ISRCTN16988167已完成未知
A cross-sectional study to assess biomarkers of exposure and biomarkers of potential harm in solus users of Lyft nicotine pouch products
British American Tobacco (United Kingdom)0 个研究点目标入组 220 人开始时间: 2021年3月17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
- 220
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36201395/ (added 25/11/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36484137/ (added 12/12/2022)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Subjects will be required to satisfy all of the following criteria at Screening, unless otherwise stated:
- •All subjects:
- •1. Subjects will be:
- •1.1. Healthy adult 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 Investigator or the appropriately qualified designee based on:
- •3.1. Medical history (confirmed by volunteer)
- •3.2. Physical examination
- •3.3. Vital signs assessment: Supine systolic and diastolic blood pressure, supine pulse rate, respiratory rate and tympanic body temperature
- •3.4. 12-lead ECG
- •3.5. Clinical laboratory evaluations
- •3.6. Lung function tests/spirometry
- •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 ICF, be able to communicate well with the Investigator 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 Investigator or the appropriately qualified designee.
- •6. Subjects will refrain from consuming alcohol within 24 hours prior to Screening and Admission.
- •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 and Admission.
排除标准
- •Subjects will be excluded from participation in the study if they satisfy any of the following criteria at Screening, unless otherwise stated:
- •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 or medical investigation within 4 weeks prior to screening as judged by the Investigator.
- •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 Investigator or the appropriately qualified designee.
- •5. Subjects who have a positive urine drugs of abuse or breath alcohol screen (confirmed by repeat) at Screening or Admission.
- •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-19 test at Screening or Admission indicating current, active infection , or not providing proof of a negative COVID-19 test taken within 248 hours of Screening (Denmark only).
- •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 not approved by the Investigator during the period beginning with screening and ending with discharge (for female subjects, hormonal contraceptives are acceptable, and for all subjects, painkillers [paracetamol] are permitted).
- •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 Investigator 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, cardiovascul
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