A Randomized, Controlled, Open-label, 3-arm Parallel Group, Single-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Smoking, Healthy Subjects Switching to the Tobacco Heating System 2.2 (THS 2.2) or Smoking Abstinence, Compared to Continuing to Use Conventional Cigarettes, for 5 Days in Confinement.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
研究概览
简要总结
The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 days by adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 is Caucasian.
- •Current healthy smoker as judged by the Principal Investigator.
- •Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks.
- •Subject has smoked for at least the last 3 consecutive years.
- •Subject does not plan to quit smoking in the next 3 months.
排除标准
- •As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
- •Subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
- •Female subject is pregnant or breast feeding.
- •Female subject does not agree to use an acceptable method of effective contraception.
研究组 & 干预措施
Smoking abstinence (SA)
Abstinence from smoking for 5 days in confinement
干预措施: Smoking abstinence (SA) (Other)
Tobacco Heating System (THS 2.2)
Ad libitum use of THS 2.2 for 5 days in confinement
干预措施: Tobacco Heating System (THS 2.2) (Other)
Conventional cigarette (CC)
Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
干预措施: Conventional cigarette (CC) (Other)
结局指标
主要结局
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
时间窗: 5 days
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
时间窗: 5 days
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares (LS) means are provided as descriptive statistics.
Concentration of S-phenylmercapturic Acid (S-PMA)
时间窗: 5 days
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
Levels of Carboxyhemoglobin (COHb)
时间窗: 5 days
% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin. Geometric Least Squares means are provided as descriptive statistics.
次要结局
未报告次要终点