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Trial registered on ANZCTR


Registration number
ACTRN12622000427774
Ethics application status
Approved
Date submitted
4/03/2022
Date registered
16/03/2022
Date last updated
29/08/2022
Date data sharing statement initially provided
16/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I Clinical Trial comparing Pharmacokinetics of EMD-RX5 Cannabidiol (CBD) capsules to Epidyolex CBD oil in Healthy Volunteers.
Scientific title
A randomised open label, two way crossover study comparing the Pharmacokinetic (PK) characteristics of one 150mg dose of EMD-RX5 Cannabidiol (CBD) capsules with one 150mg dose of Epidyolex CBD oil (100mg/mL) in healthy male and female volunteers.
Secondary ID [1] 306593 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psychological distress 325501 0
Condition category
Condition code
Mental Health 322876 322876 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will comprise 2 dosing periods of 12 participants. In the first period, 6 participants will be randomised to receive one dose of 150mg (3x50mg) EMD-RX5 CBD capsules. The other 6 participants will be randomised to receive one 150mg dose of Epidyolex oil. During this time PK and safety assessments will be made.

Following a washout period of 5-7 days, participants will return to the site for their second and final dosing period.

During the second dosing period, participants that received the Epidyolex oil in the first dosing period will receive EMD-RX5 CBD capsules and those that received the capsule in the first dosing period will receive the oil in the second dosing period. PK assessments will be taken up to 24 hours after the study drug administration in each dosing period. Adherence to the dosing regime will be monitored through one-on-one supervised dosing.
Intervention code [1] 323022 0
Treatment: Drugs
Comparator / control treatment
Epidyolex oil 100mg/mL is used as the comparator treatment for this study. A single 150mg dose of the oil will be administered.
Control group
Dose comparison

Outcomes
Primary outcome [1] 330657 0
Describe the pharmacokinetic parameters of EMD-RX5 CBD 50mg capsules after a once daily administration of 150mg
Timepoint [1] 330657 0
Plasma CBD PK parameters Cmax; Tmax; AUC0-24hr; AUCinf; T1/2 at the following times: pre-dose, 30 mins, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours post dose.
Secondary outcome [1] 407101 0
To evaluate the safety and tolerability of EMD-RX5 CBD 50mg capsules as assessed together by standard clinical and laboratory measures.

Examples of possible adverse events are: sleepiness, allergic reaction, injury to cells in the liver.

Clinical assessments will include: heart rate assessed by digital heart rate monitor, temperature assessed using infrared thermometer, blood pressure assessed by digital sphygmomanometer.

Laboratory measures (blood tests) will also be used to assess safety, including liver function tests, kidney function tests and full blood count tests (red blood cells, white blood cells and platelet cells).
Timepoint [1] 407101 0
Comparison of adverse events (AEs) during the treatment and post-treatment periods. Adverse events will be monitored daily from the day of the first dose through to 7 days after the final dose. Clinical measures will be assessed prior to the first dose, 24 hours post-first dose, prior to the second dose and 24 hours post-second dose.
Secondary outcome [2] 407100 0
To compare the pharmacokinetic parameters of EMD-RX5 CBD 50mg capsules after a single dose of 150mg to a single 150mg dose of CBD oil
Timepoint [2] 407100 0
Comparison of plasma CBD PK parameters Cmax; Tmax; AUC0-24hr; AUCinf; T1/2 of 150mg CBD capsules and 150mg CBD dose in oil at the following times: pre-dose, 30 mins, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours post dose.

Eligibility
Key inclusion criteria
- Healthy adults with BMI between 18-32kg/m2.
- Baseline full blood count and blood glucose test within normal limits
- Able to comply with study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnant or lactating females
- Medical condition that can cause cognitive deficits, or a clinically significant medical or surgical condition as determined by investigator
- Active Inflammatory disease
- Any cannabis use within 30 days
- Positive Drug or Alcohol test or recent or current history of drug or alcohol abuse
- Inability to consume high fat meal
- Baseline liver function tests more than 1.5 times upper limit of normal.
-Use of prescription medication within 2 weeks of dosing, or use of non-prescription medication (including herbal medicine or dietary supplements) within 1 week of dosing. Excludes oral contraceptives, paracetamol and multi-vitamin.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
The analysis of the relative bioavailability between the two different formulations (EMD-RX5 capsule as test and Epidyolex oil as reference) will be based on the dose-dependent plasma CBD parameters AUCinf, AUC0-24hr and Cmax. The natural log-transformed parameters will be analysed separately using a mixed effect model (data permitting) with the treatment group (formulation), sequence and period as fixed effects and subject nested within sequence as a random effect. The geometric means (exponentiated least squares means) and the associated 90% confidence intervals for each treatment group and the geometric mean ratio (exponentiated difference between EMD-RX5 capsule least-squares mean as test and Epidyolex oil least-squares mean as reference) and the associated 90% confidence interval will be presented. The geometric mean ratios and the associated confidence intervals will be expressed as percentages.

Bioequivalence will be concluded if the 2-sided 90% CI is completely contained within the interval (0.80, 1.25). The within- and between-subject variability of both treatments will also be estimated directly from the model for all AUC parameters and Cmax.

The analysis will also be repeated based on the dose-normalised AUCinf, AUC0-24hr and Cmax results.

Tmax will be analyzed nonparametrically using the Wilcoxon signed rank test.

Safety will be assessed by summarising adverse events and clinical laboratory tests. Adverse events will be listed and summarised by system organ class and preferred terms per treatment group. Vital signs and clinical laboratory tests will be tabulated and summarised per treatment group. Adverse event severity will be graded according to the CTCAE grading criteria (CTCAE version 5.0).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/04/2022
Date of last participant enrolment
Anticipated
31/03/2022
Actual
21/04/2022
Date of last data collection
Anticipated
13/04/2022
Actual
15/07/2022
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21871 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 36936 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 310924 0
Commercial sector/Industry
Name [1] 310924 0
Emyria Ltd
Country [1] 310924 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Emyria Ltd
Address
D2 661 Newcastle Street, Leederville WA 6007
Country
Australia
Secondary sponsor category [1] 312220 0
None
Name [1] 312220 0
Address [1] 312220 0
Country [1] 312220 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310484 0
Bellberry Ltd
Ethics committee address [1] 310484 0
Ethics committee country [1] 310484 0
Australia
Date submitted for ethics approval [1] 310484 0
02/02/2022
Approval date [1] 310484 0
03/03/2022
Ethics approval number [1] 310484 0

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

Contacts
Principal investigator
Name 117830 0
Dr Jonathan Newchurch
Address 117830 0
CMAX
Level 5, 18a North Terrace
Adelaide South Australia 5000
Country 117830 0
Australia
Phone 117830 0
+610870887900
Fax 117830 0
Email 117830 0
jonathan.newchurch@cmax.com.au
Contact person for public queries
Name 117831 0
Jonathan Newchurch
Address 117831 0
CMAX
Level 5, 18a North Terrace
Adelaide South Australia 5000
Country 117831 0
Australia
Phone 117831 0
+610870887900
Fax 117831 0
Email 117831 0
chloe.douglas@cmax.com.au
Contact person for scientific queries
Name 117832 0
Tracie Ernenwein
Address 117832 0
Emyria Ltd
D2 661 Newcastle Street
Leederville, Western Australia 6007
Country 117832 0
Australia
Phone 117832 0
+610865592800
Fax 117832 0
Email 117832 0
ternenwein@emyria.com

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


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.