ISRCTN80651909已完成未知
A randomised controlled single-centre open-label study in healthy subjects to evaluate the effect on biomarkers of exposure of switching from a combustible cigarette to a Next Generation Product (NGP)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 148
研究概览
简要总结
2021 results in https://pubmed.ncbi.nlm.nih.gov/34026564/ (added 25/05/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males or females aged between 21 and 55 years of age, inclusive
- •2. Body mass index (BMI) of 18.5 to 30.0 kg/m2, inclusive; a body weight exceeding 52 kg (males) or 45 kg (females)
- •3. In good health, as judged by the PI or the appropriately qualified designee based on medical history, physical examination, vital signs assessment, 12-lead ECG, clinical laboratory evaluations, and lung function tests
- •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. Willing to refrain from consuming alcohol within 72 hours prior to Admission
- •7. Willing to 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 Admission
- •8. Subjects will be regular smokers of factory made, non-menthol cigarettes whose chosen brand is within the ISO tar bands 6 mg to 10 mg, inclusive
- •9. Subjects will have smoked their chosen brand for a minimum of 6 months and will have smoked for at least 3 years prior to Screening
- •10. Subjects will typically smoke 10 to 30 cigarettes per day, inclusive, and must have a urine cotinine level >200 ng/mL at Screening
- •11. Subjects will be willing to use the study products (comparator cigarette or THP product or e-cigarette) and use only the products provided to them during clinical confinement, or to abstain from smoking if assigned to the cessation arm
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 5 days after Discharge
- •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 5 days after Discharge
- •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. Subjects who have donated =400 mL of blood within 90 days prior to Admission, plasma in the 7 days prior to Admission, or platelets in the 6 weeks prior to Admission
- •5. Subjects who have an acute illness (e.g. upper respiratory tract infection. viral infection, etc.) requiring treatment within 4 weeks prior to Admission
- •6. Subjects who have used any nicotine or tobacco product other than commercially manufactured non-menthol, filter cigarettes within 14 days of Screening
- •7. Subjects who are self-reported non-inhalers (smokers who draw smoke from the 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
- •8. Subjects who, prior to enrolment, are planning to quit smoking in the next 12 months. All subjects will be informed that they are free to quit smoking and withdraw from the study at any time. Any subject who decides to quit smoking will be directed to appropriate stop smoking services
- •9. Subjects who have a significant history of alcoholism or drug/chemical abuse within 24 months prior to Screening, as determined by the PI or the appropriately qualified designee.
- •10. Subjects who have a positive urine drugs of abuse and alcohol screen (confirmed by repeat) at Screening or Admission or a positive alcohol breath test (confirmed by repeat) at Screening or Admission
- •11. Subjects who have serum hepatitis, are carriers of the hepatitis B surface antigen (HBsAg), are carriers of the hepatitis C antibody, or have a positive result for the test for human immunodeficiency virus (HIV) antibodies
- •12. 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 Admission
- •13. Subjects who have received any medications or substances (other than tobacco) which interfere with the cyclooxygenase pathway (e.g. anti-inflammatory drugs including aspirin and ibuprofen) within 14 days or 5 half-lives of the drug (whichever is longer) prior to Admission, or are known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days prior to Admission
- •14. Subjects who perform strenuous physical activity (exceeding the subject’s normal activity levels) within 7 days prior to Screening or Admission
- •15. Subjects who are unable to communicate effectively with the PI/study staff (i.e. language problem, poor
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