FIH Clinical Trial Testing GWP4202541 in healthy volunteers
Research type
Research Study
Full title
A Phase I, First-in-Human, Randomized, Double blind, Placebo controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Trial in Healthy Adults and Healthy Elderly Adults
IRAS ID
273576
Contact name
Firas Almazedi
Contact email
Sponsor organisation
GW Research Ltd.
Eudract number
2019-003165-17
Clinicaltrials.gov Identifier
20/NE/0001, REC ref
Duration of Study in the UK
0 years, 8 months, 27 days
Research summary
Behavioural and psychological symptoms in dementia (BPSD) represent a group of symptoms and behaviours which occur in subjects with dementia. These symptoms constitute a major component of the dementia syndrome and are estimated to affect up to 90% of patients with dementia. Antipsychotic medications are commonly used to treat BPSD; however, these are minimally effective and have a number of side effects.\nRecent studies have shown that cannabinoids can be used in the treatment of agitation and aggression in patients with dementia or Alzheimer’s at doses equivalent to 5-10mg of Δ9 tetrahydrocannabinol (THC) per day. \nGWP4202541 is an orally administered botanical drug product for the treatment of BPSD, it is a combination of cannabinoids including CBD and THC and non CBs. This study will be in 3 parts. \n\nIn Part A, 32 healthy adult subjects (18-65 yrs old) will be studied in 4 groups. All the groups will participate in 1 treatment period with one dose of GWP4202541, with the exception of A2, who will also take GWP4202541 in the fed state to assess how the drug is metabolised with food. \n \nIn Part B, 40 healthy adults (18-65 yrs old) will be studied in 4 groups (B1 to B4). Each subject will receive an oral dose of GWP4202541 or placebo, twice a day for 10, 12, 17 or 19 days respectively. \n \nIn Part C, 20 healthy elderlies (66-80 yrs old) will be studied in 2 groups, the dose level, frequency and if fed or fasted will be determined from the safety data from Parts A and B of the study. \n
REC name
North East - York Research Ethics Committee
REC reference
20/NE/0001
Date of REC Opinion
24 Jan 2020
REC opinion
Further Information Favourable Opinion