NCT05032807

Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Cannabidiol (CBD) has been approved as a treatment for rare childhood epilepsies and could be an effective treatment for psychotic disorders, anxiety disorders and addictions. It is available as an oral liquid and as standard oral capsules. The bioavailability of oral cannabidiol is poor (only around 5-10% is absorbed), particularly in the fasted state. With food, its absorption is much higher. In one study, a high-fat breakfast increased the maximum plasma concentration by 4-5 times. As a result of this food effect, when prescribing standard oral formulations of CBD, clinicians should provide advice on dosing the drug according to mealtimes, otherwise, there may be an increased risk of side effects or limited effectiveness. One way to reduce the food effect and improve bioavailability is to use lipid excipients. In the present study, the investigators will evaluate CBD at the dose that is effective in patients with chronic psychosis (1000mg). The novel formulation will use lipids that are all EU pharmacopoeia approved and have been used in medicinal products before. The study aims to assess whether a novel lipid formulation can increase the bioavailability of oral CBD in the fasting state.

Conditions

• Absorption; Chemicals

Interventions

Type	Name	Description
DRUG	Standard formulation	Cannabidiol 1000mg standard formulation, single dose, oral
DRUG	Novel formulation	Cannabidiol 1000mg with lipid matrix, single dose, oral

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-08-26
• Completion: 2022-09-10
• First posted: 2021-09-02
• Last updated: 2024-02-06
• Results posted: 2024-02-06

Locations

1 site across 1 country: United Kingdom