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Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Sponsor: Philip Morris Products S.A.
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
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.
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.
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.
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.
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.
CIG (Cigarette)
Current cigarette smokers will use their usual brand of commercially available CIG.
Locations (1)
Celerion
Belfast, United Kingdom