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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
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.
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.
Secondary ID [1] 300665 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 316462 0
Condition category
Condition code
Anaesthesiology 314709 314709 0 0
Pain management

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 316993 0
Treatment: Drugs
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
Control group
Active

Outcomes
Primary outcome [1] 323050 0
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.
Timepoint [1] 323050 0
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.
Primary outcome [2] 323290 0
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.
Timepoint [2] 323290 0
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.
Primary outcome [3] 323360 0
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.
Timepoint [3] 323360 0
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.
Secondary outcome [1] 380616 0
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.
Timepoint [1] 380616 0
28 days post first dose.

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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2020
Actual
7/04/2020
Date of last participant enrolment
Anticipated
22/04/2020
Actual
27/05/2020
Date of last data collection
Anticipated
21/05/2020
Actual
27/05/2020
Sample size
Target
28
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305088 0
Commercial sector/Industry
Name [1] 305088 0
AusCann Group Holdings Ltd
Country [1] 305088 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
AusCann Group Holdings Ltd
Address
57 Shenton Avenue
Joondalup
WA 6027
Country
Australia
Secondary sponsor category [1] 305465 0
None
Name [1] 305465 0
Address [1] 305465 0
Country [1] 305465 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305480 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 305480 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 305480 0
Australia
Date submitted for ethics approval [1] 305480 0
24/02/2020
Approval date [1] 305480 0
30/03/2020
Ethics approval number [1] 305480 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100510 0
Dr Ingrid Hooper
Address 100510 0
Centre for Clinical Studies
Level 5, Burnet Tower
89 Commercial Road
Melbourne 3004 VIC
Australia
Country 100510 0
Australia
Phone 100510 0
+61385939817
Fax 100510 0
Email 100510 0
[email protected]
Contact person for public queries
Name 100511 0
Ingrid Hooper
Address 100511 0
Centre for Clinical Studies
Level 5, Burnet Tower
89 Commercial Road
Melbourne 3004 VIC
Australia
Country 100511 0
Australia
Phone 100511 0
+61 1800 243 733
Fax 100511 0
Email 100511 0
[email protected]
Contact person for scientific queries
Name 100512 0
Ingrid Hooper
Address 100512 0
Centre for Clinical Studies
Level 5, Burnet Tower
89 Commercial Road
Melbourne 3004 VIC
Australia
Country 100512 0
Australia
Phone 100512 0
+61 1800 243 733
Fax 100512 0
Email 100512 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data generated is commercially sensitive.


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.