Clinical trial to investigate doses of GWP42003-P in healthy subjects
Research type
Research Study
Full title
A Phase 1, Open-Label, Sequential-Group Trial to Evaluate the Gastrointestinal Tolerability of Two Daily Doses of Cannabidiol (GWP42003-P; CBD) Capsules in Healthy Subjects
IRAS ID
276057
Contact name
Ashley Brooks
Contact email
Sponsor organisation
GW Research Ltd.
Eudract number
2019-003809-95
Clinicaltrials.gov Identifier
20/NE/0041, REC reference
Duration of Study in the UK
0 years, 3 months, 25 days
Research summary
GWP42003-P is purified CBD, a cannabinoid under development by GW Research Ltd. (GW) for the treatment of treatment-resistant epilepsies. \n\nPart A will be a single-group, non-randomized, dose-titration study with 4 days per dose level and will assess the effect of increasing doses on immediate vomiting in healthy adult subjects. Subjects will be assigned to a single group of 20 to receive titration doses of GWP42003-P capsules over 16 days as follows:\n• Day 1 to Day 4, 300 mg twice daily.\n• Day 5 to Day 8, 450 mg twice daily.\n• Day 9 to Day 12, 600 mg twice daily.\n• Day 13 to Day 15, 750 mg twice daily.\n• Day 16, 750 mg (morning dose only).\n\nPart B will be randomized and will assess 2 individual dose levels of GWP42003-P capsules administered twice daily without titration. Progression to Part B will require joint agreement of the investigator and the sponsor at a minimum and will follow review of safety and tolerability data from Part A by key members of the trial team, including the investigator and sponsor representatives, and if at each dose level, 10% or fewer of the subjects experience vomiting. \n\nSubjects will be randomized to 1 of 2 groups of 6 to receive twice daily doses of GWP42003-P over 2 days as follows:\n• Group 2: 450 mg twice daily.\n• Group 3: 750 mg twice daily.\n\nThe aim of the study is to assess in healthy subjects the gastrointestinal (GI) tolerability of multiple administrations of GWP42003-P capsules when administered twice daily under fed conditions and to evaluate in healthy subjects the overall safety and tolerability following multiple or repeat administrations. In addition, the study seeks to investigate how the drug is broken down by the body under fed conditions.
REC name
North East - York Research Ethics Committee
REC reference
20/NE/0041
Date of REC Opinion
26 Feb 2020
REC opinion
Further Information Favourable Opinion