2 Part Study of Cannabidiol in Healthy Volunteers
Research type
Research Study
Full title
A Randomised, 2-Part Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Intravenous Doses (Part A) and Absolute Bioavailability (Part B) of Cannabidiol (GWP4200-P; [CBD]) in Healthy Adult Subjects.
IRAS ID
212933
Contact name
Neelum Khan
Contact email
Sponsor organisation
GW Pharmaceuticals
Eudract number
2014-005236-33
Duration of Study in the UK
0 years, 2 months, 11 days
Research summary
This is a two-part study. Part A is a single ascending intravenous (IV) dose double-blind design, Part B is an open-label, crossover design incorporating 2 treatment periods with oral and IV dosing of cannabidiol (CBD), being developed for the potential treatment for children with treatment-resistant epilepsy and Neonatal Hypoxic Ischemic Encephalopathy (NHIE) a condition caused by lack of oxygen to the brain in newborn babies.\n\nThe study population will be healthy volunteers aged 18-55 inclusive.\n\nPart A comprises 4 cohorts, incorporating sentinel dosing of 4 single IV doses in a dose escalation pattern. 32 volunteers will participate in Part A. All volunteers will receive either the study drug or placebo.\nTwo volunteers in each cohort (one receiving IMP and the other receiving placebo) will be dosed one hour apart. No further volunteers will be dosed in each cohort until 24 hours after dosing the second volunteer. \n\nThe decision to proceed with the next cohort, next dose level will be made at a safety review meeting.\n\nStudy duration for Part A will be approximately 39 days, (one two-night stay).\n\nPart B is an open-label design, incorporating a 7-day washout period between dosing periods. \n\nPart B involves one cohort of 12 volunteers divided into 2 groups. Each volunteer will complete two treatment periods; they will receive an oral dose and an IV dose of CBD in a crossover fashion. \n\nGroup 5A will receive a single fasted oral dose of 1500 mg and Group 5B will receive a single IV fasted dose, (determined on completion of Part A, following safety review) in Period 1. Following the washout period both groups will be crossed over to receive the alternative treatment in Period 2. \n\nStudy duration for Part B will be approximately 46 days including the screening period, and two stays for two nights.\n\n
REC name
HSC REC A
REC reference
16/NI/0161
Date of REC Opinion
2 Sep 2016
REC opinion
Further Information Favourable Opinion