This is a single-center, open-label, concentration-ranging study to evaluate the nicotine PK profile and PD effects in healthy adult experienced users of closed tank/cartridge e-cigarettes using four different variants of P4M3 (nicotine concentration of 1.7%, 1.7% with 1.1% lactic acid \[LA\], 3% with 1.1% LA, and 4% with 2% LA) or their own e-cigarettes.
The goal of the study is to evaluate the nicotine concentration profiles and derived PK parameters, subjective effects, behavioral parameters, including puffing topography parameters of P4M3 with four different variants of P4M3, in experienced e-cigarette users after a single-use experience with fixed puffing regime and after ad libitum use of P4M3. Four variants of P4M3 will be evaluated together with subjects' own e-cigarettes to evaluate the relationship between the e-liquid composition (nicotine concentrations and presence of lactic acid) and the amount of nicotine absorbed, the speed of absorption, and the puffing topography.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
15
Subject's own e-cigarette
P4M3 e-liquid concentration of 1.7% nicotine without lactic acid
P4M3 e-liquid concentration of 1.7% nicotine with lactic acid
High Point Clinical Trials Center
High Point, North Carolina, United States
Plasma Nicotine Concentration Versus Time Profile
To measure total and background-corrected plasma nicotine concentration versus time profiles from 60 minutes of ad libitum use.
Time frame: From Day -1 (baseline) to Day 4
Peak Plasma Nicotine Concentration [cCpeak]
To measure background-corrected peak plasma nicotine concentration \[cCpeak\] from 60 minutes of ad libitum use.
Time frame: From Day -1 (baseline) to Day 4
Time to Peak Plasma Nicotine Concentration [Tpeak]
To measure the time to peak plasma nicotine concentration \[tpeak\] from 60 minutes of ad libitum use.
Time frame: From Day -1 (baseline) to Day 4
Background-corrected Trough Plasma Nicotine Concentration [cCtrough]
To measure background-corrected trough plasma nicotine concentration \[cCtrough\] from 60 minutes of ad libitum use.
Time frame: From Day -1 (baseline) to Day 4
Background-corrected Average of Plasma Nicotine Concentration [cCaverage]
To measure background-corrected average of plasma nicotine concentration between 0 to 1 hour \[cCaverage\] from 60 minutes of ad libitum use.
Time frame: From Day -1 (baseline) to Day 4
Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles
To measure the total and background-corrected plasma nicotine concentration versus time profiles of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.
Time frame: From Day -1 (baseline) to Day 4
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P4M3 e-liquid concentration of 3% nicotine with lactic acid
P4M3 e-liquid concentration of 4% nicotine with lactic acid
Background-corrected Maximum Plasma Concentration [cCmax]
To measure the background-corrected maximum plasma concentration \[cCmax\] of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.
Time frame: From Day -1 (baseline) to Day 4
Time to the Maximum Concentration [Tmax]
To measure the time to the maximum concentration \[tmax\] of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.
Time frame: From Day -1 (baseline) to Day 4
Background-corrected Area Under the Concentration-time Curve [cAUC(0-4h)]
To measure the background-corrected area under the concentration-time curve, which is above the corrected baseline from the start of product use to 4 hours \[cAUC(0-4h)\], of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.
Time frame: From Day -1 (baseline) to Day 4
Subjective Effects of P4M3 Use
Measured with an adapted version of the modified Cigarette Evaluation Questionnaire (adapted mCEQ) within 60 minutes after the ad libitum use session. Assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Time frame: From Day -1 (baseline) to Day 4
Area Under the Curve of Craving for an Electronic Cigarette
Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving), before and after the fixed puffing regimen and ad libitum use period. (The VAS craving was measured from 0 to 100 on a 100 mm scale.) The data below present the Area under the VAS craving score-time curve from the start of product use to 4 hours. The area under the curve for VAS craving is an integrated measurement of the VAS craving taking into account several timepoints. AUC was calculated using a trapezoidal rule between timepoints without normalization.
Time frame: From Day -1 (baseline) to Day 4
Sensory Parameters (Fixed Puffing Regimen)
Measured with a Sensory Questionnaire (SQ) within 60 minutes after each fixed puffing regimen use period. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Time frame: From Day 1 to Day 4
Sensory Parameters (ad Libitum Use)
Measured with a Sensory Questionnaire (SQ) within 60 minutes after each ad libitum use period. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Time frame: From Day 1 to Day 4
Human Puffing Topography (HPT) of the P4M3 Variants and the Subjects' Own E-cigarette
Total Puff Volume measured for the P4M3 variants and the subjects' own e-cigarette from the fixed puffing regimen and the 60 minutes ad libitum use.
Time frame: From Day -1 (baseline) to Day 4