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

Tutin Poisoning Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01531556
• Other study ID #: CH-1101
• Status: Recruiting
• Phase: Phase 1
• First received: February 6, 2012
• Last updated: February 10, 2012
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: February 2012
• Source: Food Standards Australia New Zealand
• Contact: Chris Wynne, MBChB
• Phone: +6433729477
• Is FDA regulated: No
• Health authority: New Zealand: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Honey available in New Zealand 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 Food Standards Australia New Zealand (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 consume, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria

• Healthy males, aged 18 to 55 years, body mass index of 18 - 32 kg/m2

• Healthy on the basis of medical history and screening assessments

• Agree to abstain from alcohol consumption as required per protocol

• Able to participate, willing to give written informed consent and willing to comply with study rules

Exclusion Criteria

• History of clinically relevant medical disorders

• Any gastrointestinal disorder or previous surgery that may affect absorption of study product.

• History of significant gastro-esophageal reflux disease or peptic ulcer disease.

• Significant neurological history

• Known allergy or hypersensitivity to honey

• Sustained blood pressure or heart rate recordings outside of range specified per protocol

• Clinically significant laboratory abnormality, or positive serology, drugs of abuse or alcohol screens.

• Smokers of >10 cigarettes/day within 3 months, and unable to stop smoking during 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 exclusion period specified per protocol

• Consumption of food or beverages containing honey, within 72 hours prior to dosing

• Known or suspected previous tutin poisoning

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Tutin Poisoning

Intervention

Other:
• Honey spiked with known concentration of tutin and hyenanchin
Prepared honey will contain 5.1 mg/kg tutin and 23 mg/kg hyenanchin; honey dose will be calculated based on body weight, such that each subject receives 1.8 mcg per kg body weight of tutin.

Locations

Country	Name	City	State
New Zealand	Christchurch Clinical Studies Trust Ltd	Christchurch	Canterbury

Sponsors (2)

Lead Sponsor	Collaborator
Food Standards Australia New Zealand	Christchurch Clinical Studies Trust Ltd

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve (AUC) of tutin and hyenanchin		pre-dose (within 30 minutes prior to dosing) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose	No
Primary	maximum observed concentration (cmax)of tutin and hyenanchin		pre-dose (within 30 minutes prior to dosing) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose	No
Primary	time to reach maximum concentration (tmax) of tutin and hyenanchin		pre-dose (within 30 minutes prior to dosing) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose	No
Primary	terminal half-life (t½) of tutin and hyenanchin		pre-dose (within 30 minutes prior to dosing) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose	No