ISRCTN58921739已完成未知
A cross-sectional study to assess biomarkers of exposure and biomarkers of potential harm in solus users of Vype ePen 3 and ePod products
British American Tobacco (United Kingdom)0 个研究点目标入组 222 人开始时间: 2021年1月14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
- 222
研究概览
简要总结
2022 Protocol article in https://www.sciencepublishinggroup.com/journal/paperinfo?journalid=344&doi=10.11648/j.jher.20220802.17 (added 14/07/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37249753/ (added 20/06/2023)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •All Subjects:
- •1. Subjects will be:
- •1.1.Males or females
- •1.2. 19 to 55 years of age, inclusive, demonstrated by appropriate proof of identification
- •2. Subjects will have a:
- •2.1. Body mass index (BMI) of 18.5 to 30.0 kg/m², inclusive
- •2.2. Body weight exceeding 52 kg (males) or 45 kg (females)
- •3. Subjects will be in good health, as judged by the PI or the appropriately qualified designee based on:
- •3.1.Medical history (confirmed by volunteer)
- •3.2.Physical examination
- •3.3. Vital signs assessment
- •3.4. 12-lead ECG
- •3.5.Clinical laboratory evaluations
- •3.6. Lung function tests/spirometry at screening
- •4. Subjects will have given their written informed consent to participate in the study and will have agreed to abide by the study restrictions
- •5. Subjects must demonstrate the ability to comprehend the informed consent form (ICF), be able to communicate well with the PI or the appropriately qualified designee, understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the PI or the appropriately qualified designee
- •6. Subjects will refrain from consuming alcohol within 24 hours prior to Screening
- •7. Subjects will refrain from consuming cruciferous vegetables, and grilled, fried or barbequed food, and avoid being in the presence of the cooking of cruciferous vegetables, and grilled, fried or barbequed food for 48 hours prior to Screening
- •Additional criteria for Arm A subjects only:
- •8. Subjects will be regular (daily) users of the Vype ePen 3 and/or Vype ePod vaping devices
- •9. Subjects will have used the Vype ePen 3 and/or Vype ePod vaping devices for a minimum of 6 months prior to Screening
- •10. Subjects will have a urine cotinine level > 200 ng/mL and an exhaled breath CO level < 7 ppm at Screening
- •Additional criteria for Arm B subjects only:
- •11. Subjects will be regular smokers of commercially manufactured filter cigarettes
- •12. Subjects will have smoked for at least one year prior to Screening
- •13. Subjects will typically smoke at least 10 CPD and must have a urine cotinine level >200ng/ml and an exhaled breath CO level =7 ppm at Screening
- •Additional criteria for Arm C subjects only:
- •14. Subjects will be former smokers of commercially manufactured filter cigarettes who quit smoking at least 6 months prior to Screening
- •15. Subjects will have a urine cotinine level < 200 ng/ml and an exhaled breath CO level <7 ppm at Screening
- •Additional criteria for Arm D subjects only:
- •16. Subjects will have never smoked (<100 cigarettes in their life and none within the six months prior to Screening)
- •17. Subjects will have a urine cotinine level < 200 ng/ml and an exhaled breath CO level <7 ppm at Screening
排除标准
- •All Subjects:
- •1. Female subjects who are pregnant or breastfeeding. This will be confirmed at Screening
- •2. Subjects who have donated:
- •2.1. =400 ml of blood within 90 days prior to screening
- •2.2. Plasma in the 7 days prior to screening
- •2.3. Platelets in the 6 weeks prior to screening
- •3. Subjects who have had an acute illness (e.g. upper respiratory tract infection, viral infection, etc.) requiring treatment within 4 weeks prior to screening
- •4. Subjects who have a significant history of alcoholism or drug/chemical abuse (apart from known smoking/vaping history) within 24 months prior to Screening, as determined by the PI or the appropriately qualified designee
- •5. Subjects who have a positive urine drugs of abuse or breath alcohol screen (confirmed by repeat) at Screening
- •6. Subjects who:
- •6.1. Have serum hepatitis/are carriers of the hepatitis B surface antigen (HBsAg)
- •6.2. Are carriers of the hepatitis C antibody
- •6.3. Have a positive result for the test for human immunodeficiency virus (HIV) antibodies
- •6.4. have a positive result in the COVID test at screening indicating current, active infection
- •7. Subjects who have 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
- •8. Subjects who have received any medications or substances (other than nicotine) which:
- •8.1. Interfere with the cyclooxygenase pathway (e.g. anti-inflammatory drugs including aspirin and ibuprofen) within 14 days prior to Screening
- •8.2. 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
- •9. Subjects who would need to take prescription medication during the period beginning with screening and ending with discharge
- •10. Subjects who are unwilling or unable to comply with the study requirements
- •11. Employees and immediate relatives of the tobacco industry or the clinical site
- •12. Subjects who have 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
- •13. Subjects who have been diagnosed with a significant history of urticaria or asthma (childhood asthma is acceptable)
- •14. Subjects who have, or who have a history of, any clinically significant neurological, gastrointestinal, renal (including urinary tract infection or nephrolithiasis), hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorder that, in the opinion of the PI or the appropriately qualified designee, would jeopardise the safety of the subject or impact on the validity of the study results
- •15. Subjects who have previously been diagnosed with any form of malignancy
- •16. Subjects who are currently participating in another clinical trial (including follow-up)
- •17. Subjects who, in the opinion of the PI or the appropriately qualif
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