NCT03953183

Product Use and Adaptation, Safety and Tolerability of P3P in Adult Healthy Smokers Switching to it

A Randomized, Double-blinded, 2-arm Parallel Groups, Single Center Study to Assess Product Use and Adaptation, Safety and Tolerability of P3P, a Novel Nicotine-containing Product, in Adult Healthy Cigarette Smokers Switching to One of Two P3P Variants for One Month

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the product use and adaptation in adult, current cigarette smoking subjects between baseline and after one month of use of one of two P3P variants. The effect of P3P use behavior on nicotine pharmacokinetic (PK) profile, acceptability, as well as the safety and tolerability of P3P over a period of 1 month will be investigated.

Detailed description

This is a study of daily use of up to 15 P3P products over one month, including 2 confinement periods (2 overnight stays at the beginning of the study and 1 overnight stay at the end of the exposure period). During the confinement visits, nicotine PK from P3P exposure will be assessed as well as pharmacodynamic effects related to craving, sensory parameters, product experience, and product acceptance. Between the two confinement periods, subjects will return to the investigational site for weekly ambulatory visits during which P3P will be resupplied and selected safety and other study assessments will be performed. From the start of the exposure period onwards, subjects will be instructed not to smoke or use other tobacco or nicotine containing products and to use P3P exclusively.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
OTHER	P3P-1mg	P3P-1mg (P3P product containing 1mg of nicotine.)
OTHER	P3P-2mg	P3P-2mg (P3P product containing 2mg of nicotine.)

Timeline

• Start date: 2019-04-23
• Primary completion: 2019-08-14
• Completion: 2019-10-25
• First posted: 2019-05-16
• Last updated: 2020-12-14
• Results posted: 2020-12-14

Locations

1 site across 1 country: Russia