Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001011774
Ethics application status
Approved
Date submitted
12/07/2022
Date registered
19/07/2022
Date last updated
28/02/2023
Date data sharing statement initially provided
19/07/2022
Date results information initially provided
28/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pharmacokinetic study on Ananda Hemp Oil in healthy volunteers
Scientific title
A Pharmacokinetic study on Ananda Hemp Oil in healthy volunteers
Secondary ID [1] 307536 0
None
Universal Trial Number (UTN)
Trial acronym
AnandaPK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disturbance 326969 0
Condition category
Condition code
Neurological 324150 324150 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ananda Hemp Soft Gel CBD 98% Broad Spectrum (no THC)
The soft gel product will contain hemp seed oil as the carrier and 0.5mL of liquid encapsulated into a gelatin/glycerin soft capsule. The active ingredient is hemp-derived, cannabis sativa extract. Each soft capsule contains 15mg of CBD, with trace amounts of minor cannabinoids. CBD will make up >98% of the total cannabinoids in the soft capsule. Non-active ingredients include hemp seed oil, glycerin, and gelatin. The product has a shelf-life of 24 months and should be stored at room temperature. The product will be packaged in a white, opaque HDPE pill packer bottles with a 0.5g desiccant and a white, heat-induction cap and perforated neck band.

Dose is 15mg (1 capsule) oral administration once only. The soft gel capsule will be given first for the 24 hour testing with a 14-20 day wash out before administration of the comparator treatment.

Administration of the interventions will be conducted under supervised administration by trial nurse.
Intervention code [1] 323996 0
Treatment: Other
Comparator / control treatment
Ananda Hemp Tincture CBD 98% Broad Spectrum (no THC)

The other active product is the same content as the soft gels but is in a liquid in a brown glass bottle. Each different form of administration is being conducted on the same people to ascertain if the PK in blood and urine is the same for a soft gel capsule compared to a liquid tincture.

After a 14-20 day wash out period, the same person will receive 15mg (0.75ml) oral administration once only on the day of testing.

Monitoring of adherence will occur via supervised administration by the trial nurse.
Control group
Active

Outcomes
Primary outcome [1] 331964 0
To examine the 24-hour pharmacokinetics of Ananda Hemp CBD (98%) soft gel capsules at a dose of 15mg once.

The outcomes will be based AUC, Cmax curve on both blood (plasma) and urine samples.
Timepoint [1] 331964 0
Blood and urine samples will be collected at 0,1,2,3,4,5,6,8,and 24 hours post oral administration.
Primary outcome [2] 332019 0
To examine the 24-hour pharmacokinetics of Ananda Hemp CBD (98%) tincture at a dose of 15mg once.

The outcomes will be based AUC, Cmax curve on both blood (plasma) and urine samples.
Timepoint [2] 332019 0
The outcomes will be measured at 0,1,2,3,4,5,6,8,24 hours post oral administration
Secondary outcome [1] 411741 0
To assess the absorption of cannabinoids in blood after a single oral dose of CBD 15mg over nine-time points in 24 hours.
Timepoint [1] 411741 0
Two 24-hour time points with blood taken at 0, 1, 2, 3, 4, 5, 6, 8, 24 hours post each oral administration of the investigator product
Secondary outcome [2] 411742 0
To assess the excretion of cannabinoids in urine over nine-time points in 24 hours after a single oral administration of CBD 15mg. .
Timepoint [2] 411742 0
Two 24-hour time points will have urine taken at 0,1,2,3,4,5,6,8, and 24 hours post each oral administration. of the CBD 15mg.
Secondary outcome [3] 411930 0
To assess the absorption of metabolites of CBD in blood over nine-time points in 24 hours after a single oral administration of CBD 15mg. .
Timepoint [3] 411930 0
Blood will be taken at 0,1,2,3,4,5,6,8, and 24 hours post oral administration of CBD 15mg.
Secondary outcome [4] 411931 0
To assess the excretion of metabolites of CBD in urine over nine-time points in 24 hours after oral administration of CBD 15mg. .
Timepoint [4] 411931 0
Urine will be collected at 0,1,2,3,4,5,6,8, and 24 hours post oral administration of CBD 15mg. .
Secondary outcome [5] 411932 0
To assess the safety of oral administration of CBD 15mg via side effect profile using a 5 point Likert scale.
The known side effects of CBD that will be assessed is dry mouth, dizziness, nausea, light-headedness, fatigue, decreased appetite, drowsiness and fever.
Timepoint [5] 411932 0
The timepoints of side effect collection will occur post administration at 1,2,3,4,5,6,8, and 24 hours. In addition, any side effects in the week (7 days) post administration will also be collected.

Eligibility
Key inclusion criteria
- Adults aged 18 to 65 years old
- BMI between 18.5 to 35
- Considered to be generally healthy by the consenting medical practitioner
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnant or breast-feeding women
- Current and clinically significant acute disease as determined by the PI
- Current diagnosis of any clinically significant chronic disease
- Severe mental illness or difficulty communicating
- Recreational drug use (positive Drugs of Abuse (DOA) test). If Screening DOA test is positive to THC ONLY, participants will have the opportunity for 1 x re-test 2 weeks after the positive result.
- Elevated liver enzymes or liver damage (greater than 1.5 Upper Limit of Normal) on screening pathology
- History of cardiac arrest or any cardiovascular disease
- Screening eGFR less than 59
- Current use of any other medication/supplement that has a known interaction with CBD
- CBD or cannabis use within the 2 weeks prior to the Screening Visit.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
All data will be analysed via SPSS 27.0. Analyses will be conducted on the per-protocol based on participants completing both PK1 and PK2 to at least Day 15. Descriptive statistics will summarise data as either means (absolute, relative or percentage change) with standard deviations or medians with interquartile range as appropriate for the data. The safety data will be summarised via descriptive statistics.
The traditional method of PK data analysis uses a two-stage approach. The first stage of this approach involves the estimation of PK parameters through nonlinear regression using an individual's dense concentration-time data (data from each time point). Individual parameter estimates obtained during the first stage serve as input data for the second-stage calculation of descriptive summary statistics on the sample, typically, mean parameter estimates, variance, and covariance of the individual parameter estimates. Analysis of dependencies between parameters and covariates using classical statistical approaches (linear stepwise regression, covariance analysis, cluster analysis) can be included in the second stage.

The two-stage approach, when applicable, can yield adequate estimates of population characteristics. Mean estimates of parameters are usually unbiased, but the random effects (variance and covariance) are likely to be overestimated in all realistic situations. Refinements have been proposed (e.g., global two-stage approach) to improve the two-stage approach through bias correction for the random effect’s covariance and differential weighting of individual data according to the data's quality and quantity.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2022
Actual
8/08/2022
Date of last participant enrolment
Anticipated
19/09/2022
Actual
22/09/2022
Date of last data collection
Anticipated
21/10/2022
Actual
20/10/2022
Sample size
Target
25
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22784 0
Griffith University Clinical Trials Unit - Southport
Recruitment postcode(s) [1] 38066 0
4215 - Southport
Recruitment postcode(s) [2] 38068 0
4216 - Runaway Bay
Recruitment postcode(s) [3] 38069 0
4217 - Benowa
Recruitment postcode(s) [4] 38067 0
4222 - Griffith University

Funding & Sponsors
Funding source category [1] 311811 0
Commercial sector/Industry
Name [1] 311811 0
Ecofibre Pty Ltd
Country [1] 311811 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
1 Military road, Lismore NSW 2480
Country
Australia
Secondary sponsor category [1] 313286 0
None
Name [1] 313286 0
None
Address [1] 313286 0
None
Country [1] 313286 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311256 0
Southern Cross University HREC
Ethics committee address [1] 311256 0
1 Military road, Lismore NSW 2480
Ethics committee country [1] 311256 0
Australia
Date submitted for ethics approval [1] 311256 0
24/06/2022
Approval date [1] 311256 0
13/07/2022
Ethics approval number [1] 311256 0
2022/099
Ethics committee name [2] 311257 0
Griffith University HREC
Ethics committee address [2] 311257 0
1 Parklands Drive, Parklands, Qld 4215
Ethics committee country [2] 311257 0
Australia
Date submitted for ethics approval [2] 311257 0
18/07/2022
Approval date [2] 311257 0
Ethics approval number [2] 311257 0

Summary
Brief summary
The study is a pharmacokinetic study on 20 volunteers assessing blood and urine pharmacokinetics and excretion for a 98% CBD product with no THC. The same product is available in a soft gel capsule and a liquid oil. Twenty participants will undergo 24 hour testing for each drug around 2-3 weeks apart. Blood and urine will be taken at 0,1,2,3,4,5,6,8 and 24 hours. They do not have to stay overnight but do need to come back to the clinic for their 24 hour testing.
Trial website
https://www.scu.edu.au/national-centre-for-naturopathic-medicine/research/clinical-trials/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120478 0
Dr Sachin Deshmukh
Address 120478 0
Griffith University Clinical Trials Unit
Level 4, Griffith Health Centre (G40), Gold Coast campus, Cnr Parklands Drive and Olsen Avenue, Southport QLD 4215
Country 120478 0
Australia
Phone 120478 0
+61 7 5678 0929
Fax 120478 0
Email 120478 0
s.deshmukh@griffith.edu.au
Contact person for public queries
Name 120479 0
Dr Janet Schloss
Address 120479 0
Southern Cross University
1 Military Road
Lismore NSw 2480
Country 120479 0
Australia
Phone 120479 0
+61 0436 101 306
Fax 120479 0
Email 120479 0
janet.schloss@scu.edu.au
Contact person for scientific queries
Name 120480 0
Dr Janet Schloss
Address 120480 0
Southern Cross University
1 Military Road
Lismore NSw 2480
Country 120480 0
Australia
Phone 120480 0
+61 0436 101 306
Fax 120480 0
Email 120480 0
janet.schloss@scu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual patient data will not be made available as the group statistics to develop the curve for the PK of the drugs.


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.