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

This study is currently recruiting participants.
Verified February 2012 by Food Standards Australia New Zealand
Sponsor:
Collaborator:
Christchurch Clinical Studies Trust Ltd
Information provided by (Responsible Party):
Food Standards Australia New Zealand
ClinicalTrials.gov Identifier:
NCT01531556
First received: February 6, 2012
Last updated: February 10, 2012
Last verified: February 2012
History of Changes

February 6, 2012
February 10, 2012
January 2012
July 2012   (final data collection date for primary outcome measure)
  • Area under the concentration-time curve (AUC) of tutin and hyenanchin [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • maximum observed concentration (cmax)of tutin and hyenanchin [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • time to reach maximum concentration (tmax) of tutin and hyenanchin [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • terminal half-life (t½) of tutin and hyenanchin [ Time Frame: 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01531556 on ClinicalTrials.gov Archive Site
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A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body
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.

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.
Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Tutin Poisoning
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact: Chris Wynne, MBChB +6433729477
New Zealand
 
NCT01531556
CH-1101
Not Provided
Food Standards Australia New Zealand
Food Standards Australia New Zealand
Christchurch Clinical Studies Trust Ltd
Principal Investigator: Chris Wynne, MBChB Christchurch Clinical Studies Trust Ltd
Food Standards Australia New Zealand
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP