ISRCTN27662176已完成未知
A randomised, open-label, parallel-group study in adult smokers to evaluate changes in biomarkers of tobacco exposure after switching to exclusive use of the JUUL2 system
Juul (United States)0 个研究点目标入组 96 人开始时间: 2022年9月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult male or female daily smoker, 21 to 65 years of age, inclusive, at Screening
- •2. Has been a smoker for at least 12 months prior to Screening. Brief periods of non-smoking (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) during that time will be permitted at the discretion of the Investigator
- •3. Currently smokes an average of 10 or more conventional manufactured combustible cigarettes per day, as reported at Screening
排除标准
- •1. Has a history of everyday or some day use of vapour products or use of any vapour products within 2 weeks of Screening
- •2. Has a history or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, haematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardise the safety of the subject or impact the validity of the study results
- •3. Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, electrocardiogram (ECG), or clinical laboratory results, in the opinion of the Investigator
- •4. Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- •5. Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 14 days prior to Check-in
- •6. Has a fever (>38°C) at Screening or Check-in
- •7. Has a body mass index (BMI) >40 kg/m² or <18 kg/m² at Screening
- •8. Has a history of drug or alcohol abuse within 24 months of Check-in
- •9. Has diabetes mellitus, asthma, or chronic obstructive pulmonary disease
- •10. Has a systolic blood pressure <90 mmHg or >150 mmHg, diastolic blood pressure <40 mmHg or > 95 mmHg, or heart rate <40 bpm or >99 bpm
- •11. Has experienced an allergic reaction following previous e-cigarette use or with exposure to benzoic acid, propylene glycol and glycerol
- •12. Has an estimated creatinine clearance <80 ml/minute (using the Cockcroft-Gault equation) at Screening
- •13. Has a positive urine screen for drugs of abuse or positive breath screen for alcohol at Screening or Day -2 (Check-in)
- •14. If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study
- •15. Has used medications known to interact with cytochrome P450 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, buprenorphine, clofibrate, clotrimazole, clozapine, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, ketoconazole, letrozole, methimazole, methoxsalen, metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyphene, quinidine, rifampicin, rifampin, ropinirole, secobarbital, selegiline, sulconazole, theophylline, tioconazole, tranylcypromine) within 14 days or 5 half-lives of the drug, whichever is longer, prior to Check-in.
- •16. Has used nicotine-containing products other than manufactured cigarettes or ENDS (e.g., roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) within 30 days prior to Check-in, except as required per protocol (e.g., the brief product trial at Screening Visit 2)
- •17. Has used any prescription smoking abstinence treatments, including, but not limited to, varenicline (Chantix®) or buproprion (Zyban®) within 3 months prior to Check-in
- •18. Is a self-reported puffer (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale)
- •19. Is planning to quit smoking during
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