BAT3221032: A Study to Evaluate the Effects of Switching From Cigarette Smoking to Using One of Five Variants of a Heated Tobacco Product on Biomarkers of Exposure and Biomarkers of Potential Harm in Healthy Subjects
Condition: Smoking; Tobacco Use; Tobacco Smoking
Study type: Interventional

Summary: 
      This is a randomized, controlled, multi-center, open-label, 8-cohort parallel group study to
      assess changes in select biomarkers of exposure (BoE) and biomarkers of potential harm (BoPH)
      in generally healthy smokers switching to the study investigational products (IPs), compared
      to subjects who continue to smoke, undergo smoking abstinence, or have never smoked.
    

Detailed description: 
      All subjects will participate in a baseline biomarker assessment and smokers will then be
      switched to exclusive use of their assigned product (cohorts 1-5), continue to smoke (cohort
      6), or smoking cessation (cohort 7), and never-smokers will continue to not smoke (cohort 8).
      Subjects will be directed to use their assigned product exclusively for 3 months and will
      participate in study visits throughout the study for safety, product re-supply and collection
      of samples for biomarker assessments. Throughout the study, subjects will report their daily
      use of the study IP and/or cigarette smoking.

      This study will be ambulatory, with subjects in cohorts 1-7 attending a total of 4 clinic
      visits (one every approximately 30 days) over a period of 3 months. Subjects in cohorts 1-7
      will be confined in the study site overnight the night before their Day 1 (Visit 1, baseline)
      and Day 90 (Visit 4) visits. The Day 30 (Visit 2) and Day 60 (Visit 3) visits will be
      non-residential visits for pregnancy testing (female subjects) and product usage assessments
      and resupply only. Subjects in cohort 8 will attend the clinic for Visit 1 and Visit 4 only,
      and will be confined in the clinic overnight the night before each of these visits. In
      addition, all subjects will attend a Screening Visit.

      Smokers will be asked to continue smoking their usual brand (UB) cigarettes until
      randomization (cohorts 1-6) or enrollment (cohort 7) at Visit 1. Never-smokers will be asked
      to continue not to use any tobacco or nicotine products for the entire study duration.

      All subjects will be confined on Visit 1 and will use their UB cigarettes ad libitum during
      this period (unless required to abstain for specific tests and excluding cohort 8, who will
      not use any nicotine or tobacco products). Exhaled breath, 24-hour urine and blood samples
      will be collected and evaluated for baseline BoE and BoPH. Smokers of non-menthol UB
      cigarettes will then be randomized to cohort 1, 5 or 6; smokers of mentholated UB cigarettes
      will be randomized to cohort 2, 3, 4 or 6; smokers who intend to quit smoking will be
      enrolled to cohort 7; and never-smokers will be enrolled to cohort 8.

      All subjects will be confined on Visit 4. Subjects in cohorts 1-6 will use their assigned
      product exclusively, ad libitum during this period (unless required to abstain for specific
      tests). Other than subjects in cohort 7 who are using nicotine replacement therapy as part of
      their smoking cessation strategy, subjects in cohorts 7 and 8 will not use any tobacco or
      nicotine products. Exhaled breath, 24-hour urine and blood samples will be collected and
      evaluated for BoE and BoPH.
    

Intervention name(s): Product A: Non-Combusted Cigarette Variant 42001402 and product use Mode B; Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode B; Product C: Non-Combusted Cigarette Variant 42001401 and product use Mode B; Product D: Non-Combusted Cigarette Variant 40007386 and product use Mode B; Product E: Non-Combusted Cigarette Variant 42001402 and product use Mode A
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): 42001402, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B; 42001399, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B; 42001401, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B; 40007386, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B; 42001402, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other