NCT03369340

Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
OTHER	P3P 1	2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
OTHER	P3P 2	2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
OTHER	P3P 3	1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
OTHER	P3P 4	2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm

Timeline

• Start date: 2017-11-07
• Primary completion: 2018-02-01
• Completion: 2018-05-02
• First posted: 2017-12-12
• Last updated: 2020-01-31
• Results posted: 2020-01-31

Locations

1 site across 1 country: Switzerland