ISRCTN38557348已完成未知
Assessing biomarkers of exposure in plasma and urine in current, daily users of nicotine pouches, tobacco-based snus, or combustible cigarettes, or nonusers of tobacco/nicotine products.
Swedish Match North Europe0 个研究点目标入组 198 人开始时间: 2022年12月5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
- 198
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Other
入排标准
- 性别
- All
入选标准
- •1. Willing and able to give written informed consent for participation in the study.
- •2. Healthy male or female subject aged =25 to =45 years.
- •3. Clinically normal medical history, physical findings, vital signs, ECG, lung function assessment/spirometry and laboratory values at the time of screening, as judged by the investigator.
- •4. No exposure to passive smoking (from living with someone who smokes at home) may occur in any of the study groups, except for the users of combustible cigarettes.
- •5. Women of child-bearing potential (WOCBP) must be willing to use a sufficient contraceptive method for the duration of the study, this includes mechanical barrier (e.g., a male condom or a female diaphragm), combined [estrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal anticonception associated with inhibition of ovulation [oral, injectable, implantable], intra uterine device or intra uterine system. Sexual abstinence is allowed when this is the preferred and usual lifestyle of the subject.
- •Additional inclusion criteria for Group A (Users of Swedish Match brand nicotine pouch products):
- •1. Exclusive user of a Swedish Match brand nicotine pouch product, with a nicotine content between 3 and 16 mg per pouch, for =1 year, with a minimum daily consumption of 4 or more pouches, prior to screening.
- •2. Used <100 units of combustible cigarette products during their lifetime, with no usage during the last 1 year.
- •3. Urinary cotinine levels =200 ng/mL on Visit 1.
- •4. Willingness to use only one specific Swedish Match brand nicotine pouch (type, flavor, and nicotine strength) product during the conduct of this study (total of 14 days).
- •Additional Inclusion Criteria for Group B (Users of tobacco-based snus products):
- •1. Exclusive user of a Swedish tobacco-based snus product, with a nicotine content between 4 and 20 mg per pouch, for =1 year, with a minimum daily consumption of 4 or more pouches, prior to screening.
- •2. Used <100 units of combustible cigarette products during their lifetime, with no usage during the last 1 year.
- •3. Urinary cotinine levels =200 ng/mL on Visit 1.
- •4. Willingness to use only one specific tobacco-based snus product (brand, type, flavor, and nicotine strength) during the conduct of this study (total of 14 days).
- •Additional Inclusion Criteria for Group C (Users of combustible cigarettes):
- •1. Exclusive user of a commercially manufactured combustible cigarette product, for =1 year, with a minimum daily consumption of 4 or more combustible cigarettes, prior to screening.
- •2. Urinary cotinine levels =200 ng/mL on Visit 1.
- •3. Willingness to use only one specific commercially manufactured combustible cigarette product (brand, type, flavor, and nicotine strength) during the conduct of this study (total of 14 days).
- •Additional Inclusion Criteria for Group D (Nonusers):
- •1. Nonusers of tobacco/nicotine products who have used <100 units of tobacco/nicotine products during their lifetime, with no usage during the last 1 year.
- •2. Urinary cotinine levels <200 ng/mL on Visit 1.
排除标准
- •1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.
- •2. A history of diagnosed hypertension or any cardiovascular disease (CVD), or chronic respiratory disease like asthma, chronic obstructive pulmonary diseases, chronic bronchitis, or ongoing manifestations of hypertension or any CVD or chronic respiratory disease as judged by the Investigator.
- •3. Any surgical or medical condition, including abnormal salivation (also pharmaceutically induced), or history thereof, which, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism or excretion of the nicotine products or may either put the subject at risk because of participation in the study, influence the results, or the subject’s ability to participate in the study.
- •4. Subjects who are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- •5. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
- •6. A history of diagnosed severe allergy/hypersensitivity or ongoing manifestations of severe allergy/hypersensitivity to aroma compounds (including fragrances and/or flavorings), as judged by the Investigator.
- •7. Positive screen for drugs of abuse or alcohol at screening or on the study visits. Positive results that are expected given the subject’s medical history and prescribed medications can be disregarded as judged by the Investigator.
- •8. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse, as judged by the Investigator.
- •9. BMI =18 and =33 kg/m².
- •10. Regular use of any medication, especially those which may interfere with the cyclooxygenase pathway (e.g., anti-inflammatory drugs including aspirin and ibuprofen) or drugs known to be strong inducers/inhibitors of CYP450 enzymes within 14 days prior to screening or during the study; use of hormonal contraceptives (females) and nonprescription pain medication [paracetamol] are permitted.
- •11. Subjects who intend to change their nicotine consumption habit, including the intention to stop using nicotine products, within the next 3 months of the screening visit, as judged by the Investigator.
- •12. The Investigator considers the subject unlikely to comply with study procedures, restrictions, and requirements.
- •13. Planned treatment or treatment with an investigational drug within 3 months prior to Visit 2. Subjects consented and screened but not dosed in previous Phase I studies are not to be excluded.
- •Additional Exclusion Criteria for users of nicotine pouches (Group A):
- •1. Use of other tobacco/nicotine products, including any other Swedish Match brand or other brand of nicotine pouch products, instead of or in addition to the Swedish Match nicotine pouch product used at the study start.
- •2. No use of the product for one or more days during the study.
- •3. Exposure to passive smoking in the household.
- •Additional Exclusion Criteria for users of tobacco-based snus (Group B):
- •1. Use of any other tobacco/nicotine products, including any other tobacco-based snus product instead of or in addition to the tobacco-based snus product used at study start.
- •2. No use of the product for one or more days during the study.
- •3. Exposure to passive smoking in the househ
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