CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
P1R stick +2 moreother
Likely dose
Not stated in 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/NCT05789420
NCT05789420N/ACompleted
CompareCT.gov

A Single-center, Randomized, Controlled, Open-label Study in Smoking Healthy Subjects to Investigate the Nicotine Pharmacokinetic Profiles Following Single Use of Tobacco Heating System (THS) With a Regular or a Menthol Stick, Compared to Smoking of a Single Combustible Cigarette (CIG)

Philip Morris Products S.A.·interventional·Posted Mar 29, 2023·Updated Nov 22, 2024

In Brief

A clinical study evaluating P1R stick, P1M stick, and 1 other intervention for Smoking, Tobacco. Completed, enrolled 31 participants across 1 site.

Detailed Summary

The purpose of this study was to describe the nicotine pharmacokinetic (PK) profile during and after single use of THS (Induction heating technology, with either a regular or menthol stick) compared to singular CIG smoking in healthy adult subjects. In addition, pharmacodynamic effects (subjective effects) were evaluated to provide further insights on product acceptance and likelihood to use the THS again. Safety was assessed throughout the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking, Tobacco
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedMar 29, 2023
Enrollment StartFeb 16, 2023
Primary CompletionApr 2, 2023
Study CompletionMay 5, 2023
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.3 years ago

Interventions

P1R stickother

Regular flavor tobacco stick

P1M stickother

Mentholated flavor tobacco stick

CIGother

Subjects' preferred brand of commercially available, regular or mentholated cigarettes