Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- King's College London
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Total Drug Exposure. (Area Under the Curve to Infinity [AUC(Inf)]
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Novel lipid formulation then standard formulation
Intervention: Standard formulation (Drug)
Novel lipid formulation then standard formulation
Intervention: Novel formulation (Drug)
Standard formulation then lipid formulation
Intervention: Standard formulation (Drug)
Standard formulation then lipid formulation
Intervention: Novel formulation (Drug)
Outcomes
Primary Outcomes
Total Drug Exposure. (Area Under the Curve to Infinity [AUC(Inf)]
Time Frame: 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 Outcomes
- Plasma Half-life (t½)(0 - 48 hours)
- 48 Hour Drug Exposure (AUC0-48)(0 - 48 hours)
- Tmax(0 - 48 hours)
- Cmax(0 - 48 hours)
- Gastrointestinal Symptom Rating Scale (GSRS) - Total Score(The scale will be used pre-dose and at 24 and 48 hours post dose.)