NCT03379740

Study to Investigate the Nicotine Pharmacokinetic Profiles and Pharmacodynamic Effects of P4M3 Variants

A Single-center, Open-label, Concentration-ranging Study to Investigate the Nicotine Pharmacokinetic Profiles and Pharmacodynamic Effects of the P4M3 Variants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (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, 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.

Detailed description

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.

Conditions

• Vaping
• Nicotine Absorption

Interventions

Type	Name	Description
OTHER	E-cigarette	Subject's own e-cigarette
OTHER	P4M3-1.7%	P4M3 e-liquid concentration of 1.7% nicotine without lactic acid
OTHER	P4M3-1.7%LA	P4M3 e-liquid concentration of 1.7% nicotine with lactic acid
OTHER	P4M3-3%LA	P4M3 e-liquid concentration of 3% nicotine with lactic acid
OTHER	P4M3-4%LA	P4M3 e-liquid concentration of 4% nicotine with lactic acid

Timeline

• Start date: 2017-07-11
• Primary completion: 2017-08-14
• Completion: 2017-12-01
• First posted: 2017-12-20
• Last updated: 2019-11-22
• Results posted: 2019-11-22

Locations

1 site across 1 country: United States