PK Study of Nicotine Delivery From Selected Heated Tobacco Products
Research type
Research Study
Full title
A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes
IRAS ID
304914
Contact name
Nadine Abdullah
Contact email
Sponsor organisation
Nerudia Ltd – an Imperial Brands PLC company
Duration of Study in the UK
0 years, 0 months, 17 days
Research summary
Summary of Research
Imperial Brands PLC aim to increasingly transition adult smokers, who would otherwise continue to smoke, to NGPs that are potentially less harmful than CC. Heated tobacco and electronic cigarettes (E- cigarettes) are two platforms that are being increasingly recognized by public health bodies and regulators as having the potential to reduce the risk of continued smoking. Heated tobacco products also offer greater optionality in parts of the world where vaping is not permitted or where smokers prefer heated tobacco. Imperial Brands have therefore added the Pulze heated tobacco product (HTP) device and iD stick heated tobacco consumables to a growing repertoire of NGP.
This is a single site (Celerion Belfast), being conducted to evaluate the overall performance of Imperial Tobacco’s Pulze HT product and three flavoured tobacco sticks. It will provide data on nicotine blood concentration, product perception and preference, product usage as measured by topography and tolerability and safety of each of the products compared to OBCC.
24 combustible cigarette smokers (males and/or females), after being deemed healthy, will participate in the study for up to 35 days, including an up to 28-day screening period, a 5-day confinement at the CRU, and a follow up telephone call will be conducted 7 days after last use of the study product.
Subjects will be randomized on Day 1 to one of the following study products:
A Pulze HT device with iD Intense American Blend stick
B Pulze HT device with iD Regular American Blend stick
C Pulze HT device with iD Regular Menthol stick
D Subject’s Own Brand Combustible CigarettesSubjects will be randomised to study product sequences to minimize assignment bias. A crossover design is used to reduce the residual variability as every subject acts as their own control.
Summary of Results
Pulze & iD products under conditions of test, have a favourable short-term Safety and Tolerability profile.
Pulze & iD products deliver nicotine efficiently to the blood, with a comparable speed of delivery to that of cigarette.
Pulze & iD products deliver nicotine efficiently to the blood but to significantly lower levels than subjects own brand cigarette.
Pulze & iD products significantly reduce urges to smoke although not as great as a cigarette.
Pulze & iD products have relatively low satisfaction and reward scores, although with slightly higher relief scores compared to cigarette.
The characteristics of using of Pulze & iD products (i.e. topography) shows that there is work to further understand puffing parameters in this category. Topography is different in some parameters compared to using a cigarette.REC name
HSC REC A
REC reference
21/NI/0144
Date of REC Opinion
21 Oct 2021
REC opinion
Further Information Favourable Opinion