CSD201202: A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System P12
Condition: Smoking; Tobacco Use
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): ENDS Product A with 1.5% nicotine; ENDS Product B with 1.5% nicotine; ENDS Product C with 1.5% nicotine; ENDS Product D with 1.5% nicotine; ENDS Product E with 1.5% nicotine; ENDS Product F with 1.5% nicotine; ENDS Product G with 1.5% nicotine; ENDS Product H with 1.5% nicotine
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): P1211216, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine; P1213516, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine; P1213416, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine; P1212716, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine; P1213716, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine; P1213816, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine; P1211916, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine; P1210016, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other