Phase 1 trial to assess the effect of GWP42003-P on healthy adults
Research type
Research Study
Full title
A Phase 1, Open-label, Randomised, 3-way Crossover Pilot Trial to Assess the Relative Bioavailability of 3 Formulations of Cannabidiol(GWP42003-P [CBD]) in Healthy Adult Male Subjects\n
IRAS ID
225885
Contact name
Firas Almazedi
Contact email
Sponsor organisation
GW Research Ltd
Eudract number
2017-000181-30
Clinicaltrials.gov Identifier
17/NE/0042, REC
Duration of Study in the UK
0 years, 1 months, 6 days
Research summary
The Study Drug is an experimental drug that is being developed by the sponsor, with the aim of helping people with a number of conditions in the future, including epilepsy, neurodevelopmental disorders and inflammatory bowel disease.\nThe active part of the Study Drug, cannabidiol (CBD), is extracted from cannabis plants under highly controlled conditions to ensure the product is always the same. However, this part that has been extracted is non-psychoactive (does not affect the mind). \nIn this Study, 3 different formulations of CBD will be studied, a sesame oil formulation, an aqueous (containing water) formulation and a capsule. This is the first time that the aqueous formulation and the capsule are being studied in humans. The dose that will be studied is lower than the equivalent dose found to be well tolerated in animals. In humans, repeat doses of up to 3000 mg per day of the Study Drug have been studied and found to be well tolerated. Single doses of up to 6000 mg of the Study Drug have also been studied and found to be well tolerated.\n\nTwelve healthy male participants will be participating in this study. Each participant will receive a single dose of the Study Drug on 3 separate occasions; that is, they will receive each formulation once, 1 in each Treatment Period. The order in which they will receive the formulations will be determined at random. \n\nThe total duration of trial participation for each participant (from screening through to the follow up visit) is anticipated to be approximately 11 weeks, consisting of 3 inpatient visits, 9 outpatient visits and one post-study follow-up visit.\n
REC name
North East - York Research Ethics Committee
REC reference
17/NE/0042
Date of REC Opinion
11 May 2017
REC opinion
Favourable Opinion