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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Pharmacokinetics of tutin and hyenanchin (Tmax)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Honey substance (Other)
结局指标
主要结局
Pharmacokinetics of tutin and hyenanchin (Tmax)
时间窗: 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)
时间窗: Pre-dose through to 24 hours post dose
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics of tutin and hyenanchin (Cmax)
时间窗: Pre-dose through to 24 hours post dose
Peak Plasma Concentration (Cmax)
次要结局
未报告次要终点