A Single-center, Randomized, Controlled, Open-label Study in Smoking Healthy Subjects to Investigate the Nicotine Pharmacokinetic Profiles Following Single Use of Tobacco Heating System (THS) With a Regular or a Menthol Stick, Compared to Smoking of a Single Combustible Cigarette (CIG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Maximum Plasma Concentration [Cmax]
研究概览
简要总结
The purpose of this study was to describe the nicotine pharmacokinetic (PK) profile during and after single use of THS (Induction heating technology, with either a regular or menthol stick) compared to singular CIG smoking in healthy adult subjects. In addition, pharmacodynamic effects (subjective effects) were evaluated to provide further insights on product acceptance and likelihood to use the THS again. Safety was assessed throughout the study.
详细描述
General information about the research:
Study Title:
Nicotine Pharmacokinetics of THS Single Use of a Regular or a Menthol Stick Compared to CIG
Who carried out the research? This research was sponsored and funded by Philip Morris Products S.A.
What public involvement there was in the study? Thirty-one healthy, currently smoking, adults participated in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has signed the ICF and is able to understand the information provided in the ICF.
- •Subject has been a smoker for ≥3 years prior to the screening visit (smoking cessation attempts during this period, if any, did not last > 6 months in total).
- •Subject has continuously smoked on average ≥10 commercially available regular CIG/day over the last 4 weeks. Smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL).
- •Subject is healthy as judged by the Investigator based on available assessments from the screening period (e.g., safety laboratory, spirometry, vital signs, physical examination, ECG, and medical history).
- •Subject does not plan to quit smoking within the next three months.
排除标准
- •As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical (e.g., psychological, social reason).
- •Subject is legally incompetent, or physically or mentally incapable of giving consent (e.g., in emergency situations, under guardianship, prisoners).
- •Subject has a clinically relevant disease which requires medication (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, urological, immunological, pulmonary, and cardiovascular disease) or any other medical condition (including safety laboratory), which as per the judgment of the Investigator would jeopardize the safety of the subject.
- •Subject experienced within 30 days prior to screening/admission a body temperature >37.5°C or an acute illness (e.g., upper respiratory-tract infection, viral infection, etc.) or the subject has a confirmed or suspected active COVID-19 infection (based on the signs and symptoms observed at the time of assessment)
- •As per the Investigator's judgment, the subject has medical conditions which do or will require a medical intervention (e.g., start of treatment, surgery, hospitalization) during the study participation, which may interfere with the study participation and/or study results.
- •Subject has relevant history of, or current asthma condition or COPD condition, and/or clinically significant findings.
- •Subject has donated blood or received whole blood or blood products within 3 months.
- •BMI < 18.5 kg/m2 or ≥ 32.0 kg/m
- •Positive serology test for HIV 1/2, HBV, or HCV.
- •Subject has a positive alcohol breath test and/or has a history of alcohol disorder that could interfere with their participation in the study.
- •The subject has a positive urine drug test.
- •Subject or one of their family members is a current or former employee of the tobacco or e-cigarette industry.
- •Subject or one of their family members is an employee of the investigational site or of any other parties involved in the study.
- •Subject has participated in another clinical study within 3 months.
- •Subject has been previously screened or enrolled in this study.
- •Subject is pregnant (does not have negative pregnancy tests at Screening and at Baseline) or is breastfeeding.
- •For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.
结局指标
主要结局
Maximum Plasma Concentration [Cmax]
时间窗: Measured from start of product use to 24 hours
To measure Cmax from the single use of THS with either a regular or a menthol stick or of a single cigarette.
Time to the Maximum Concentration [Tmax]
时间窗: Measured from start of product use to 24 hours
To measure Tmax from the single use of THS with either a regular or a menthol stick or of a single cigarette.
Area Under the Curve of Nicotine Plasma Concentration-time Computed From T0 to T=24 Hours [AUC0-24h]
时间窗: Measured from start of product use to 24 hours
To measure AUC0-24h from the single use of THS with either a regular or a menthol stick or of a single cigarette.
Area Under the Curve of Nicotine Plasma Concentration-time Computed From T0 to the Subject-specific Time of Maximum Nicotine Concentration [AUC0-t']
时间窗: Measured from start of product use to 24 hours
To measure the area under the curve of nicotine plasma concentration-time computed from T0 to the subject-specific time of maximum nicotine concentration \[AUC0-t'\], from the single use of THS with either a regular or a menthol stick or from a single cigarette. (AUC0-Tmax)
次要结局
未报告次要终点