GWEP1675 CBDV
Research type
Research Study
Full title
A Phase 1, Open-label, Randomized, Crossover Pilot Trial to Assess the Relative Bioavailability of Cannabidivarin (GWP42006 [CBDV]) Formulations in Healthy Adult Male Subjects
IRAS ID
217709
Contact name
Firas Almazedi
Contact email
Sponsor organisation
GW Research Ltd
Eudract number
2016-004221-16
Duration of Study in the UK
0 years, 3 months, 10 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 chronic pain caused by problems with signals from the nerves.\nThe active part of the Study Drug, cannabidivarin (CBDV), 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, 2 different formulations of GWP42006 will be studied, a sesame oil formulation and an aqueous (containing water) formulation. This is the first time that the aqueous formulation is being studied in humans. The dose that will be studied is lower than the equivalent dose found to be well tolerated in animals. Single and repeat doses of up to 800 mg per day of the other formulation of the study drug have been studied in humans and found to be well tolerated. The doses that will be studied in this study are lower than the well-tolerated doses in the previous studies.\nTwelve healthy male participants will be participating in this study, with each subject receiving a single dose of GWP42006 on 4 separate occasions. Each person will receive the study drug in a sesame oil formulation, whilst fasted overnight and after a high fat meal. They will receive it again as an aqueous formulation, again after an overnight fast and after a high fat meal.\nDepending on the safety information and drug levels observed after the above treatment periods, a decision will be made to either decrease or increase the dose of the aqueous formulation (either fed or fasted state) for a fifth treatment period. \nThe total duration of trial participation for each subject (from screening through to the follow up visit) is anticipated to be approximately 13 weeks.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0475
Date of REC Opinion
15 Feb 2017
REC opinion
Further Information Favourable Opinion