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

Phase 1

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Novel lipid formulation then standard formulation	Standard formulation	-
Standard formulation then lipid formulation	Standard formulation	-
Standard formulation then lipid formulation	Novel formulation	-
Novel lipid formulation then standard formulation	Novel formulation	-

Primary Outcome Measures

Name	Time	Method
Total Drug Exposure. (Area Under the Curve to Infinity [AUC(Inf)]	0 - 48 hours	Difference in AUC(inf) for a single dose of oral CBD between the novel and standard formulations in the fasting state.

Secondary Outcome Measures

Name	Time	Method
Plasma Half-life (t½)	0 - 48 hours	Half-life
48 Hour Drug Exposure (AUC0-48)	0 - 48 hours	Area under the concentration-time curve from time zero to 48hours
Tmax	0 - 48 hours	Time after administration of drug when maximum plasma concentration is reached
Cmax	0 - 48 hours	Maximum plasma concentration
Gastrointestinal Symptom Rating Scale (GSRS) - Total Score	The scale will be used pre-dose and at 24 and 48 hours post dose.	The GSRS was used to assess gastrointestinal symptoms over the past 24 hours only. It is a 15-item rating scale, where each item is assessed with a 7-point Likert scale, scored from 1 to 7, and with higher scores indicating more severe symptoms. The total score is the mean score across items (minimum score=1; maximum sore=7).