Effect of GWP42003-P over exposure of clobazam and N-CLB
Research type
Research Study
Full title
A phase 1, open-label, pharmacokinetic trial to investigate the effects of steady state cannabidiol (GWP42003 P, CBD) over a 20 fold dose range on exposure of clobazam and its major active metabolite N-desmethyl-clobazam (N-CLB) following single doses of CLB in healthy subjects.
IRAS ID
238911
Contact name
Firas Almazedi
Contact email
Sponsor organisation
GW Research Ltd
Eudract number
2017-005086-46
Clinicaltrials.gov Identifier
18/LO/0243, REC
Duration of Study in the UK
0 years, 4 months, 5 days
Research summary
GWP42003-P is a drug being developed with purified cannabidiol (CBD) for the treatment of a number of conditions, including epilepsy and Lennox-Gastaut Syndrome (LGS) a severe form of epilepsy in young children.\nCBD is extracted from cannabis plants; however it is the part of the chemical that is not associated with effects on the mind that cannabis use is traditionally known for. \nTo further investigate the study drug it is important to assess how it works with other drugs, some interactions can affect the way the body uses other drugs or the drug being investigated, the study will investigate how well the study drug interacts with a commonly used anti-epilepsy drug called clobazam(CLB). Previous studies have shown a significant interaction between clobazam and CBD causing an increase of N-CLB (N-desmethyclobazam - a form of clobazam once made active in the body). Studies have shown that administration of CBD with CLB can cause increases of up to 3 fold increase in N-CLB, the purpose of this study is to investigate a lower dose of CBD that may have a lower or negligible effect on CLB and N-CLB exposure. Due to CLB being an already established therapy which is used with CBD it is important to understand this interaction to support the clinical development of the study drug in the treatment of epilepsy. \nUp to 60 subjects will be enrolled on the trial, there will be 5 arms(12 in each arm) each arm will be given a single dose of 10mg CLB and differing dosages of the study drug as well as differing frequency of dosing. Arm 5 will be given fluconazole (400mg as a loading dose with 200mg daily thereafter) and not the study drug with CLB.\nArms 1 and 5 will take place over 35 days and arms 2, 3 and 4 will take place over 46 days. \n
REC name
London - Brent Research Ethics Committee
REC reference
18/LO/0243
Date of REC Opinion
28 Mar 2018
REC opinion
Further Information Favourable Opinion