None listed
Conditions
Brief summary
This Phase I study will be the first evaluation of the pharmacokinetics of the THC/CBD products from AusCann Group Holdings Ltd, specifically their 2.5 mg:2.5 mg and 10 mg: 10 mg capsule presentations, when administered to healthy volunteers. The pharmacokinetic data will aid clinical prescribing decisions for use under the existing regulatory pathways for medicinal cannabis, namely the Authorised Prescriber and Special Access Scheme and future clinical trials.
Interventions
Arm 1: ACNV201: 2.5 mg: 2.5 mg THC:CBD; one capsule administered orally with cross-over to oil comparator
Arm 2: ACNV202: 10 mg: 10 mg THC:CBD; one capsule administered orally with cross-over to oil comparator
There will be a washout period of 14 days between treatment periods.
Subjects will receive a standardised meal prior to drug administration. This will be the FDA recommended high fat breakfast, i.e. 2 rashers of bacon, 2 eggs fried in butter, 2 hashbrowns, 2 slices of white taste with butt
Arm 1: ACNV201: 2.5 mg: 2.5 mg THC:CBD; one capsule administered orally with cross-over to oil comparator Arm 2: ACNV202: 10 mg: 10 mg THC:CBD; one capsule administered orally with cross-over to oil comparator There will be a washout period of 14 days between treatment periods. Subjects will receive a standardised meal prior to drug administration. This will be the FDA recommended high fat breakfast, i.e. 2 rashers of bacon, 2 eggs fried in butter, 2 hashbrowns, 2 slices of white taste with butter and 240 mL of whole fat milk. An equivalent vegetarian/vegan breakfast may be used in place of the standard high fat breakfast, provided that the breakfast is identical in terms of fat content and calories. Dosing will be administered under supervision at the site.
Sponsors
AusCann Group Holdings Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male and female subjects between the ages of 18 and 55 years, inclusive, at the time of screening. 2. Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive. 3. Good general health, as determined by the Principal Investigator or delegate based on a medical evaluation. 4. Subject has a minimum of 2 lifetime exposures to THC-containing cannabis products.
Exclusion criteria
1. Clinically significant haematological, renal, endocrine, pulmonary, cardiovascular, hepatic, neurologic, or allergic disease. 2. Evidence or history of seizures, excluding childhood febrile convulsions. 3. Current or medical history of: - Depression, schizophrenia, psychosis, bipolar disorder or other psychiatric disorders. Subjects with depression are permitted if they haven’t had symptoms or taken medication/treatment within the past 6 months and have no history of suicide attempts or panic attacks. - Suicide attempts or suicidal ideation. 4. Subject has used cannabis or products containing cannabinoids within the 3 months prior to screening, has any history of drug abuse, or has a positive DOA test at screening. 5. Subject has any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis at screening.
Outcome results
None listed