Nicotine PK of M1 Platform Compared to Cigarettes and Inhalator
Research type
Research Study
Full title
An Open-Label, Randomised, Controlled, Crossover Study to Assess Nicotine Pharmacokinetics of the M1 Platform Compared to Combustible Cigarettes and the Nicorette Inhalator
IRAS ID
304673
Contact name
Samuel Israel
Contact email
Sponsor organisation
Juul Labs, Inc.
Eudract number
2021-005476-19
Duration of Study in the UK
0 years, 2 months, 5 days
Research summary
This study is an Open label, randomised, controlled, crossover study evaluating nicotine levels (pharmacokinetics) of the M1 Platform electronic nicotine delivery system (D1+ device with a 5% nicotine and Virginia Tobacco Flavour J2 JUULpod, D1 + Device with 3% nicotine and Menthol Flavour J2 JUULpod and D1+ Device with 5% nicotine and Menthol Flavour J2 JUULpod), a combustible cigarette, and the Nicorette Inhalator.\n\nParticipants who successfully complete the screening assessments will use one of the study products at each of 5 Study Visits during controlled puffing sessions (each controlled puff sequence session includes 10 puffs of 3 seconds each, spaced 30 seconds apart), according to a randomisation schedule. Each Study Visit will involve a check-in on Day-1, 5 controlled puffing sequence sessions spaced 60 minutes apart on Days 1, 2, 3, 4, and 5 and a check-out later on Day 1. Participants will receive a follow-up telephone call approximately 7 days after their last Study Visit.\n\nThe study products are as follows:\nA\tM1 Platform (D1+ Device with a 5% Nicotine and Virginia Tobacco Flavour J2 JUULpod)\nB\tM1 Platform (D1+ Device with 3% Nicotine and Menthol Flavour J2 JUULpod)\nC\tM1 Platform (D1+ Device with 5% Nicotine and Menthol Flavour J2 JUULpod)\nD\tNicorette 15 mg Inhalator\nE\tParticipants’ usual brand combustible cigarette\n\n\nThe total study duration is anticipated to be no more than 7 weeks per study participant.\n\nThe study will be conducted at a single research centre (Labcorp Clinical Research Unit Ltd, Leeds). Male or female current smokers who have either tried or are occasional users of e cigarettes will be enrolled to obtain 30 completers of all 5 Study Visits.\n
REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0770
Date of REC Opinion
20 Dec 2021
REC opinion
Further Information Favourable Opinion