Study to assess exposure of selected HPHC between THS use & CIG use
Research type
Research Study
Full 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 heating profiles as compared to continuing CIG smoking
IRAS ID
362835
Contact name
Devinda Weeraratne
Contact email
Sponsor organisation
Philip Morris Products S.A
Duration of Study in the UK
0 years, 6 months, 16 days
Research summary
The study is a randomised, 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 heating profiles as compared to continuing CIG smoking.
The overall goal of this study is to demonstrate reduced exposure to selected HPHC of CIG smoke in healthy smokers switching to a THS with self-selected heating profiles as compared to smokers who continue CIG smoking in a confinement setting for 5 days followed by a partial cross-over of a 2-days of nicotine pharmacokinetic (PK) assessment (4 PK periods) followed by a final ambulatory phase of 53 days (55 days for participants randomized to CIG arm without PK periods).
The investigational products are: TP18 ‘Extend’ profile (THS1), TP18 ‘Intense’ profile (THS2), TP18 ‘Optimal’ profile (THS3), TP18 ‘Original’ profile (THS4), THS 3.0 (THS5), and Cigarette (CIG).
108 participants in total (18 participants in each arm) will be randomised to one of the 6 arms. Participants who will be randomised to THS5 or TP18 (THS1 to THS4) will be assigned to a randomisation sequence which will contain the arm they are randomised for the Reduced Exposure Period in the Confinement period and the product sequence for the PK period.Participants will be informed of their randomised study arm by the study site staff on Day 1. The entire study duration per participant will be 77 to 104 days.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
25/LO/0873
Date of REC Opinion
26 Jan 2026
REC opinion
Further Information Favourable Opinion