Tutin PoisoningNCT03826537
A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body
A study testing Honey substance in people with Tutin Poisoning, run by Christchurch Clinical Studies Trust Ltd at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tutin Poisoning
- What is being tested?
- Honey substance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNew Zealand
- Study dates
- Jan 2012to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Christchurch Clinical Studies Trust
Christchurch, Canterbury, 8011
About this study
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
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.
Read more
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.
- Conditions
- Tutin Poisoning
- Being tested
- Honey substance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honey substanceOther
Honey substance containing 5.1 mg/kg tutin and 23 mg/kg hyenanchin
| Study group | Role | What they receive |
|---|---|---|
| Honey substance | Other | 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. Receives: Other: Honey substance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of tutin and hyenanchin (Tmax)
Time to maximum plasma concentration (Tmax)
Measured: Pre-dose through to 24 hours post dose. May be modified according to sentinal PK results.
Pharmacokinetics of tutin and hyenanchin (AUC)
Area under the plasma concentration versus time curve (AUC)
Measured: Pre-dose through to 24 hours post dose
Pharmacokinetics of tutin and hyenanchin (Cmax)
Peak Plasma Concentration (Cmax)
Measured: Pre-dose through to 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study startJan 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tutin PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christchurch Clinical Studies Trust Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Wynne, MBChB, Principal investigator, Christchurch Clinical Studies Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826537
- Sponsor's protocol ID
- CH-1101
- Status last verified
- Jan 2019
- First submitted
- 5 Aug 2012
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03826537
- Acronym / sponsor ID
- CH-1101
- Conditions
- Tutin Poisoning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Christchurch Clinical Studies Trust LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Honey substance | Other | Other: Honey substanceHoney 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Honey substanceHoney substance containing 5.1 mg/kg tutin and 23 mg/kg hyenanchin | Other | Honey substance |
Primary outcome
Pharmacokinetics of tutin and hyenanchin (Tmax)
Time frame: Pre-dose through to 24 hours post dose. May be modified according to sentinal PK results.
Time to maximum plasma concentration (Tmax)
Pharmacokinetics of tutin and hyenanchin (AUC)
Time frame: Pre-dose through to 24 hours post dose
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics of tutin and hyenanchin (Cmax)
Time frame: Pre-dose through to 24 hours post dose
Peak Plasma Concentration (Cmax)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Wynne, MBChB principal investigator
Christchurch Clinical Studies Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honey substance in people with Tutin Poisoning, run by Christchurch Clinical Studies Trust Ltd at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of tutin and hyenanchin (Tmax) (time frame: Pre-dose through to 24 hours post dose. May be modified according to sentinal PK results.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.