Status:
COMPLETED
A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body
Lead Sponsor:
Christchurch Clinical Studies Trust Ltd
Conditions:
Tutin Poisoning
Eligibility:
MALE
18-55 years
Phase:
NA
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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03826537
Start Date
January 1 2012
End Date
April 1 2012
Last Update
February 1 2019
Active Locations (1)
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1
Christchurch Clinical Studies Trust
Christchurch, Canterbury, New Zealand, 8011