CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
E-cigarette +4 moreother
Likely dose
P4M3-1.7%LAfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03379740
NCT03379740N/ACompleted
CompareCT.gov

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

Philip Morris Products S.A.·interventional·Posted Dec 20, 2017·Updated Nov 22, 2019

In Brief

A clinical study evaluating E-cigarette, P4M3-1.7%, and 3 other interventions for Vaping and Nicotine Absorption. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaping, Nicotine Absorption
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 20, 2017
Enrollment StartJul 11, 2017
Primary CompletionAug 14, 2017
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 8.5 years ago

Interventions

E-cigaretteother

Subject's own e-cigarette

P4M3-1.7%other

P4M3 e-liquid concentration of 1.7% nicotine without lactic acid

P4M3-1.7%LAother

P4M3 e-liquid concentration of 1.7% nicotine with lactic acid

P4M3-3%LAother

P4M3 e-liquid concentration of 3% nicotine with lactic acid

P4M3-4%LAother

P4M3 e-liquid concentration of 4% nicotine with lactic acid