Randomized nicotine PK study evaluating 5 products
Research type
Research Study
Full title
An Open Label, Randomized, Controlled, Crossover Trial to Measure Nicotine Pharmacokinetics Using the JUUL ENDS with Existing and New Vaporization Pods and a Combustible Cigarette in Healthy Adult Subjects
IRAS ID
265554
Contact name
Daniel Jabbari
Contact email
Sponsor organisation
JUUL Labs Inc
Duration of Study in the UK
0 years, 1 months, 2 days
Research summary
A PK study utilized a JUUL 5% nicotine salt e-liquid formulation compared to a combustible cigarette in a randomized, controlled, crossover study. This trial will provide an understanding of the levels of plasma nicotine obtained with use of the company’s current JUUL Device with the current pod (J1) containing 2 different nicotine concentrations [18mg/mL and 5% (59mg/mL)] compared to the current JUUL Device and a new pod (J2) containing either 9mg/mL or 18mg/mL nicotine. The J2 pod is similar in design to the existing J1 pod. The main difference is the use of different wicking materials which deliver the nicotine-containing solution from the reservoir to the heating coil. The trial will utilize an open label, randomized, cross-over design, to enable both intra-subject and inter-subject comparison. A sample size of twenty (20) subjects with PK profiles are expected to be adequate for the estimation of the pharmacokinetic profiles of the test products.
REC name
HSC REC A
REC reference
19/NI/0117
Date of REC Opinion
2 Jul 2019
REC opinion
Further Information Favourable Opinion