ISRCTN13625876进行中（未招募）Unknown
A randomised, controlled, single-centre, open-label study to assess elements of abuse liability and nicotine pharmacokinetics for a glo heating device with two variants of an alternative non-tobacco, nicotine-containing consumable in healthy adult heated tobacco product users
British American Tobacco (United Kingdom)0 个研究点目标入组 36 人开始时间: 2024年5月16日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
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. Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in Italian or English.
- •2. Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent.
- •3. Subjects who have a
- •3.1. body mass index (BMI) of 18.5 to 30.0 kg/m², inclusive.
- •3.2. body weight exceeding 52 kg (males) or 45 kg (females).
- •4. Uses HTP daily and consumes an average of at least 5 HTP sticks per day.
- •5. Smokes combustible, filtered, factory-made cigarettes, 83 mm to 100 mm in length.
- •6. Smokes an average of at least 20 cigarettes per week and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 1830 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the PI.
- •7. Agrees to use the same UB HTP and/or smoke the same UB cigarette throughout the study period. The UB HTP or UB cigarette is defined as the reported HTP brand currently used or cigarette brand style currently smoked most frequently, respectively, by the subject.
- •NOTE: HTP users or combustible cigarette smokers who also use other tobacco- or nicotine-containing products (e.g., electronic cigarettes, smokeless tobacco, and modern oral nicotine products) on no more than one day per week will not be excluded from study participation.
- •8. Expired breath carbon monoxide (ECO) level is = 7 ppm and = 100 ppm at Screening and at check-in on Day 1.
- •9. Positive (=200 ng/ml) urine cotinine test at Screening.
- •10. Willing to use UB HTP, UB cigarette, HTP/HHP IPs, and nicotine gum during the study period.
- •11. Willing to abstain from tobacco and nicotine use for at least 12 hours prior to the start of each Test Session.
- •12. Females must be willing to use a form of contraception acceptable to the PI from the time of signing the informed consent until End-of-Study.
- •13. Males must use an acceptable method of birth control from Day 1 check-in” until the end of the study, unless they have had a vasectomy or are abstinent from heterosexual intercourse, or their female partner is not able to bear children.
- •14. Agrees to an in-clinic confinement of 6 days (5 nights).
排除标准
- •1. Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study subject unsuitable to participate in this clinical study.
- •2. History, presence of, or clinical laboratory test results indicating diabetes. History of gestational diabetes which is no longer present nor indicated by clinical laboratory test results is acceptable.
- •3. Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit.
- •4. History or presence of bleeding or clotting disorders.
- •5. Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
- •6. Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes at Screening and at check-in on Day 1.
- •7. Hemoglobin level is < 12.5 g/dL for females or < 13.0 for males g/dL at Screening.
- •8. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- •9. A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or check-in on Day 1.
- •10. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- •11. Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (=) 30 days prior to signing the ICF.
- •12. Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous attempt within (=) 1830 days prior to signing the ICF.
- •13. Any use of aspirin (= 325 mg/day) or anticoagulants.
- •14. Individuals = 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
- •15. Whole blood donation within 8 weeks (= 56 days) prior to signing the ICF.
- •NOTE: Subjects will be advised against scheduling a whole blood donation for at least 7 days following study completion.
- •16. Plasma donation within (=) 7 days prior to signing the ICF.
- •NOTE: Subjects will be advised against scheduling a plasma donation for at least 7 days following study completion.
- •17. Employed by a tobacco or nicotine manufacturer, distributor or retailercompany, the study site, or handles tobacco- or nicotine-containing products as part of their job.
- •18. Participation in another clinical trial within (=) 180 days prior to signing the informed consent. The 180-day window for each subject will be derived from the date of the last study event in the previous study to the time of signing the ICF in the current study.
- •19. Has a significant history of alcoholism or drug abuse within 24 months prior to Screening, as determined by the PI, or has a positive breath alcohol test at Screening or check-in on Day 1.
- •20. Determined by the PI to be inappropriate for this study.
研究者
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