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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03826537




Registration number
NCT03826537
Ethics application status
Date submitted
5/08/2012
Date registered
31/01/2019
Date last updated
31/01/2019

Titles & IDs
Public title
A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body
Scientific 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
Secondary ID [1] 0 0
CH-1101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tutin Poisoning 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Poisoning

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Honey substance

Other: Honey substance - 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.


Other interventions: Honey substance
Honey substance containing 5.1 mg/kg tutin and 23 mg/kg hyenanchin

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetics of tutin and hyenanchin (Tmax) - Time to maximum plasma concentration (Tmax)
Timepoint [1] 0 0
Pre-dose through to 24 hours post dose. May be modified according to sentinal PK results.
Primary outcome [2] 0 0
Pharmacokinetics of tutin and hyenanchin (AUC) - Area under the plasma concentration versus time curve (AUC)
Timepoint [2] 0 0
Pre-dose through to 24 hours post dose
Primary outcome [3] 0 0
Pharmacokinetics of tutin and hyenanchin (Cmax) - Peak Plasma Concentration (Cmax)
Timepoint [3] 0 0
Pre-dose through to 24 hours post dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Health Services Research
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Christchurch Clinical Studies Trust Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03826537
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chris Wynne, MBChB
Address 0 0
Christchurch Clinical Studies Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications