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Trial registered on ANZCTR


Registration number
ACTRN12622000961741
Ethics application status
Approved
Date submitted
4/07/2022
Date registered
7/07/2022
Date last updated
22/02/2023
Date data sharing statement initially provided
7/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase I, open label, randomised three-way cross over study to determine the safety and pharmacokinetics of CBD administered as a single oral dose to healthy volunteers
Scientific title
Phase I, open label, randomised three-way cross over study to determine the safety and pharmacokinetics of CBD administered as a single oral dose to healthy volunteers
Secondary ID [1] 307482 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 326905 0
Insomnia 326906 0
Condition category
Condition code
Oral and Gastrointestinal 324090 324090 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CBD Softgel Capsules 25 mg, single oral dose of 100 mg CBD (four capsules)
CBD Oral solution 100 mg/mL CBD, single oral dose of 1 mL
each participant will be randomly assigned to receive a single 100 mg oral dose of each intervention or the comparator (control treatment) total of three treatments. The washout period is seven days between each intervention.
Intervention code [1] 323935 0
Treatment: Drugs
Comparator / control treatment
Epidyolex (oral solution) CBD 100 mg/mL as a single oral dose of 1 mL
Control group
Active

Outcomes
Primary outcome [1] 331886 0
to measure total absorption of CBD using the concentration of blood samples
Timepoint [1] 331886 0
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 hours post-administration of each of the three treatments.
Secondary outcome [1] 411507 0
to measure the pharmacokinetics of CBD and its metabolites including AUC, T1/2, Tmax and Cmax using blood samples.
Timepoint [1] 411507 0
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 hours post-administration of each of the three treatments.
Secondary outcome [2] 411508 0
to assess the safety and tolerability of CBD softgel capsules assessed by regular monitoring of patients and ask if any unusual effects were experienced after their treatment at each visit.
the severity of adverse events is assessed as mild, moderate or severe. The number of adverse events as mild, moderate or severe will be collected and reported.
Timepoint [2] 411508 0
at the baseline visit and during the blood collection at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 hours post-administration of each of the three treatments.

Eligibility
Key inclusion criteria
• Male and females 18 – 30 years old
• BMI 18.5-30 kg/m2
• Otherwise healthy
• Able to provide informed consent
• Agree not to significantly change current diet/exercise
• Agree not to use over-the-counter drugs (except oral contraceptive pill) or other dietary supplements (including CBD) during the study period
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function Malignancy)*
• Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years
• Currently taking any prescription medication (other than for contraception e.g., oral contraceptive pill)
• Active smokers and nicotine or drug use (drug test will be administered)
• Chronic past and/or current alcohol use (>14 alcoholic drinks week)
• Allergic to any of the ingredients in active or placebo formula
• Diagnosed with serious mood disorders (such as depression and bipolar disorder)
• People suffering any neurological disorders such as MS
• Pregnant or lactating woman
• Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
• Participants who have participated in any other clinical trial during the past 1 month

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
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/07/2022
Actual
11/07/2022
Date of last participant enrolment
Anticipated
31/08/2022
Actual
31/08/2022
Date of last data collection
Anticipated
6/09/2022
Actual
6/09/2022
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 311760 0
Commercial sector/Industry
Name [1] 311760 0
Bod Limited
Country [1] 311760 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bod Limited
Address
Level 1, 377 New South Head Road
Double Bay NSW 2028
Country
Australia
Secondary sponsor category [1] 313243 0
None
Name [1] 313243 0
Address [1] 313243 0
Country [1] 313243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311203 0
The University of Queensland
Ethics committee address [1] 311203 0
The University of Queensland
Brisbane QLD 4072 Australia
Ethics committee country [1] 311203 0
Australia
Date submitted for ethics approval [1] 311203 0
Approval date [1] 311203 0
10/06/2022
Ethics approval number [1] 311203 0
2021/HE002830

Summary
Brief summary
The aim of this study is to assess the pharmacokinetics, safety and tolerability of two CBD formulations and test for bioequivalence to an existing commercial CBD product

HYPOTHESIS: CBD oil given as either a soft gel or oil solution will have a bioequivalent absorption to that of a commercial CBD oil (Epidylex).

DESIGN: A randomised, cross-over trial with 3 interventions. Product will be allocated on a 1:1:1 ratio.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120314 0
Dr David Briskey
Address 120314 0
University of Queensland
School of Human Movement and Nutrition Sciences
St Lucia QLD 4072
Country 120314 0
Australia
Phone 120314 0
+61 0421 784 077
Fax 120314 0
Email 120314 0
[email protected]
Contact person for public queries
Name 120315 0
David Briskey
Address 120315 0
University of Queensland
School of Human Movement and Nutrition Sciences
St Lucia QLD 4072
Country 120315 0
Australia
Phone 120315 0
+61 0421 784 077
Fax 120315 0
Email 120315 0
[email protected]
Contact person for scientific queries
Name 120316 0
David Briskey
Address 120316 0
University of Queensland
School of Human Movement and Nutrition Sciences
St Lucia QLD 4072
Country 120316 0
Australia
Phone 120316 0
+61 0421 784 077
Fax 120316 0
Email 120316 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
This is a commercial study and for IP protection, we have not yet decided to share the individual data.


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.