ISRCTN13439529已完成未知
An assessment of nicotine kinetics and liking profiles of two tobacco heating products in comparison to combustible cigarettes and a nicotine replacement therapy
British American Tobacco (Investments) Ltd0 个研究点目标入组 32 人开始时间: 2018年8月7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
- 32
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36038580/ (added 01/09/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent form (ICF)
- •2. Aged 19-60 years old
- •3. Body mass index (BMI) of 18.5 to 30.0 kg/m², inclusive, and a body weight of at least 52 kg for males and 45 kg for females
- •4. Current smokers:
- •4.1. At least 10 cigarettes per day
- •4.2. Smoke conventional factory-made cigarettes
- •4.3. eCO = 10 ppm
- •4.4. Urinary cotinine = 200 ng/ml at screening
- •5. Current smokers of non-menthol cigarettes
- •6. Smoked their chosen brand for a minimum of 6 months and must have smoked for at least one year prior to screening
- •7. Normal (or abnormal and not clinically significant) laboratory values (biochemistry, haematology, urinalysis) at screening
- •8. Normal (or abnormal and not clinically significant) 12-lead ECG at screening
- •9. Normal (or abnormal and not clinically significant) findings at the screening physical examination
- •10. Willing to refrain from performing vigorous exercise for 2 days outside of their normal routine before screening and for the total study duration
- •11. Willing to abstain from alcohol for 24 hours before screening and the in-clinic evaluation;
- •12. Willing to avoid eating foods containing poppy seeds for 72 hours prior to screening and the in-clinic evaluation;
- •13. No childbearing potential at the time of the study for female participants (female participants of childbearing potential (i.e. not in menopausal status from at least one year or permanently sterilised) must have a negative serum pregnancy test at screening (to be confirmed by urine pregnancy test at each of the four study visits))
- •14. Ability to understand the requirements of the investigation
- •15. Willing to comply with all investigation procedures.
排除标准
- •1. Acute illness (e.g. upper respiratory tract infection, viral infection, etc) requiring treatment within 4 weeks prior to screening
- •2. Used any nicotine or tobacco product other than commercially-manufactured cigarettes within 14 days prior to screening
- •3. Self-reported non-inhalers (smokers who draw smoke from the cigarette into the mouth and throat but who do not inhale)
- •4. Medical history of asthma or chronic obstructive pulmonary disease (COPD)
- •5. Used prescription or over-the-counter (OTC) bronchodilator medication (e.g. inhaled or oral ß-adrenergic agonists or anticholinergic agents) to treat a chronic condition within the 12 months prior to screening
- •6. Received any medications or substances 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
- •7. Donated any of the following:
- •7.1. = 450 ml of blood within 90 days prior to screening
- •7.2. Plasma in the 7 days prior to screening
- •7.3. Platelets in the 6 weeks prior to screening
- •8. Perform strenuous physical activity (exceeding the subject’s normal activity levels) within 2 days prior to screening and the in-clinic evaluation
- •9. Medical history of any surgical or medical condition which, in the opinion of the investigator may interfere with participation in the investigation, or may jeopardize the safety of the subject or their compliance with the protocol, or may otherwise affect the outcome of the investigation
- •10. Any relevant surgical treatment during the previous 3 months or planned during the investigation
- •11. Medical history of serious psychiatric disorders
- •12. Serum hepatitis, carriers of the hepatitis B surface antigen (HBsAg), carriers of the hepatitis C antibody or a positive result for the test for human immunodeficiency virus (HIV) antibodies
- •13. Pulmonary function tests showing a forced expiratory volume after 1 second [FEV1]/forced vital capacity [FVC] < 0.7, FEV1 < 80% predicted value, and FVC < 80% predicted value
- •14. Abnormal QTcB interval value in the 12-lead ECG at screening (i.e. > 470 msec in both males or females)
- •15. Intake of illicit drugs within 6 months prior to screening, as determined by the investigator, or positive urine drug screen at screening
- •16. History of alcohol abuse within 6 months prior to screening, as determined by the investigator, or positive alcohol screen at screening (alcohol screen may be performed via a breath test)
- •17. Pregnant or lactating women at screening
- •18. Women physiologically capable of becoming pregnant during the overall investigation duration, unless willing to use a highly effective method of contraception. Highly effective birth control methods include:
- •18.1. Combined hormonal contraception (containing oestrogen and progestogen) associated with the inhibition of ovulation (oral, intravaginal, transdermal)
- •18.2. Progestogen-only hormonal contraception associated with the inhibition of ovulation (oral, injectable, implantable)
- •18.3. Intrauterine device (IUD)
- •18.4. Intrauterine hormone-releasing system (IUS)
研究者
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