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RECRUITING
NCT07443631
NA

Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants

Sponsor: Philip Morris Products S.A.

View on ClinicalTrials.gov

Summary

This is a randomized, controlled, open-label, 6 parallel arms study to assess reduced exposure of biomarkers of exposure (BoE) of selected HPHC in smokers switching to TP18 (a prototype heated tobacco device) or THS relative to smokers who continue smoking CIG after 5 days of confinement period, followed by 2 days of pharmacokinetic (PK) period of single use of THS/TP18 and CIG, and followed by an ambulatory period.

Official title: A Randomized, Controlled, Open-label, 6 Parallel Arms Study to Assess Exposure to Selected Harmful and Potentially Harmful Constituents (HPHC) of Cigarette (CIG) Smoke in Adult Smokers Switching to Tobacco Heating Systems (THS/TP18) With Different Device Variants as Compared to Continuing CIG Smoking

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2026-02-19

Completion Date

2026-12-18

Last Updated

2026-03-02

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

THS1 (TP18 variant 1)

TP18 prototype variant "1" (THS1) and associated tobacco sticks. The Sponsor will supply two types of sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants can choose either or both variants.

OTHER

THS2 (TP18 variant 2)

TP18 prototype variant "2" (THS2) and associated tobacco sticks. The Sponsor will supply two types of sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants can choose either or both variants.

OTHER

THS3 (TP18 variant 3)

TP18 prototype variant "3" (THS3) and associated tobacco sticks. The Sponsor will supply two types of sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants can choose either or both variants.

OTHER

THS4 (TP18 variant 4)

TP18 prototype variant "4" (THS4) and associated tobacco sticks. The Sponsor will supply two types of sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants can choose either or both variants.

OTHER

THS5 (THS 3.0 reference device)

THS 3.0 device (reference) and the corresponding tobacco sticks will be provided by the Sponsor. There are two variants of the sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants may choose either variant or both.

OTHER

CIG (Cigarette)

Current cigarette smokers will use their usual brand of commercially available CIG.

Locations (1)

Celerion

Belfast, United Kingdom