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Trial registered on ANZCTR
Registration number
ACTRN12620000462987
Ethics application status
Approved
Date submitted
17/03/2020
Date registered
9/04/2020
Date last updated
28/06/2021
Date data sharing statement initially provided
9/04/2020
Date results information initially provided
28/06/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
A Randomised, Open-label, Cross-over Study to Evaluate the Pharmacokinetics of a Single Dose of two Formulations of Orally Administered Tetrahydrocannabinol/Cannabidiol Combination in Fed Healthy Volunteers.
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Scientific title
A Phase I, Single-centre, Randomised, Open-label, Cross-over Study to Evaluate the Pharmacokinetics of a Single Dose of two Formulations of Orally Administered Tetrahydrocannabinol/Cannabidiol Combination in Fed Healthy Volunteers.
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Secondary ID [1]
300665
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pain
316462
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Condition category
Condition code
Anaesthesiology
314709
314709
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
316993
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Treatment: Drugs
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Comparator / control treatment
Arm 1: THC/CBD 10 mg/mL: 10 mg/mL oil: 0.25 mL administered orally with cross-over to ACNV201
Arm 2: THC/CBD 10 mg/mL: 10 mg oil/mL: 1 mL administered orally with cross-over to ACNV202
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Control group
Active
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Outcomes
Primary outcome [1]
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Assessment of the pharmacokinetics of THC for subjects receiving a single dose of orally administered THC/CBD (1:1 ratio) combination product.
The following PK parameters will be assessed: AUC, Cmax and Tmax.
A plasma assay will be used.
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Assessment method [1]
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Timepoint [1]
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Blood samples for PK analysis will be taken within 10 minutes prior to dosing and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 9, 12, 16, 24, 32, 40 and 48 hours after dosing on Day 1 (Treatment Period 1) and then again on Day 1 (Treatment Period 2), prior to and after dosing, at the same time points.
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Primary outcome [2]
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Assessment of the pharmacokinetics of CBD for subjects receiving a single dose of orally administered THC/CBD (1:1 ratio) combination product.
The following PK parameters will be assessed: AUC, Cmax and Tmax.
A plasma assay will be used.
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Assessment method [2]
323290
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Timepoint [2]
323290
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Blood samples for PK analysis will be taken within 10 minutes prior to dosing and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 9, 12, 16, 24, 32, 40 and 48 hours after dosing on Day 1 (Treatment Period 1) and then again on Day 1 (Treatment Period 2), prior to and after dosing, at the same time points.
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Primary outcome [3]
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Assessment of the pharmacokinetics of THC's major metabolite 11-hydroxy-THC for subjects receiving a single dose of orally administered THC/CBD (1:1 ratio) combination product.
The following PK parameters will be assessed: AUC, Cmax and Tmax.
A plasma assay will be used.
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Assessment method [3]
323360
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Timepoint [3]
323360
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Blood samples for PK analysis will be taken within 10 minutes prior to dosing and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 9, 12, 16, 24, 32, 40 and 48 hours after dosing on Day 1 (Treatment Period 1) and then again on Day 1 (Treatment Period 2), prior to and after dosing, at the same time points.
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Secondary outcome [1]
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Evaluate the safety of a single dose of orally administered THC/CBD (1:1 ratio) combination product when administered in the fed state to healthy volunteers.
Outcome is assessed by frequency and type of adverse events, physical examination, vital signs, ECG data, and clinical laboratory tests.
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Assessment method [1]
380616
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Timepoint [1]
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28 days post first dose.
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Pharmacokinetics
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
10/04/2020
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Actual
7/04/2020
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Date of last participant enrolment
Anticipated
22/04/2020
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Actual
27/05/2020
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Date of last data collection
Anticipated
21/05/2020
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Actual
27/05/2020
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Sample size
Target
28
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Accrual to date
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Final
28
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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AusCann Group Holdings Ltd
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Address [1]
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57 Shenton Avenue
Joondalup
WA 6027
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Country [1]
305088
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
AusCann Group Holdings Ltd
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Address
57 Shenton Avenue
Joondalup
WA 6027
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
305465
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Country [1]
305465
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305480
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
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55 Commercial Rd, Melbourne VIC 3004
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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24/02/2020
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Approval date [1]
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30/03/2020
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Ethics approval number [1]
305480
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Ingrid Hooper
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Address
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Centre for Clinical Studies
Level 5, Burnet Tower
89 Commercial Road
Melbourne 3004 VIC
Australia
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Country
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Australia
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Phone
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+61385939817
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Ingrid Hooper
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Address
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Centre for Clinical Studies
Level 5, Burnet Tower
89 Commercial Road
Melbourne 3004 VIC
Australia
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Country
100511
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Australia
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Phone
100511
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+61 1800 243 733
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Fax
100511
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Email
100511
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[email protected]
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Contact person for scientific queries
Name
100512
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Dr Ingrid Hooper
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Address
100512
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Centre for Clinical Studies
Level 5, Burnet Tower
89 Commercial Road
Melbourne 3004 VIC
Australia
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Country
100512
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Australia
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Phone
100512
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+61 1800 243 733
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Fax
100512
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Email
100512
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Data generated is commercially sensitive.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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