None listed
Conditions
Brief summary
This is a single blinded randomised placebo-controlled study. This study will be performed in healthy subjects to determine the pharmacokinetic, safety and tolerability characteristics of a novel Cannabidiol formulation in the form of an oro-buccal spray. The drug contains 6 mg CBD and <0.3 mg other cannabinoids (including THC)/0.3 mL in 2 actuations of the pump (equals 1 dose).
Interventions
To evaluate the pharmacokinetic, safety and tolerability characteristics of a nanocelled (micellised) cannabis extract (Cannabidiol 'CBD' primarily) from the whole plant (Cannabis sativa L.) administered as an oro-buccal spray (in a particle size of 0.05–0.2 microns) to 16 healthy volunteers when compared to a placebo. The active treatment contains 6 mg CBD and <0.3 mg other cannabinoids (including THC)/0.3 mL in 2 actuations of the pump (equals 1 dose).
On study Day 1 (morning), a pre-dose bl
To evaluate the pharmacokinetic, safety and tolerability characteristics of a nanocelled (micellised) cannabis extract (Cannabidiol 'CBD' primarily) from the whole plant (Cannabis sativa L.) administered as an oro-buccal spray (in a particle size of 0.05–0.2 microns) to 16 healthy volunteers when compared to a placebo. The active treatment contains 6 mg CBD and <0.3 mg other cannabinoids (including THC)/0.3 mL in 2 actuations of the pump (equals 1 dose). On study Day 1 (morning), a pre-dose blood sample will be collected from the participants while fasting, participants to be randomised. Subsequently, 2 sprays of the IP will be administered at 0 minutes. Additional blood samples will be collected at the following time points: 30, 60, 90, 120, 180, 240, 360, 420 minutes (7 hours), 12 hours and at 24 hours. On study Day 2, after the 24 hours blood sample has been collected, 6 sprays of the IP will be administered to the participants at 0 minutes. Blood samples will be collected at the following time points: 30, 60, 90, 120, 180, 240, 360, 420 minutes (7 hours), 12 hours and at 24 hours. Participants will be discharged from the facility on the morning of study Day 3. Allocation: randomised. Treatment Endpoint classification: none. Intervention Model: oro-buccal administration. Masking: single-blinded. Primary Purpose: pharmacokinetic, safety and tolerability.
Sponsors
Medlab Clinical
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1) Participants greater or equal to 18 years of age at time of entry on the study; 2) Cognitive ability to understand informed consent process and to give and sign informed consent to the experimental treatment; 3) Participants agree to undergo insertion of an indwelling cannula once for approximately 48 hours with multiple blood draws; 4) Participants agree to adhere to the study protocol; 5) No history of illicit drug use (e.g., including but not limited to natural or synthetic cannabinoid compounds); 6) No history of any chronic diseases; 7) Agree to not driving a car for at least 7 days post administration of the final dose of the IP on Day 2.
Exclusion criteria
1) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs; 2) Current or previous allergies or allergic responses to herbal medicines of any kind; 3) Active substance abuse (alcohol or drug dependency); 4) The current use of any illicit drugs (e.g., cannabis in any form); 5) Pregnant or nursing an infant; 6) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant; 7) Elevated liver enzymes 2x normal limits; 8) The current use of any dietary and herbal supplements; 9) The current use of any over-the-counter or prescription medications.
Outcome results
None listed