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Trial registered on ANZCTR


Registration number
ACTRN12620000891921
Ethics application status
Approved
Date submitted
3/07/2020
Date registered
10/09/2020
Date last updated
29/06/2021
Date data sharing statement initially provided
10/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of the safety and tolerability of single doses of wafers containing cannabidiol (CBD) that dissolve under the tongue compared to CBD oil that is swallowed in healthy volunteers.
Scientific title
A phase I, open label, two-way crossover study to determine the pharmacokinetic effects, safety, and tolerability of single doses of sublingual cannabidiol wafers vs. cannabidiol oil in healthy volunteers
Secondary ID [1] 301685 0
XAT-001
Universal Trial Number (UTN)
U1111-1254-6913
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 318133 0
Insomnia 319013 0
Pain 319014 0
Tremor 319015 0
Inflammatory Conditions 319016 0
Condition category
Condition code
Alternative and Complementary Medicine 316157 316157 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A research clinic staff member will administer a single dose of 25mg cannabidiol wafer via sublingual route to each participant and will observe that the participant remains still to allow the wafer to dissolve. There will be a minimum of a 4 day washout before the second treatment is administered.
Intervention code [1] 317995 0
Treatment: Drugs
Comparator / control treatment
A research clinic staff member will administer a single dose of Cannabidiol oil 25mg via syringe into the participant's mouth and the participant will be instructed to swallow the oil.
Control group
Active

Outcomes
Primary outcome [1] 324341 0
To determine and compare the pharmacokinetics of a single dose of 25mg cannabidiol sublingual wafer vs. a single dose of 25mg cannabidiol oil. Blood samples will be obtained for examination of PK parameters such as AUC, Cmax, and AUMC.
Timepoint [1] 324341 0
Blood samples will be collected pre-dose, and then at 5, 10, 15, 30, 45 and 60 minutes, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours post-dose.
Secondary outcome [1] 384381 0
To assess the safety and tolerability of a single dose of 25mg cannabidiol sublingual wafer and a single dose of 25mg cannabidiol oil. Safety and tolerability will be assessed by physical exam, vital signs, ECG and collection of adverse events (e.g. sleepiness, poor quality sleep, or decreased appetite) that occur following the first dose of study medication through the end of the study.
Timepoint [1] 384381 0
Full physical exam will be conducted at screening and a brief physical exam prior to dosing for Period 1. Brief physical exam may be performed as needed during the study if indicated by the presence of an adverse event. Vital signs will be measured at pre-dose (within 2 hours of dosing), and at 1, 3, 6, and 10 hours post- dose. ECG will be conducted pre-dose and at 10 hours post-dose. Collection of adverse events will commence at time of initial dose of study medication and will continue through the follow-up call, 3 days after discharge from period 2.

Eligibility
Key inclusion criteria
Healthy volunteer with no major medical conditions and a BMI between 19.0 to 25.0 kg/m2 inclusive. Females must be using acceptable birth control and not planning to become pregnant.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Must not have used cannabinoid based medicine in the last 6 months. No blood donation within the past month. Must not consume grapefruit juice within 48 hours of study visits.

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/09/2020
Actual
11/09/2020
Date of last participant enrolment
Anticipated
Actual
14/11/2020
Date of last data collection
Anticipated
Actual
8/12/2020
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 306122 0
Commercial sector/Industry
Name [1] 306122 0
iX Biopharma Pty Ltd
Country [1] 306122 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
iX Biopharma Pty Ltd
Address
24 Augusta Street
Willetton, WA 6155
Australia
Country
Australia
Secondary sponsor category [1] 306591 0
None
Name [1] 306591 0
None
Address [1] 306591 0
None
Country [1] 306591 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306340 0
Bellberry
Ethics committee address [1] 306340 0
Ethics committee country [1] 306340 0
Australia
Date submitted for ethics approval [1] 306340 0
07/08/2020
Approval date [1] 306340 0
04/09/2020
Ethics approval number [1] 306340 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103546 0
Dr Ana Sun
Address 103546 0
Affinity Clinical Research Services Pty Ltd
16/95 Monash Ave
NEDLANDS WA 6009
Country 103546 0
Australia
Phone 103546 0
+61 0474769593
Fax 103546 0
Email 103546 0
sunala2020@gmail.com
Contact person for public queries
Name 103547 0
Krystyne Hiscock
Address 103547 0
Affinity Clinical Research Services Pty Ltd
16/95 Monash Ave
NEDLANDS WA 6009
Country 103547 0
Australia
Phone 103547 0
+61 0474769593
Fax 103547 0
Email 103547 0
pm1@affinityresearch.com.au
Contact person for scientific queries
Name 103548 0
Janakan Krishnarajah
Address 103548 0
iX Biopharma Pty Ltd
24 Augusta Street
Willetton, WA 6155
Australia
Country 103548 0
Australia
Phone 103548 0
+61 412 999 004
Fax 103548 0
Email 103548 0
j.krishnarajah@ixbiopharma.com

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


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
SourceTitleYear of PublicationDOI
EmbaseCannabidiol in clinical and preclinical anxiety research. A systematic review into concentration-effect relations using the IB-de-risk tool.2022https://dx.doi.org/10.1177/02698811221124792
N.B. These documents automatically identified may not have been verified by the study sponsor.