Phase 1, randomised, food effect, PK study of GWP42003-P capsules
Research type
Research Study
Full title
A Phase 1, Randomised, 2 part Trial to Investigate the Effect of Food on Cannabidiol (GWP42003-P, CBD) Capsule versus Oral Solution Pharmacokinetics (PK) and to Assess the Single and Repeat Dose PK, in Healthy Subjects
IRAS ID
248660
Contact name
Firas Almazedi
Contact email
Sponsor organisation
GW Research Ltd
Eudract number
2018-002027-42
Clinicaltrials.gov Identifier
18/NE/0197, REC Reference number
Duration of Study in the UK
0 years, 3 months, 22 days
Research summary
GWP42003-P is the substance for purified cannabidiol (CBD) from the cannabis plant being developed by GW pharma, CBD is not associated with the effects cannabis is traditionally known for and is being investigated for the treatment of a number of conditions, namely some treatment resistant childhood epilepsies like Dravet syndrome and Lennox-Gastaut syndrome, central nervous system disorders and inflammatory disorders. \n\nThis study is being carried out to investigate how food affects the way the drug is used by the body, they will be testing two versions of the drug, one is a capsule and the other is an oral solution. They will also be testing how the drug is used by the body with repeated doses of the capsule formulation of the drug. \nThe study will take part in 2 parts\n\nThe first part will be investigating the effect of food on the solution and the capsules of the study drug in a fed and fasted state. There will be four treatment sequences for 12 subjects, which will be randomly allocated to each subject. There will be a 2 week period before each dosing period. \n\nThe second part of the study will consist of 3 groups of 12 subjects; they will be given three different oral doses of the study drug in its capsulated form (450mg, 750mg and 1500mg) the order in which these will be given will differ for each subject. After each dose they will wait for 3 weeks before receiving the next dose. \n
REC name
North East - York Research Ethics Committee
REC reference
18/NE/0197
Date of REC Opinion
18 Jul 2018
REC opinion
Further Information Favourable Opinion