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Trial registered on ANZCTR


Registration number
ACTRN12617001491358
Ethics application status
Approved
Date submitted
17/10/2017
Date registered
23/10/2017
Date last updated
29/01/2020
Date data sharing statement initially provided
8/11/2018
Date results information initially provided
29/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The buccal administration of a NanoCelle™ Cannabidiol formulation to healthy volunteers: a pharmacokinetic, safety and tolerability exploratory pilot study.
Scientific title
The buccal administration of a NanoCelle™ Cannabidiol formulation to healthy volunteers: a pharmacokinetic, safety and tolerability exploratory pilot study.
Secondary ID [1] 289891 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The Investigational Product may be indicated for anxiety 299864 0
The Investigational Product may be indicated for mood symptoms 305170 0
The Investigational Product may be indicated for insomnia 305171 0
The Investigational Product may be indicated for the treatment of inflammatory pain 305172 0
Condition category
Condition code
Alternative and Complementary Medicine 299770 299770 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To evaluate the pharmacokinetic, safety and tolerability characteristics of a nanocelled (micellised) cannabis extract (Cannabidiol 'CBD' primarily) from the whole plant (Cannabis sativa L.) administered as an oro-buccal spray (in a particle size of 0.05–0.2 microns) to 16 healthy volunteers when compared to a placebo. The active treatment contains 6 mg CBD and <0.3 mg other cannabinoids (including THC)/0.3 mL in 2 actuations of the pump (equals 1 dose).

On study Day 1 (morning), a pre-dose blood sample will be collected from the participants while fasting, participants to be randomised. Subsequently, 2 sprays of the IP will be administered at 0 minutes. Additional blood samples will be collected at the following time points: 30, 60, 90, 120, 180, 240, 360, 420 minutes (7 hours), 12 hours and at 24 hours. On study Day 2, after the 24 hours blood sample has been collected, 6 sprays of the IP will be administered to the participants at 0 minutes. Blood samples will be collected at the following time points: 30, 60, 90, 120, 180, 240, 360, 420 minutes (7 hours), 12 hours and at 24 hours. Participants will be discharged from the facility on the morning of study Day 3.

Allocation: randomised. Treatment Endpoint classification: none. Intervention Model: oro-buccal administration. Masking: single-blinded. Primary Purpose: pharmacokinetic, safety and tolerability.

Intervention code [1] 295586 0
Treatment: Drugs
Comparator / control treatment
Placebo controlled. Composition: Natural and Artificial Flavour, Propylene Glycol (oral spray delivery).
Control group
Placebo

Outcomes
Primary outcome [1] 299230 0
Composite outcome, safety and tolerability: - Demographic data - Medical History - Concomitant medications - ECG - Vital Signs - Blood pathology: FBC, Urea, lipids, electrolytes and creatinine and LFTs - Urine THC testing, Adverse events monitoring and recording.
Timepoint [1] 299230 0
- Demographic data: screening
- Medical History: screening
- Concomitant medications: throughout study
- ECG: baseline and 24 hours
- Vital Signs: throughout study
- Blood pathology: FBC, Urea, lipids, electrolytes and creatinine and LFTs: screening and 24 hours
- Urine THC testing: screening and 24 hours
- Adverse events monitoring and recording: throughout study
Secondary outcome [1] 339838 0
Pharmacokinetic properties of the Investigational Product:
- Drug absorption, distribution, metabolism and excretion time.
- Drug Half-life and peak concentration
Timepoint [1] 339838 0
Blood draws on Day 1: at baseline (0), 15, 30, 60, 90, 120, 180, 240, 360, and 420 min and 24 hours (via intravenous cannula inserted in a vein in the arm or venepuncture) post administration of the IP. Day 2: 30, 60, 90, 120, 180, 240, 360, 420 minutes (7 hours), 12 hours and at 24 hours post administration of the IP

Eligibility
Key inclusion criteria
1) Participants greater or equal to 18 years of age at time of entry on the study;
2) Cognitive ability to understand informed consent process and to give and sign informed consent to the experimental treatment;
3) Participants agree to undergo insertion of an indwelling cannula once for approximately 48 hours with multiple blood draws;
4) Participants agree to adhere to the study protocol;
5) No history of illicit drug use (e.g., including but not limited to natural or synthetic cannabinoid compounds);
6) No history of any chronic diseases;
7) Agree to not driving a car for at least 7 days post administration of the final dose of the IP on Day 2.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs;
2) Current or previous allergies or allergic responses to herbal medicines of any kind;
3) Active substance abuse (alcohol or drug dependency);
4) The current use of any illicit drugs (e.g., cannabis in any form);
5) Pregnant or nursing an infant;
6) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant;
7) Elevated liver enzymes 2x normal limits;
8) The current use of any dietary and herbal supplements;
9) The current use of any over-the-counter or prescription medications.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11712 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 23794 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 294271 0
Commercial sector/Industry
Name [1] 294271 0
Medlab Clinical
Address [1] 294271 0
66 McCauley Street, Alexandria, New South Wales 2015
Country [1] 294271 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical
Address
66 McCauley Street, Alexandria, New South Wales, 2015
Country
Australia
Secondary sponsor category [1] 293106 0
None
Name [1] 293106 0
Address [1] 293106 0
Country [1] 293106 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295699 0
National Institute of Integrative Medicine
Ethics committee address [1] 295699 0
11-23 Burwood Road, Hawthorn, Melbourne VIC 3122
Ethics committee country [1] 295699 0
Australia
Date submitted for ethics approval [1] 295699 0
17/07/2018
Approval date [1] 295699 0
31/08/2018
Ethics approval number [1] 295699 0
0049E_2018

Summary
Brief summary
This is a single blinded randomised placebo-controlled study. This study will be performed in healthy subjects to determine the pharmacokinetic, safety and tolerability characteristics of a novel Cannabidiol formulation in the form of an oro-buccal spray. The drug contains 6 mg CBD and <0.3 mg other cannabinoids (including THC)/0.3 mL in 2 actuations of the pump (equals 1 dose).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68122 0
Dr James Kuo
Address 68122 0
Level 5, Bright Building, Corner High and Avoca Street, Randwick NSW 2031, Australia.
Country 68122 0
Australia
Phone 68122 0
+61 2 9382 5800
Fax 68122 0
Email 68122 0
james.kuo@scientiaclinicalresearch.com.au
Contact person for public queries
Name 68123 0
Miss Serena Dal Forno
Address 68123 0
Medlab Clinical. 66 McCauley Street, Alexandria, New South Wales 2015
Country 68123 0
Australia
Phone 68123 0
1300 369 570 Ext. 120
Fax 68123 0
Email 68123 0
serena_dalforno@medlab.co
Contact person for scientific queries
Name 68124 0
Prof Luis Vitetta
Address 68124 0
Medlab Clinical. 66 McCauley Street, Alexandria, New South Wales, 2015
Country 68124 0
Australia
Phone 68124 0
1300 369 570 Ext. 106
Fax 68124 0
Email 68124 0
luis_vitetta@medlab.co

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All IPD that underlie results in a publication
When will data be available (start and end dates)?
Upon study completion, no-end date.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Pharmacokinetic, safety and tolerability
How or where can data be obtained?
Unrestricted access via web address, TBA
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary