Phase 1 double-blind single ascending multiple dose CBD PK trial
Research type
Research Study
Full title
A phase 1, randomized, double-blind, placebo-controlled, 2-part single ascending dose, and multiple ascending dose trial to evaluate the pharmacokinetics of Cannabidiol (GWP42003 P; CBD) in healthy adult Japanese and Caucasian subjects.
IRAS ID
270626
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
GW Research Ltd.
Eudract number
2019-003027-38
Duration of Study in the UK
0 years, 7 months, 20 days
Research summary
Summary of Research\nThis study assesses the pharmacokinetic profile of GWP42003-P and its major metabolites in healthy adult Japanese and Caucasian volunteers.\n\nGWP42003-P (cannabidiol, CBD) is derived from the cannabis plant. It is partially metabolised by CYP2C19 and has proved efficacious in treating severe forms of childhood epilepsy. It also shows anti inflammatory, neuroprotective, and antipsychotic activity. \n\nThe PK and safety of GWP42003-P have been extensively explored in patient and healthy subject trials performed outside Japan. GWP42003-P is now a licensed product in the US. The Sponsor intends to undertake clinical efficacy trials in Japanese patient populations. To determine safe and effective doses for such trials and formally bridge to the data package in Caucasian populations for a new drug application, it is important to determine the disposition and safety of GWP42003-P in Japanese and Caucasian populations.\n\nThis is a double-blind, placebo-controlled, two-part study. Screening occurs within 28 days prior to first dosing. Part A involves 32 healthy volunteers who are extensive CYP2C19 metabolisers (16 Caucasian; 16 Japanese) across two cohorts. Each cohort completes three treatment periods - two Single Ascending Dose (SAD) periods of seven days followed by one Multiple Ascending Dose (MAD) period of 13 days that involves six days of twice daily dosing followed by a single dose on Day 7. In each treatment period, subjects are randomised 3:1 to receive GWP42003-P or placebo. Each period is interspersed by a minimum washout of 14 days.\n\nPart B occurs after review of safety/pharmacokinetic data from Part A and involves 16 healthy Japanese subjects (CYP2C19 poor metabolisers). Part B consists of one SAD and one MAD period.\n\nAll trial aspects will be performed at a Phase I clinical trials unit. Available data suggests an acceptable risk-benefit profile of GWP42003-P. Including healthy volunteers avoids confounding effects of disease and concomitant medication.\n\nSummary of Results\nNot provided by Sponsor
REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/1596
Date of REC Opinion
22 Nov 2019
REC opinion
Further Information Favourable Opinion