Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation (CLIP)
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|ClinicalTrials.gov Identifier: NCT05032807|
Recruitment Status : Completed
First Posted : September 2, 2021
Last Update Posted : October 4, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Absorption; Chemicals||Drug: Cannabidiol standard formulation Drug: Cannabidiol novel formulation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation|
|Actual Study Start Date :||July 1, 2022|
|Actual Primary Completion Date :||August 26, 2022|
|Actual Study Completion Date :||September 10, 2022|
|Experimental: Novel lipid formulation cannabidiol||
Drug: Cannabidiol novel formulation
Cannabidiol 1000mg with lipid encapsulation, single dose, oral
|Active Comparator: Standard formulation cannabidiol||
Drug: Cannabidiol standard formulation
Cannabidiol 1000mg standard formulation, single dose, oral
- 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.
- Cmax [ Time Frame: 0 - 48 hours ]Maximum plasma concentration
- Tmax [ Time Frame: 0 - 48 hours ]Time after administration of drug when maximum plasma concentration is reached
- Plasma half-life (t½) [ Time Frame: 0 - 48 hours ]
- 48 hour drug exposure (AUC0-48) [ Time Frame: 0 - 48 hours ]Area under the concentration-time curve from time zero to 48hours
- Drug Effects Questionnaire (DEQ-5) [ Time Frame: pre dose and at 1, 2, 4, 8, 24 and 48hrs post-dose. ]The DEQ-5 is questionnaire with five items, for example ''Do you feel a drug effect, right now?' with the response anchors 'Not at all' and 'Extremely'.
- Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: The scale will be used pre-dose and at 24 and 48 hours post dose. ]The GSRS is a 15-item rating scale which assesses five symptom clusters: reflux, abdominal pain, indigestion, diarrhoea and constipation. Each item is assessed with a 7-point Likert scale. The standard recall period for the scale is 7 days; this will be amended so that it assesses past 24 hours only.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05032807
|King's College London|
|London, United Kingdom, SE5 8AB|