A Single-center, Randomized, Controlled, Partially Blinded, Crossover Study to Evaluate the Nicotine Pharmacokinetics and Pharmacodynamics of Two Variants of Vibrating Mesh 1.0 (VM 1.0), a Nicotine-containing Aerosol Generator, Compared to Cigarettes in Adult Current Smokers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Nicotine concentration
研究概览
简要总结
A single-center, randomized, controlled, partially blinded, crossover study to evaluate the pharmacokinetics and pharmacodynamics of nicotine following use of two variants of VM 1.0, VM16 and VM32, a nicotine-containing aerosol generator compared to cigarettes in adult current smokers. The participants will be blinded to the variants of VM 1.0 and to the randomized product use sequences. The study will be conducted with 3 periods and 3 sequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This is a partially blinded study: the participants will be blinded to the variants of VM 1.0 and to the randomized product use sequences. As part of the PMP quality control (QC) activity, a blinded data review will be performed before database lock. Data listings will be reviewed by the CRO and PMP, with no access to the product information for data review team members. Full details will be available in the data review plan.
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
- •Participant has signed the ICF and is able to understand the information provided in the ICF.
- •Male or female participant between 21 and 65 years inclusive.
- •Participant has smoked commercially available or roll-your own cigarettes (no brand restrictions) for at least the last 12 months prior to the Screening visit.
- •Participant has smoked at least 10 commercially available cigarettes per day in the past 30 days prior to the Screening visit and Admission.
- •Nicotine exposure status will be verified by urinary cotinine test (cotinine ≥ 200 ng/mL).
- •Participant has a BMI >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
- •Participant is available for the entire study period and willing to comply with study procedures, including product use assignments and periods of abstinence from any nicotine/tobacco containing products and willing to adhere to a standardized diet.
排除标准
- •Participant has reasons other than medical (e.g., psychological, social reason) not to be part of the study, as determined by the Principal Investigator or designee.
- •Participant is legally incompetent, or physically or mentally incapable of giving consent (e.g., emergency situation, under guardianship, prisoners).
- •Participant has a health condition which requires medication or any other clinically significant finding e.g., safety labs, pulmonary function test, vital signs, physical examination, ECG and medical history, as determined by the Principal Investigator or designee.
- •Participant experiences difficulty with venipuncture and/or poor venous access.
- •Participant has medical conditions which require, or will require during the study, a medical intervention (e.g., start of treatment, surgery, hospitalization).
- •Presence of fever (body temperature >37.5°C) e.g., a fever associated with a symptomatic viral or bacterial infection.
- •Participant has a hemoglobin level < 11.0 g/dL for females and < 12.0 g/dL for males at the Screening visit.
- •Participant uses medication that aids in smoking cessation.
- •Participant uses Tetrahydrocannabinol (THC)-containing products.
- •Participant previously attempted to quit using tobacco- or nicotine-containing products within 28 days prior to Admission.
- •Participant has donated plasma within seven days prior to screening or has donated or lost 450 mL or more of whole blood within 8 weeks prior to Screening for males, and in the 12 weeks prior to the Screening visit for females.
- •Participant has a positive serology test for HIV 1/2, hepatitis B or C.
- •Participant has a medical history of alcohol abuse within one year prior to Screening or regular use of alcohol within six months prior to the Screening visit that exceeds 10 units for women or 15 units for men of alcohol per week.
- •Participant has a positive urine drug test.
- •Participant has a positive alcohol breath test.
- •Participant or one of their family members is a current or former employee of the tobacco industry.
- •Participant or one of their family members is an employee of the investigational site or of any other parties involved in the study.
- •Participant has participated in another clinical study within 30 days prior to the Screening visit or concomitantly participates in any other investigational study.
- •Participant has been previously screened or enrolled in this study (except alternates)
- •For female participants only: participant has a positive urine pregnancy test at the Screening visit or at Admission or is a breastfeeding.
- •For females of childbearing potential only: participant does not agree to use an acceptable method of effective contraception.
结局指标
主要结局
Nicotine concentration
时间窗: From 5 minutes prior to product use to 12 hours after product use
To measure the observed plasma nicotine concentration \[C -5min\] and \[C 12hours\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.
Maximum nicotine concentration
时间窗: From 5 minutes prior to product use to 12 hours after product use
To measure the maximum observed plasma nicotine concentration \[Cmax\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.
Half-life of nicotine [t1/2]
时间窗: From 5 minutes prior to product use to 12 hours after product use
To measure half-life of nicotine \[t1/2\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.
Area under the observed plasma nicotine concentration-time curve (AUC)
时间窗: From 5 minutes prior to product use to 12 hours after product use
To measure the area under the observed plasma nicotine concentration-time curve (AUC) from the start the first puff (T0) to the timepoint of last quantifiable concentration \[AUC 0-last\] and extrapolated to infinity \[AUC 0-infinity\]
Time to the observed maximum concentration [Tmax]
时间窗: From 5 minutes prior to product use to 12 hours after product use
To measure the time to the observed maximum concentration \[Tmax\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.
Elimination rate constant [kel]
时间窗: From 5 minutes prior to product use to 12 hours after product use
To measure the elimination rate constant \[kel\]\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.
次要结局
未报告次要终点