt; 150 mmHg for SBP or &lt;&#xD;
             50 mmHg or &gt;90 mmHg for DBP.&#xD;
&#xD;
          7. Sustained resting heart rate (HR) &gt; 100 or &lt; 40 beats per minute (bpm) at screening.&#xD;
&#xD;
          8. Clinically significant abnormalities in laboratory test results at screening or&#xD;
             baseline.&#xD;
&#xD;
          9. Positive serology screen for HIV, or Hepatitis B or C at screening.&#xD;
&#xD;
         10. Positive results on urine drug / alcohol test at screening or Day 1 (if performed).&#xD;
&#xD;
         11. Smokers of &gt;10 cigarettes/day within 3 months prior to admission and unable to stop&#xD;
             smoking during the study.&#xD;
&#xD;
         12. Participation in an investigational drug study within 1 month prior to dosing.&#xD;
&#xD;
         13. Blood or plasma donation of &gt; 500 mL within the 3 months prior to dosing.&#xD;
&#xD;
         14. Prescription or herbal remedies taken within 7 days or 5 half-lives (whichever is&#xD;
             longer) prior to dosing. Over-the-counter medications and vitamins are not permitted&#xD;
             within 72 hours prior to dosing. Paracetamol is permitted as required throughout the&#xD;
             study, to a maximum of 4 grams per day.&#xD;
&#xD;
         15. Consumption of food or beverages containing honey within 72 hours prior to dosing.&#xD;
&#xD;
         16. Known or suspected previous tutin poisoning.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris Wynne, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Christchurch Clinical Studies Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Christchurch Clinical Studies Trust</name>
      <address>
        <city>Christchurch</city>
        <state>Canterbury</state>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 5, 2012</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poisoning</mesh_term>
  </condition_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/NCT03826537
org study id: CH-1101
nct id: NCT03826537
nct alias: NCT01531556
lead sponsor: 
has dmc: No
Honey available in New Zeland can contain the toxins tutin and hyenanchin. Tutin is produced
      by several plants native to New Zealand. Bees collect honeydew contaminated with tutin and
      hyenanchin for honey production.

      Honey contaminated with high levels of tutin has caused cases of poisoning in New Zealand
      since the 1800s, with the most recent outbreak in 2008.

      The study aims to find out how tutin and hyenanchin are absorbed and processed by the body.
      This information will help the FSANZ give guidance on acceptable levels of tutin and
      hyenanchin in honey.

      About 6 healthy men will each take a single dose of honey containing known concentrations of
      tutin and hyenanchin.

      This dose level is similar to what someone who eats a lot of honey would have, if the honey
      contained the maximum level of tutin allowed under the Food Standards Code.

      Blood tests to measure tutin and hyenanchin levels will be taken at certain times after
      dosing, and any side effects will be recorded.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Pharmacokinetics of tutin and hyenanchin (Tmax)
time frame: Pre-dose through to 24 hours post dose. May be modified according to sentinal PK results.
description: Time to maximum plasma concentration (Tmax)
measure: Pharmacokinetics of tutin and hyenanchin (AUC)
time frame: Pre-dose through to 24 hours post dose
description: Area under the plasma concentration versus time curve (AUC)
measure: Pharmacokinetics of tutin and hyenanchin (Cmax)
time frame: Pre-dose through to 24 hours post dose
description: Peak Plasma Concentration (Cmax)
arm group label: Honey substance
arm group type: Other
description: Honey substance containing 5.1 mg/kg tutin and 23 mg/kg hyenanchin. Subjects to receive single dose of test material such that each subject receives 1.8 mcg/kg body weight of tutin.
intervention type: Other
intervention name: Honey substance
description: Honey substance containing 5.1 mg/kg tutin and 23 mg/kg hyenanchin
arm group label: Honey substance
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chris Wynne, MBChB
role: Principal Investigator
affiliation: Christchurch Clinical Studies Trust
facility: 
country: New Zealand
responsible party type: Sponsor
mesh term: Poisoning