NCT03463837已完成不适用
A Randomized, Open-Label, Parallel-Group Study to Characterize Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in primary biomarkers day 5 values for each JUUL 5% product will be compared to baseline:
研究概览
简要总结
The JUUL 5% Electronic Nicotine Delivery System (ENDS) is being studied as an alternative to combustible cigarette use. This study aims to find out how much nicotine is in the blood and urine of healthy adult subjects after using three JUUL 5% ENDS compared to smoking usual brands of combustible cigarettes and stopping smoking.
详细描述
This study will serve as a clinical evaluation of the exclusive use of selected JUUL ENDS, with the purpose of gaining an understanding of toxicant exposure.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male or female smoker, 21 to 65 years of age.
- •Has been a smoker for at least 12 months prior to Screening.
- •Currently smokes an average of 10 cigarettes each day.
- •Has a positive urine cotinine (≥ 500 ng/mL).
- •Has an exhaled carbon monoxide (CO) > 12 ppm.
- •A female subject of childbearing potential must have been using contraception and agree to continue using it through completion of the study:
- •Provides voluntary consent to participate in this study documented on the signed informed consent form (ICF).
- •Key Exclusion Criteria
- •Has a history or presence of clinically significant conditions.
- •Has a body mass index (BMI) > 40 kg/m2 or < 18 kg/m2 at Screen
- •Has a history of drug or alcohol abuse
- •Has an estimated creatinine clearance < 80 mL/minute
- •If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study.
- •Has used nicotine-containing products other than manufactured cigarettes within 14days of screening.
- •Is planning to quit smoking during the study, planning to quit within 3 months following Day 1
排除标准
- 未提供
结局指标
主要结局
Change in primary biomarkers day 5 values for each JUUL 5% product will be compared to baseline:
时间窗: [Time Frame: 5 days]
Change in ; Urine N nitrosonornicotine (NNN), 4 (methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), 3 hydroxypropylmercapturic acid (3-HPMA), monohydroxybutenylmercapturic acid (MHBMA), and S-phenyl mercapturic acid (S-PMA) "Blood carboxyhemoglobin (COHb)
次要结局
- Change of area under the curve (AUC) Plasma PK of Nicotine([Time Frame: Day 7,)
- Change in concentration of Glucuronides in urine([Time Frame: 5 days])
- Change in maximum concentration (Cmax) Plasma pharmacokinetic (PK) of Nicotine([Time Frame: Day 7,)
- Change in concentration of 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine([Time Frame: 5 days])
- Change in concentration of 2-cyanoethyl-mercapturic acid (CEMA) in urine([Time Frame: 5 days])
- Change in concentration of trans-3'-hydroxycotinine in urine([Time Frame: 5 days])
- Change in concentration of Nicotine in urine([Time Frame: 5 days])
- Change in concentration of Cotinine in urine([Time Frame: 5 days])
- Change in concentration of Cotinine in blood([Time Frame: 5 days])
- Change in concentration of 1-hydroxypyrene (1-OHP) in urine([Time Frame: 5 days])
- Change in concentration of Nicotine in blood([Time Frame: 5 days])
- Change in time to maximum concentration (Tmax) Plasma PK of Nicotine([Time Frame: Day 7,)
- Measure of future intent to use JUUL 5% Device device relative to usual combustible cigarette and smoking cessation.([Time Frame: 6-7 days, intervention dependent])
- Change in concentration of trans-3'-hydroxycotinine in blood([Time Frame: 5 days)
- Incidence of JUUL 5% Device, including malfunction and/or misuse([Time Frame: 7 days])
- Product use over 5-day period and during 5-minute fixed and ad libitum use episodes([Time Frame: 7 days])
- Measure of subjective Smoking Urge Assessment([Time Frame: 6-7 days, intervention dependent])
- Measure of subjective product evaluation using the "modified Product Evaluation Scale (mPES)"([Time Frame: 6-7 days, intervention dependent])
- Number of participants with Adverse Events associated with use of JUUL 5% Device to combustible cigarette and smoking cessation([Time Frame: 13-14 days, intervention dependent])
研究者
研究点 (2)
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