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

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.

Conditions

• Smoking

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.

Sponsors & Collaborators

• Philip Morris Products S.A.

  lead INDUSTRY

Principal Investigators

• Christelle Haziza, PhD · Philip Morris Products S.A.

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-19

Primary Completion

2026-07-29

Completion

2026-12-18

Countries

• United Kingdom

Study Locations