STUDY TO ASSESS THE PK OF CANNABIDIOL PRODUCTS IN HEALTHY SUBJECTS
Research type
Research Study
Full title
A RANDOMISED, CONTROLLED, SINGLE-CENTRE, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS OF CANNABIDIOL IN VAPOUR, ORAL POUCH, EDIBLE, AND CHEW PRODUCTS IN HEALTHY ADULT SUBJECTS
IRAS ID
288334
Contact name
Sunu Valasseri
Contact email
Sponsor organisation
British American Tobacco (Investments) Ltd
Duration of Study in the UK
0 years, 3 months, 15 days
Research summary
Summary of Research
Cannabidiol (CBD) is a chemically and phytogenetically related phenolic terpene derived from hemp (Cannabis sativa L). It is a white to pale-yellow crystalline non-hygrosopic solid and the second-most abundant cannabinoid found in the cannabis plant, behind tetrahydrocannabinol (THC). CBD is insoluble in aqueous media irrespective of pH, but freely soluble in some organic solvents such as ethanol and oils.
The main purpose of this study is to characterise the PK of CBD following the use of a vapour CBD product, a CBD-infused oral pouch, and a prototype edible CBD product. In addition, changes in mood, cognitive function, and physiological endpoints will be also be assessed.
Subjects 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.
For the vapour product, a placebo e-liquid is included as a control for the subjective and physiological measures, including VAMS, product satisfaction questionnaire, cognitive assessments, and physiological assessments.
The washout period between product use sessions is considered sufficient to prevent carryover effects.There will be a screening period of 28 days for all screening to take place. The duration of the study is 20 days (Day -3 of Period 1 until Day 3 of Period 6) of continuous confinement in the CRU.
Summary of Results
Delivery format & route of administration (RoA) affects CBD delivery, with Vapour having the highest plasma concentration followed by Chew > Edible and Pouch.
Route of administration affects CBD metabolite pharmacokinetic profile with Chew having the highest plasma concentration, followed by Edible, Vapour and pouch.
Consumption of high fat food with CBD Vapour did not increase CBD plasma concentration.
Subjective product liking was highest for Vapour, followed by Edible, Chew and Pouch.
There were no significant changes in physiological and cognitive assessments following CBD product use compared to placebo.
REC name
HSC REC A
REC reference
20/NI/0114
Date of REC Opinion
2 Oct 2020
REC opinion
Further Information Favourable Opinion