A single-center, randomized, controlled, partially blinded, crossover study to evaluate the pharmacokinetics and pharmacodynamics of nicotine following use of two variants of VM 1.0, VM16 and VM32, a nicotine-containing aerosol generator compared to cigarettes in adult current smokers. The participants will be blinded to the variants of VM 1.0 and to the randomized product use sequences. The study will be conducted with 3 periods and 3 sequences.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
16
VM16 contains a liquid with a nicotine concentration of 1.6%
VM32 contains a liquid with a nicotine concentration of 3.2%
Subjects will provide their own usual brand of commercially available cigarettes
Celerion
Belfast, United Kingdom
Nicotine concentration
To measure the observed plasma nicotine concentration \[C -5min\] and \[C 12hours\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.
Time frame: From 5 minutes prior to product use to 12 hours after product use
Maximum nicotine concentration
To measure the maximum observed plasma nicotine concentration \[Cmax\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.
Time frame: From 5 minutes prior to product use to 12 hours after product use
Area under the observed plasma nicotine concentration-time curve (AUC)
To measure the area under the observed plasma nicotine concentration-time curve (AUC) from the start the first puff (T0) to the timepoint of last quantifiable concentration \[AUC 0-last\] and extrapolated to infinity \[AUC 0-infinity\]
Time frame: From 5 minutes prior to product use to 12 hours after product use
Time to the observed maximum concentration [Tmax]
To measure the time to the observed maximum concentration \[Tmax\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.
Time frame: From 5 minutes prior to product use to 12 hours after product use
Elimination rate constant [kel]
To measure the elimination rate constant \[kel\]\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.
Time frame: From 5 minutes prior to product use to 12 hours after product use
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Half-life of nicotine [t1/2]
To measure half-life of nicotine \[t1/2\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.
Time frame: From 5 minutes prior to product use to 12 hours after product use