Study procedures
urine/breath alcohol
ADVERSE EVENTS, CAVITY
This study was a randomised, open label, crossover, confinement study in 24 male and female cigarette smokers. The study assessed 3 test products and a cigarette comparator and evaluated nicotine pharmacokinetics, subjective effects, puff topography and product safety. An overview of the study design is presented in Fig. Study design overview.At Visit 1 (screening), which took place within 27 days prior to study procedures on Day −1, subjects underwent numerous assessments to check their eligibility to participate in the study, to review their health status, and to assess their nicotine consumption habits. Screening procedures included a physical examination (including oral cavity and oropharynx), vital signs, electrocardiogram, body mass index (BMI), clinical laboratory tests (hematology, serum chemistry, and urinalysis), serology, urine/saliva drug, urine/breath alcohol, cotinine screen, eCO, and pregnancy and FSH tests (for females as appropriate). If requested, subjects were offered smoking cessation advice and contact information for a smoking cessation support service.Visit 2 was a 5-day confinement period; subjects who successfully completed the screening procedures and met all the inclusion criteria and none of the exclusion criteria were eligible to check in to the clinical site for the confinement period. Subjects checked into the clinic on Day −1 and remained at the clinic until Day 4 for daily study product use, nicotine pharmacokinetics sampling, subjective questionnaire assessments, puff topography evaluation, and safety assessments. On Day −1, following eligibility confirmation, subjects undertook a familiarisation session with the study HTPs and the questionnaires. The site’s clinical team explained how the Pulze HTS was to be used. Subjects had the opportunity to see the products/devices and packaging and participated in a product trial in which they consumed one iD stickOn Days 1 through 4, following the 4-h pharmacokinetic blood collection, subjects started a 4-h ad libitum product use session (no limits on cigarette or HTP consumption) with the same study product as that used during the morning controlled use session. Puff topography assessments were also made in the study but are not reported in this manuscript, and no blood samples were taken in this period for nicotine pharmacokinetic analyses. After completion of the ad libitum use session, subjects were allowed to smoke their own cigarettes ad libitum until at least 12 h prior to the start of the morning controlled product use session scheduled on the following day. On Day 4, following completion of study assessments, subjects were allowed to smoke their own cigarettes and left the clinic after completing all final check-out requirements.A follow-up telephone call (Visit 3) was made by the clinic in an attempt to contact all subjects who used at least one study product (including subjects who terminated the study early) using their standard procedures approximately 7 days after the final product use to determine if any adverse events (AEs) had occurred since the last study visit.