A Phase 1 open-label study to assess the safety and PK of novel CBD soft-gel capsule
Research type
Research Study
Full title
A Phase 1 study to assess the safety and pharmacokinetics of novel Cannabidiol (CBD) soft-gel capsule formulation (NW300EMCBD) in healthy volunteers.
IRAS ID
1011359
Contact name
Grace Blest-Hopley
Contact email
Sponsor organisation
NW PharmaTech
Research summary
This study aims to test a new version of cannabidiol (CBD) to understand how the body processes it and to ensure it is safe for use in healthy volunteers. CBD is a natural compound found in the cannabis plant that has shown promise in treating various medical and mental health conditions. Currently, an FDA-approved CBD drug called Epidiolex is used to treat epilepsy. However, many CBD products don’t absorb well in the body when taken by mouth, making them less effective and requiring higher doses.
NWPharmaTech has developed a new CBD formulation designed to improve how the body absorbs and processes it. This study will compare the safety and tolerability of two different doses of the new formulation with Epidiolex.
Participants in the study will take both doses of the new formulation and Epidiolex. Researchers will examine how the body absorbs, distributes, and eliminates each formulation. The goal is to find the best dose and formulation that works effectively while minimizing side effects.
REC name
London - Riverside Research Ethics Committee
REC reference
25/LO/0159
Date of REC Opinion
15 Apr 2025
REC opinion
Further Information Favourable Opinion