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

• Status: Not yet recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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 encapsulation. 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: King's College London
• Treatments: Cannabidiol; Epidiolex

Criteria

Inclusion criteria

• Healthy volunteers

• Age 18-45

• Females of childbearing potential and males must be willing to use highly effective method of contraception (hormonal or barrier method of birth control; abstinence) throughout the duration of the study and for at least 4 weeks after

• Agreeing to fast 15 hours; 10pm-1pm on dosing days

• Capable of giving informed consent

• Written informed consent from participant

Exclusion criteria

• Any prescribed medication (apart from contraceptives)

• Use of any CBD products within the last six months

• Use of any over-the-counter medications or health supplements within the past 2 weeks

• BMI <18 or >30.0kg/m2

• History of alcohol or substance misuse disorder

• Smokes more than 10 cigarettes per day

• Use of any illicit substances within the last six months

• Pregnant or breastfeeding

• eGFR≤ 70 mls/min

• Any liver function or renal function test abnormality

• Urine drug screen positive for any substances

• Positive alcohol breath test

• Participant in any other clinical trial or experimental drug study in the past 3 months

• Known hypersensitivity to CBD and/or SEEK formulation excipients

• Participant is not able to swallow capsules