Midazolam probe study with CBD in healthy volunteers
Research type
Research Study
Full title
A Phase 1, Open-Label, Fixed Sequence Crossover Trial to Investigate the Effect of Cannabidiol (GWP42003 P; CBD) on the CYP3A4 Probe Midazolam in Healthy Subjects
IRAS ID
226739
Contact name
Firas Almazedi
Contact email
Sponsor organisation
GW Research Ltd
Eudract number
2017-002161-22
Clinicaltrials.gov Identifier
REC 17/NE/0112 , REC
Duration of Study in the UK
0 years, 2 months, 6 days
Research summary
The Study Drug is an experimental drug that is 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.\nThe active part of the Study Drug, cannabidiol (CBD), is extracted from cannabis plants under highly controlled conditions to ensure the product is always the same. However, this part that has been extracted is non-psychoactive (does not affect the mind). \nIn developing new medicines it is vital that we understand how the Study Drug will interact with other drugs; drug interactions can lead to severe side effects. This is a drug interaction study with another drug called Midazolam, which is usually used as a sedative (although at much higher doses than being used in this study). Midazolam is being used as it is recommended by the European Medicines Association (EMA) to act as a substrate for one of the liver enzymes (CYP3A4). This means that midazolam is metabolised (broken down) mainly by this specific liver enzyme which also plays a role in breaking down many other medications, and this study would give us an idea if the Study Drug (CBD) increases, reduces, or has no impact on the activity of this liver enzyme. This study will also give us an idea about what will happen when the Study Drug is co-administered with drugs that are similar to Midazolam. \n\nSixteen subjects will participate in this study; they will be resident in the clinical research unit (CRU) from Day -2 to Day 1, and subsequently from Day 24 to Day 26. They will receive midazolam on Day -1 and Day 25. They will also receive a sesame oil placebo on Day -1. Subjects will self-administer escalating doses of GWP42003 P from Day 1 to Day 25. There will be a nonresidential visit on Day 22, and a follow-up visit will take place 7 to 10 days after the final dose of the Study Drug. \n\nThe total duration of trial participation for each subject (from screening through to the follow up visit) is anticipated to be approximately 11 weeks.\n
REC name
North East - York Research Ethics Committee
REC reference
17/NE/0112
Date of REC Opinion
13 Jul 2017
REC opinion
Favourable Opinion