A Randomized, Double-blinded, 2-arm Parallel Groups, Single Center Study to Assess Product Use and Adaptation, Safety and Tolerability of P3P, a Novel Nicotine-containing Product, in Adult Healthy Cigarette Smokers Switching to One of Two P3P Variants for One Month
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Plasma Nicotine Concentration-time Profile
研究概览
简要总结
The purpose of the study is to evaluate the product use and adaptation in adult, current cigarette smoking subjects between baseline and after one month of use of one of two P3P variants. The effect of P3P use behavior on nicotine pharmacokinetic (PK) profile, acceptability, as well as the safety and tolerability of P3P over a period of 1 month will be investigated.
详细描述
This is a study of daily use of up to 15 P3P products over one month, including 2 confinement periods (2 overnight stays at the beginning of the study and 1 overnight stay at the end of the exposure period). During the confinement visits, nicotine PK from P3P exposure will be assessed as well as pharmacodynamic effects related to craving, sensory parameters, product experience, and product acceptance.
Between the two confinement periods, subjects will return to the investigational site for weekly ambulatory visits during which P3P will be resupplied and selected safety and other study assessments will be performed.
From the start of the exposure period onwards, subjects will be instructed not to smoke or use other tobacco or nicotine containing products and to use P3P exclusively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Neither the site staff nor the subject will be informed about the product variant the subjects have been randomized to.
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 and dated the ICF and is able to understand the information provided in it.
- •Subject has been a smoker for at least the last 3 years prior to the Screening Visit and has smoked 5 to 15 commercially available cigarettes per day for the last 3 months prior to Screening.
- •Subject has a positive urinary cotinine test (cotinine ≥ 200 ng/mL).
- •Subject does not plan to quit smoking within 2 months.
- •Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.
- •Ready to switch from smoking cigarettes to using P3P for the duration of the study.
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 and/or social reason).
- •Subject has a clinically relevant disease which requires medication or any other clinically significant medical condition, which as per the judgment of the Investigator would jeopardize the safety of the subject.
- •Subject has asthma condition (post-bronchodilator FEV1/FVC < 0.75 and reversibility in FEV1 ≥ 12% and > 200 mL from pre- to post-bronchodilator values).
- •Subject has (FEV1/FVC) < 0.7 and FEV1 < 80% predicted value at post-bronchodilator spirometry.
- •Subject has a BMI < 18.5 kg/m2 or > 32.0 kg/m
- •Subject has received medication within 14 days or within 5 half-lives of the drug prior to Admission (whichever is longer) which has an impact on CYP2A6 activity.
- •Subject has a positive serology test for HIV 1/2, Hepatitis B, or Hepatitis C.
- •Subject has a positive alcohol breath test and/or a history of alcohol disorder within the past 2 years.
- •Subject has a positive urine drug test.
- •Subject has participated in another clinical study within 3 months prior to the Screening Visit.
- •Subject has been previously screened or enrolled in this study.
- •For women only: subject is pregnant or is breastfeeding.
- •For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.
研究组 & 干预措施
P3P-1mg
Subjects randomized to exclusive use of P3P-1mg
干预措施: P3P-1mg (Other)
P3P-2mg
Subjects randomized to exclusive use of P3P-2mg
干预措施: P3P-2mg (Other)
结局指标
主要结局
Plasma Nicotine Concentration-time Profile
时间窗: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.
To measure the plasma nicotine concentration-time profile following correction of baseline nicotine levels.
Maximum Nicotine Concentration [cCmax]
时间窗: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.
To measure the maximum plasma nicotine concentration \[cCmax\] following correction of baseline nicotine levels.
Time to the Maximum Nicotine Concentration [cTmax]
时间窗: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.
To measure the time to maximum nicotine concentration \[cTmax\] following correction of baseline nicotine levels.
Area Under the Concentration-time Curve From Start of Product Use (T0) to 4 Hours [cAUC(0-4h)]
时间窗: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.
To measure the area under the plasma concentration-time curve \[cAUC(0-4h)\] following correction of baseline nicotine levels.
次要结局
- Craving for a Cigarette(Before, during and up to 4 hours post-product use on day 1 and day 30)
- Product Dependence(Within 60 minutes after product use on day 1 and day 30.)
- Total NNAL(Measured at baseline, day 7, day 15, day 22, and day 29.)
- Product Experience(Within 60 minutes after product use on day 1 and day 30.)
- Product Acceptance(Within 60 minutes after product use on day 1 and day 30.)
- CEMA(Measured at baseline, day 7, day 15, day 22, and day 29.)
- Amount of Powder Extracted From P3P Used for PK Assessment.(Before and after product use, on day 1 and day 30.)
- NEQ(Measured at baseline, day 7, day 15, day 22, and day 29.)
- Sensory Parameters(Within 60 minutes after product use on day 1 and day 30.)
- Overall Product Use(Recorded daily by subject, in product use diary, from day 1 until day 30.)
- CYP2A6 Activity(Measured before product use, on day 1 and day 30.)
- Puffing Behavior of Subject(Evaluated by site staff on day 1 and day 30. Self-evaluated by subject on day 2, day 7, day 15, day 22, and day 29.)