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This is an open-label, randomized, 8-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS.
Full description
This study is designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following the use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS.
Potential subjects will complete a pre-screening interview and a Screening Visit to assess eligibility within 45 days prior to enrollment, randomization and confinement.
Following the Screening Visit, eligible subjects will be scheduled for a check-in and randomization visit. At the check-in and randomization visit, subjects' continued eligibility will be confirmed prior to being randomized to a product use sequence and beginning 9 nights and 10 days of confinement.
Starting on study Day 1, subjects will start a Pre-study ENDS IP Acclimation Period. During Pre-Study Product Acclimation Period, subjects will be required to acclimate to each of the ENDS IP at least once, while having access to their usual brand (UB) cigarettes for ad libitum use. Starting on Day 3, subjects will participate in eight separate Test Sessions for nicotine PK assessment, one for each ENDS IP. For approximately a half day prior to each respective Test Session (starting on Day 2), subjects will use the assigned ENDS IP for the following day's Test Session at least four times.
Starting on Day 3 and continuing through Day 10, subjects will participate in eight separate Test Sessions, one for each IP that will last for approximately 4 hours following the start of 5 minutes of ad libitum IP use. During each Test Session, subjects will use one of the eight IPs. The ENDS IP for each Test Session will be determined based on a randomly assigned ENDS IP presentation schedule, where an 8-sequence ENDS IP use schedule will be generated using a Williams Design. Each Test Session will be preceded by a 12-hour tobacco/nicotine product abstention the night before.
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Inclusion criteria
Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of consent.
Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
Positive urine cotinine test at Screening.
Smokes only combustible filtered, menthol or non-menthol combustible cigarettes (CC), 83 mm to 100 mm in length.
Agrees to smoke same usual brand (UB) cigarette throughout the study period. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the subject.
Subjects must meet one (a or b) of the following tobacco use conditions:
i. Smoking at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to screening due to illness, quit attempt or clinical study participation will be allowed at the discretion of the Investigator and ii. Using a nicotine-containing electronic nicotine delivery system (ENDS) (cartridge or a tank system).
Willing to use only UB cigarette and ENDS during the study period.
Willing to abstain from tobacco and nicotine use for at least 12 hours prior to each Test Session.
Females must be willing to use a form of contraception acceptable to the PI from the time of signing informed consent until End-of-Study.
Agrees to in-clinic confinement of 10 days and 9 nights.
Exclusion criteria
Primary purpose
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36 participants in 8 patient groups
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Data sourced from clinicaltrials.gov
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