Phase I Open-label Trial of the Effect of GWP42003-P on Renal Function
Research type
Research Study
Full title
A Phase 1 Trial to Evaluate the Effect of Cannabidiol (CBD, GWP42003-P) on Renal Function via Measurement of Iohexol Clearance in Healthy Subjects
IRAS ID
253610
Contact name
Firas Almazedi
Contact email
Sponsor organisation
GW Research Ltd
Eudract number
2019-000163-24
Clinicaltrials.gov Identifier
19/NW/0051, REC Reference
Duration of Study in the UK
0 years, 3 months, 8 days
Research summary
The Study Drug (GWP42003-P) is an experimental drug being developed by the sponsor, with the aim of helping people with a number of conditions in the future, including epilepsy, neurodevelopmental disorders and inflammatory bowel disease.\n\nThe active part of the Study Drug, cannabidiol (CBD), is extracted from cannabis plants under controlled conditions ensuring the product is always the same. However, this part that has been extracted is non-psychoactive (does not affect the mind). \n\nThis will be a Phase 1, open label, 2-arm, placebo-controlled, parallel group trial, investigating the effect of repeated doses of GWP42003–P/placebo on kidney function in healthy subjects using Iohexol. Iohexol is a compound that is well known as a drug that can accurately measure kidney function, having been used in many studies previously.\n\nSubjects will be admitted on Day -4 and fed a standardised diet. On Day –1, subjects will be administered intravenous (i.v. – directly into the vein) doses of Iohexol, and baseline kidney function assessments will be performed. From Day 1 they will commence dosing with GWP42003-P/placebo, and will self-administer increasing doses. They will be discharged on Day 1 and undertake home dosing from Day 2 until Day 25. Subjects will return on days 8, 13 and 19 to undergo safety assessments and compliance checks, and study drug resupply on day 13. \n\nSubjects will be resident in the clinic again from days 25 to 29, volunteers will receive a standardised diet, twice daily dosing of the study drug (or placebo) and on day 28, they will receive a second dose of Iohexol to investigate changes in their kidney function, they will be dosed the following morning with GWP42003-P/placebo, and checked out from the unit. Subjects will return for a follow up visit after 14 days.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0051
Date of REC Opinion
25 Mar 2019
REC opinion
Favourable Opinion