A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of THS 2.2 Following Single Use in Healthy Smokers Compared to Conventional Cigarettes and Nicotine Gum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NRT
研究概览
简要总结
The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the amount of nicotine absorbed) following a single use of the THS 2.2, a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a cigarette (CC) and from a single use of nicotine gum in a Japanese population.
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
- 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 CCs per day (no brand restrictions) for the last 4 weeks.
- •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 a drug (whichever is longer) which has an impact on 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
THS 2.2 then CC
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of THS 2.2)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of CC).
干预措施: CC (Other)
THS 2.2 then CC
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of THS 2.2)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of CC).
干预措施: THS 2.2 (Other)
CC then THS 2.2
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of CC)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of THS 2.2).
干预措施: THS 2.2 (Other)
THS 2.2 then NRT
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of THS 2.2)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single administration of NRT gum [Nicorette® 2mg]).
干预措施: THS 2.2 (Other)
THS 2.2 then NRT
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of THS 2.2)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single administration of NRT gum [Nicorette® 2mg]).
干预措施: NRT Gum (Other)
NRT then THS 2.2
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single administration of NRT gum [Nicorette® 2mg])
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of THS 2.2).
干预措施: THS 2.2 (Other)
NRT then THS 2.2
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single administration of NRT gum [Nicorette® 2mg])
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of THS 2.2).
干预措施: NRT Gum (Other)
CC then THS 2.2
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of CC)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of THS 2.2).
干预措施: CC (Other)
结局指标
主要结局
Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NRT
时间窗: Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0
T0 = start of single product use. Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use). Geometric Least Squares means are provided.
Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NRT
时间窗: Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0
T0 = start of single product use. Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use). Geometric Least Squares means are provided.
次要结局
未报告次要终点