Pharmacokinetics Clinical Trial
Official title:
A Single-center, Open-label, Randomized, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile, Pharmacodynamics, Safety and Tolerability of Four P3P Variants in Smoking Healthy Adult Subjects
This is a single-center, open-label, randomized, crossover study to evaluate the pharmacokinetic (PK) profiles of four P3P variants (differing in nicotine aerosol particle size, nicotine concentration and in the absence or presence of a flavoring system), following a fixed puffing regimen and an ad libitum use period. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), as well as human puffing topography, will be evaluated, to provide further insights on product safety, acceptance, and use.
The goal of the proposed study is to evaluate the pharmacokinetic profiles of four P3P
variants. Variants with two different nicotine contents (1 mg/product and 2 mg/product), two
different nicotine aersol particle sizes and presence/absence of a flavoring system will be
tested to identify which one would yield plasma nicotine concentrations as close as possible
to those achieved after smoking a single cigarette. All of the subjects will initially use
the lowest nicotine content product (P3P 3). Subject will continue the study using the three
remaining products (P3P 1, P3P 2 and P3P 4) containing 2 mg nicotine/product in a randomly
assigned sequence.
Two product use regimens: fixed puffing and ad libitum use will be applied to provide insight
into nicotine absorption. The fixed puffing regimen with consistent use conditions across
subjects will be applied in order to minimize variability. The 1 hour ad libitum use period
will provide information on nicotine PK and product acceptance when subjects use the P3P
according to their own puffing behavior which is closer to a real-world setting.
Safety and tolerability will also be assessed throughout the study.
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