Nicotine PK, PD & subjective effects of THS compared to cigarettes
Research type
Research Study
Full title
A single-center, randomized, controlled, open-label, cross-over study in currently smoking adult participants to investigate the nicotine pharmacokinetics and pharmacodynamics of Tobacco Heating System (THS) with LEVIA, a tobacco-free nicotine-containing product compared to THS with TEREA, a heated tobacco product and to cigarettes
IRAS ID
355951
Contact name
Amin Sammour
Contact email
Sponsor organisation
Philip Morris Products S.A
Duration of Study in the UK
0 years, 1 months, 4 days
Research summary
This study will investigate how different nicotine products affect the body by comparing a tobacco-free nicotine product called LEVIA, a tobacco-containing product called TEREA, and regular cigarettes. Adult smokers will participate, using each product in different orders. The study will be conducted in two parts: one where participants use the products as they normally would over two periods and with two sequences, and another part where each product is tested on separate days using a more structured design called Williams design, with three periods and six sequences. The main goal is to compare how nicotine from each product is processed in the body and its effects on the participants.
The duration of the entire study for each participant will be up to 37 days. This will include a screening period of up to 28 days (Day -30 to Day -2) prior to Admission (Day -1), 5 days of confinement (after enrollment) on Day -1 to time of Discharge on Day 5 (5 overnight stays), and a 3-day safety follow-up period (from time of Discharge on Day 5 or Early Termination plus three days).
REC name
Wales REC 1
REC reference
25/WA/0106
Date of REC Opinion
9 May 2025
REC opinion
Unfavourable Opinion