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A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body

Primary Purpose

Tutin Poisoning

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Honey substance
Sponsored by
Christchurch Clinical Studies Trust Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tutin Poisoning

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy males, aged between 18 and 55 years, inclusive.
  2. Healthy on the basis of medical history and screening assessments.
  3. Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive.
  4. Agree to abstain from alcohol consumption from 48 hours before dosing through to the completion of pharmacokinetic samples.
  5. Able to participate, and willing to give written informed consent and to comply with the study protocol requirements.

Exclusion Criteria:

  1. A history of clinically relevant cardiovascular, gastrointestinal, hepatic, renal,endocrine, pulmonary, neurological, psychiatric, allergic or skin disorders.
  2. Any gastrointestinal condition, disorder or previous surgery that, in the opinion of the investigator, may interfere with absorption of study product.
  3. History of or symptoms suggestive of significant gastro-esophageal reflux disease or peptic ulcer disease.
  4. Significant neurological history, including relevant history of seizure disorders, major head trauma or cerebrovascular disease.
  5. Known allergy or hypersensitivity to honey.
  6. Sustained blood pressure levels at screening of < 90 mmHg or > 150 mmHg for SBP or < 50 mmHg or >90 mmHg for DBP.
  7. Sustained resting heart rate (HR) > 100 or < 40 beats per minute (bpm) at screening.
  8. Clinically significant abnormalities in laboratory test results at screening or baseline.
  9. Positive serology screen for HIV, or Hepatitis B or C at screening.
  10. Positive results on urine drug / alcohol test at screening or Day 1 (if performed).
  11. Smokers of >10 cigarettes/day within 3 months prior to admission and unable to stop smoking during the study.
  12. Participation in an investigational drug study within 1 month prior to dosing.
  13. Blood or plasma donation of > 500 mL within the 3 months prior to dosing.
  14. Prescription or herbal remedies taken within 7 days or 5 half-lives (whichever is longer) prior to dosing. Over-the-counter medications and vitamins are not permitted within 72 hours prior to dosing. Paracetamol is permitted as required throughout the study, to a maximum of 4 grams per day.
  15. Consumption of food or beverages containing honey within 72 hours prior to dosing.
  16. Known or suspected previous tutin poisoning.

Sites / Locations

  • Christchurch Clinical Studies Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Honey substance

Arm 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.

Outcomes

Primary Outcome Measures

Pharmacokinetics of tutin and hyenanchin (Tmax)
Time to maximum plasma concentration (Tmax)
Pharmacokinetics of tutin and hyenanchin (AUC)
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics of tutin and hyenanchin (Cmax)
Peak Plasma Concentration (Cmax)

Secondary Outcome Measures

Full Information

First Posted
August 5, 2012
Last Updated
January 31, 2019
Sponsor
Christchurch Clinical Studies Trust Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03826537
Brief Title
A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christchurch Clinical Studies Trust Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tutin Poisoning

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Honey substance
Arm Type
Other
Arm 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(s)
Honey substance
Intervention Description
Honey substance containing 5.1 mg/kg tutin and 23 mg/kg hyenanchin
Primary Outcome Measure Information:
Title
Pharmacokinetics of tutin and hyenanchin (Tmax)
Description
Time to maximum plasma concentration (Tmax)
Time Frame
Pre-dose through to 24 hours post dose. May be modified according to sentinal PK results.
Title
Pharmacokinetics of tutin and hyenanchin (AUC)
Description
Area under the plasma concentration versus time curve (AUC)
Time Frame
Pre-dose through to 24 hours post dose
Title
Pharmacokinetics of tutin and hyenanchin (Cmax)
Description
Peak Plasma Concentration (Cmax)
Time Frame
Pre-dose through to 24 hours post dose

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy males, aged between 18 and 55 years, inclusive. Healthy on the basis of medical history and screening assessments. Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive. Agree to abstain from alcohol consumption from 48 hours before dosing through to the completion of pharmacokinetic samples. Able to participate, and willing to give written informed consent and to comply with the study protocol requirements. Exclusion Criteria: A history of clinically relevant cardiovascular, gastrointestinal, hepatic, renal,endocrine, pulmonary, neurological, psychiatric, allergic or skin disorders. Any gastrointestinal condition, disorder or previous surgery that, in the opinion of the investigator, may interfere with absorption of study product. History of or symptoms suggestive of significant gastro-esophageal reflux disease or peptic ulcer disease. Significant neurological history, including relevant history of seizure disorders, major head trauma or cerebrovascular disease. Known allergy or hypersensitivity to honey. Sustained blood pressure levels at screening of < 90 mmHg or > 150 mmHg for SBP or < 50 mmHg or >90 mmHg for DBP. Sustained resting heart rate (HR) > 100 or < 40 beats per minute (bpm) at screening. Clinically significant abnormalities in laboratory test results at screening or baseline. Positive serology screen for HIV, or Hepatitis B or C at screening. Positive results on urine drug / alcohol test at screening or Day 1 (if performed). Smokers of >10 cigarettes/day within 3 months prior to admission and unable to stop smoking during the study. Participation in an investigational drug study within 1 month prior to dosing. Blood or plasma donation of > 500 mL within the 3 months prior to dosing. Prescription or herbal remedies taken within 7 days or 5 half-lives (whichever is longer) prior to dosing. Over-the-counter medications and vitamins are not permitted within 72 hours prior to dosing. Paracetamol is permitted as required throughout the study, to a maximum of 4 grams per day. Consumption of food or beverages containing honey within 72 hours prior to dosing. Known or suspected previous tutin poisoning.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Wynne, MBChB
Organizational Affiliation
Christchurch Clinical Studies Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christchurch Clinical Studies Trust
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body

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