A Randomized, Controlled, Open-label, 2-arm Parallel Group, Single Center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Healthy Smokers Switching to the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) Compared to Continuing to Use Conventional Cigarettes During 5 Days in Confinement.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Levels of Carboxyhemoglobin (COHb)
研究概览
简要总结
The overall goal of the study is to demonstrate the reduction of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in adult smokers switching for 5 days from conventional cigarette (CC) to Carbon Heated Tobacco Product 1.0 (CHTP 1.0) as compared to smokers continuing to use CC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is aged ≥ 21 years.
- •Subject is Caucasian.
- •Subject is healthy, as judged by the Investigator.
- •Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for at least the last 6 weeks prior to admission, based on self-reporting.
- •Subject has smoked at least for the last 3 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.
结局指标
主要结局
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.
Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
时间窗: 5 days
Concentrations measured on 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 on 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 on Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
次要结局
未报告次要终点