A Controlled, 3-arm Parallel Group Study to Demonstrate Reduction in Exposure to Smoke Constituents in Healthy Smokers Switching to THS 2.2 or to Smoking Abstinence, Compared to 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
- 166
- 试验地点
- 1
- 主要终点
- Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
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 consecutive days by adult Japanese healthy smokers affects the levels of biomarkers of exposure 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
- 23 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is Japanese.
- •Smoking, healthy subject as judged by the Investigator.
- •Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks, based on self reporting.
- •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).
- •The subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on CYP1A2 or CYP2A6 activity.
- •For women: Subject is pregnant or is breast feeding.
- •For women: Subject does not agree to use an acceptable method of effective contraception.
研究组 & 干预措施
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)
Smoking abstinence (SA)
Abstinence from smoking for 5 days in confinement
干预措施: Smoking abstinence (SA) (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 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 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 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