NCT05383508

Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes

A Single-center, Randomized, Controlled, Open-label, Cross-over Study in Healthy Subjects to Investigate the Nicotine Pharmacokinetic Profiles of 2 Variants of P4M3 Gen 2.0, an Electronic Nicotine Delivery System, Compared to Cigarettes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 24 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, controlled, open-label, cross-over study with healthy adult smokers. The study will investigate the nicotine pharmacokinetic (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette, compared to smoking combustible cigarettes. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), will be evaluated to provide further insights on product evaluation, craving, liking, puffing topography. The study will be conducted with three periods and six sequences in a cross-over design. This study is exploratory and there is no pre-specified hypothesis to be tested.

Detailed description

The purpose of the study is to evaluate the nicotine pharmacokinetics (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette versus cigarettes following a six minutes ad libitum use period. In addition, pharmacodynamic effects (PD), including subjective effects and related behavioral assessments, as well as human puffing topography (HPT) will be evaluated, to provide further insights on P4M3 Gen 2.0 product acceptance and product use. Safety will be assessed throughout the study. The aim is to evaluate if P4M3 Gen 2.0 can provide an acceptable alternative to smoking cigarettes in terms of both, nicotine delivery and sensorial satisfaction for current adult smokers who would otherwise continue smoking cigarettes.

Conditions

• Nicotine Vaping
• Nicotine
• Vaping

Interventions

Type	Name	Description
OTHER	CA35	Nicotine concentration: 3.5 % e-liquid flavor: Tobacco
OTHER	CM35	Nicotine concentration: 3.5 % e-liquid flavor: Menthol
OTHER	Cig	Subjects' preferred brand of commercially available, regular or mentholated cigarettes

Timeline

• Start date: 2022-04-28
• Primary completion: 2022-06-29
• Completion: 2022-08-25
• First posted: 2022-05-20
• Last updated: 2024-04-26
• Results posted: 2024-04-26

Locations

1 site across 1 country: United States