ISRCTN55307091已完成未知
A randomised controlled single centre open-label pharmacokinetic study to examine nicotine delivery from different variants of an e-cigarette and a conventional cigarette in healthy subjects
British American Tobacco (Investments) Ltd0 个研究点目标入组 24 人开始时间: 2018年11月8日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
2020 Results article in https://doi.org/10.1038/s41598-020-76610-4 results (added 24/11/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 19-60 (demonstrated by government issued proof of identification)
- •2. Body mass index (BMI) of 18.5-30.0 kg/m², inclusive
- •3. Body weight exceeding 52 kg for males or 45 kg for females
- •4. In good health, as judged by the PI or the appropriately qualified designee based on:
- •4.1. Medical history (confirmed by volunteer)
- •4.2. Physical examination
- •4.3. Vital signs assessment
- •4.4. 12-lead ECG
- •4.5. Clinical laboratory evaluations
- •4.6. Lung function tests
- •5. Written informed consent to participate in the study and will have agreed to abide by the study restrictions
- •6. Ability to comprehend the informed consent form (ICF), ability to communicate well with the PI or the appropriately qualified designee, understand and comply with the requirements of the study, and judged suitable for the study in the opinion of the PI or the appropriately qualified designee
- •7. Willing to refrain from consuming alcohol within 24 hours prior to admission
- •8. Prior to study start, subjects must be current daily users of e-cigarettes and current smokers of conventional factory-made cigarettes, and must have done so for at least 1 year. Product use status will be confirmed with a urinary cotinine level of =200 ng/ml and a product use history questionnaire at screening. Subjects must be smoking a maximum of 21 per week of 6-10 mg ISO tar cigarettes
- •9. E-Cigarette users e-liquid must contain at least 18 mg/ml nicotine
- •10. Willing to use the study products (cigarette product or e cigarette) and use only the products provided to them during clinical confinement, and to abstain from product use when instructed
- •11. Women of non-childbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year and must have a negative urine pregnancy test result during screening. Women who are surgically sterile must provide documentation of the procedure by an operative report.
排除标准
- •1. Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a barrier method of contraception (i.e., a condom with spermicide) in addition to a second highly effective method of contraception used by their female partners or to refrain from donating sperm from admission (day -1) until end of follow-up period
- •2. Female subjects of childbearing potential who do not agree to use a highly effective method of birth control in conjunction with male barrier method contraception (i.e. a condom with spermicide) from the time of signing the ICF until end of follow-up period
- •3. Female subjects who are pregnant or breastfeeding. This will be confirmed at screening and admission. Any female subject who becomes pregnant during this study will be withdrawn
- •4. Donated:
- •4.1 =400 ml of blood within 90 days prior to screening
- •4.2 Plasma in the 7 days prior to screening
- •4.3 Platelets in the 6 weeks prior to screening
- •5. Acute illness (e.g. upper respiratory tract infection, viral infection) requiring treatment within 4 weeks prior to screening
- •6. Self-reported non-inhalers (smokers/vapers who draw smoke/aerosol from the cigarette/e-cigarette into the mouth and throat but who do not inhale). Subjects who are observed as non-inhalers at admission by the clinic staff will be excluded
- •7. Planning to quit smoking/vaping in the next 12 months, prior to enrolment. All subjects will be informed that they are free to quit smoking/vaping and withdraw from the study at any time
- •8. Significant history of alcoholism or drug/chemical abuse within 24 months prior to screening, as determined by the PI or the appropriately qualified designee
- •9. Positive urine drugs of abuse or alcohol screen (confirmed by repeat) at screening or admission
- •10. Serum hepatitis
- •11. Carriers of the hepatitis B surface antigen (HBsAg)
- •12. Carriers of the hepatitis C antibody
- •13. Positive result for the test for human immunodeficiency virus (HIV) antibodies
- •14. Used prescription or over-the-counter (OTC) bronchodilator medication (e.g. inhaled or oral ß-adrenergic agonists) to treat a chronic condition within the 12 months prior to screening
- •15. Received any medications or substances (other than tobacco) which are known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 half-lives of the drug (whichever is longer) prior to screening
- •16. Perform strenuous physical activity (exceeding their normal activity levels) within 7 days prior to screening or admission
- •17. Employees and immediate relatives of the tobacco industry or the clinical site
- •18. Participation in a new chemical entity clinical study within the previous 3 months or a marketed drug clinical study within the 30 days before first dose of IMP
- •19. Any clinically relevant abnormal findings on the physical examination, medical history, ECG, lung function tests or clinical laboratory panel, unless deemed not clinically significant by the PI or the appropriately qualified designee
- •20. No use of a flavoured e-cigarette e-liquid
- •21. Diagnosed with a significant history of urticaria or asthm
研究者
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