Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03826537
Registration number
NCT03826537
Ethics application status
Date submitted
5/08/2012
Date registered
1/02/2019
Date last updated
1/02/2019
Titles & IDs
Public title
A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body
Query!
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
Query!
Secondary ID [1]
0
0
CH-1101
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Tutin Poisoning
0
0
Query!
Condition category
Condition code
Injuries and Accidents
0
0
0
0
Query!
Poisoning
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Pharmacokinetics of tutin and hyenanchin (Tmax)
Query!
Assessment method [1]
0
0
Time to maximum plasma concentration (Tmax)
Query!
Timepoint [1]
0
0
Pre-dose through to 24 hours post dose. May be modified according to sentinal PK results.
Query!
Primary outcome [2]
0
0
Pharmacokinetics of tutin and hyenanchin (AUC)
Query!
Assessment method [2]
0
0
Area under the plasma concentration versus time curve (AUC)
Query!
Timepoint [2]
0
0
Pre-dose through to 24 hours post dose
Query!
Primary outcome [3]
0
0
Pharmacokinetics of tutin and hyenanchin (Cmax)
Query!
Assessment method [3]
0
0
Peak Plasma Concentration (Cmax)
Query!
Timepoint [3]
0
0
Pre-dose through to 24 hours post dose
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
55
Years
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
Yes
Query!
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.
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/04/2012
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
6
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
New Zealand
Query!
State/province [1]
0
0
Canterbury
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Christchurch Clinical Studies Trust Ltd
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03826537
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Chris Wynne, MBChB
Query!
Address
0
0
Christchurch Clinical Studies Trust
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03826537
Download to PDF