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Trial registered on ANZCTR


Registration number
ACTRN12619001494123p
Ethics application status
Submitted, not yet approved
Date submitted
16/10/2019
Date registered
29/10/2019
Date last updated
12/02/2020
Date data sharing statement initially provided
29/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The comparison of a NanoCelle™ cannabis formulation (NanaBis™) and a cannabis oil formulation derived from the same raw cannabis oil material administered in equal concentration to the oral mucosa in healthy volunteers: a pharmacokinetic, open-label, randomised exploratory study.
Scientific title
The comparison of a NanoCelle™ cannabis formulation (NanaBis™) and a cannabis oil formulation derived from the same raw cannabis oil material administered in equal concentration to the oral mucosa in healthy volunteers: a pharmacokinetic, open-label, randomised exploratory study.
Secondary ID [1] 299568 0
Nill known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 314841 0
Condition category
Condition code
Alternative and Complementary Medicine 313179 313179 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sampling Method: Randomisation
Allocation: NanaBis™ (cannabis spray) group or cannabis oil group
Intervention Model: Comparison study
Masking: Open label
This is an open label, randomised comparison study. This study will be performed in healthy subjects to determine the absorption and bioavailability properties of a micellised (NanoCelle™) THC:CBD formulation in the form of an oro-buccal spray (NanaBis™) (treatment 1) when compared to an equal concentration cannabis oil formulation derived from the same raw cannabis oil material (treatment 2). NanaBis™ contains 7.5 mg THC and 7.5 mg CBD in 0.9 mL in 6 sprays. The cannabis oil formulation contains 7.5 mg THC and 7.5 mg CBD in 0.9 mL.

Subjects will be screened from 28 days up to 2 days prior to study day 1 (dosing day). Enrolled participants will be admitted into the study facility on the evening of study day 0 and will be advised to fast from midnight. Randomisation to treatment 1 or treatment 2 will occur at this time. On study day 1 (morning), a pre-dose blood sample will be collected from the participants while fasting. Subsequently, 6 sprays of NanaBis™ (treatment 1) will be administered to the buccal mucosa of 5 volunteers and 0.9 mL drops of a cannabis oil formulation (treatment 2) will be administered sublingually to the remaining 5 volunteers at 0 minutes. Additional blood samples will be collected at the following time points: 30, 60, 90, 120, 180, 240, 360 minutes, 12 hours and at 24 hours. On study Day 2, after the 24 hours blood sample has been collected, participants will be discharged from the study facility.

Participants will be closely monitored for adverse events while participating in the study. All blood samples will be processed at the study facility and plasma aliquots will be extracted from the whole blood samples and frozen at -80 degrees celsius. Plasma samples will be shipped to the analysing Laboratory in Thebarton SA (Agilex Biolabs).
Intervention code [1] 315824 0
Treatment: Drugs
Comparator / control treatment
Cannabis oil formulation
Control group
Active

Outcomes
Primary outcome [1] 321696 0
Composite primary outcome: Pharmacokinetic properties of the two formulations as measured by plasma assay of THC, CBD and THC/CBD metabolites pharmacokinetics (AUC and T1/2)
Timepoint [1] 321696 0
Blood sample collection for plasma analysis of THC, CBD and metabolites on study day 1 &2 at the following time points:
Baseline:30, 60, 90, 120, 180, 240, 360 minutes, 12 hours and at 24 hours post administration of treatment 1 or 2 (NanaBis or Cannabis oil formulation).
Secondary outcome [1] 376318 0
No secondary outcome
Timepoint [1] 376318 0
No secondary outcome

Eligibility
Key inclusion criteria
1) Participants greater than or equal to 18 years of age at time of entry on the study;
2) Participants have the cognitive ability to understand the informed consent process and to give and sign informed consent to the experimental treatment;
3) Participants agree to undergo the insertion of an intravenous cannula on study day 1 for approximately 24 hours with multiple blood draws;
4) Participants agree to adhere to the study protocol;
5) Participants agree to abstain from using any other products containing cannabinoids for the duration of their participation in the study (from the signing of the informed consent to study completion on study day 7);
6) Participants are willing to take the study medication, which may exhibit psychoactive effects;
7) Participants consent to having urine tests for pregnancy if applicable;
8) Participants consent to having urine tests for recent illicit substance use including THC;
9) Participants have no history of any chronic diseases;
10) 10) Participants agree to not drive and/or operate heavy machinery from study day 0 to study day 7 (6 days after administration of the IP on study day 1).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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) Subjects who test positive to illicit substance use including THC during the screening visit assessments and on study day 0;
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 (15 days wash-out period required);
9) The current use of any over-the-counter or prescription medications (15 days wash-out period required).

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
Other design features
Phase
Phase 0
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 304052 0
Commercial sector/Industry
Name [1] 304052 0
Medlab Clinical
Country [1] 304052 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical
Address
66 Mc Cauley st, Alexandria, Nsw, 2015.
Country
Australia
Secondary sponsor category [1] 304246 0
None
Name [1] 304246 0
Address [1] 304246 0
Country [1] 304246 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304544 0
National Institute of Integrative Medicine (EC0046)
Ethics committee address [1] 304544 0
Ethics committee country [1] 304544 0
Australia
Date submitted for ethics approval [1] 304544 0
11/10/2019
Approval date [1] 304544 0
Ethics approval number [1] 304544 0

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

Contacts
Principal investigator
Name 97330 0
Dr James Kuo
Address 97330 0
Scientia Clinical Research, 5 Bright Building Corner High, Avoca St, Randwick NSW 2031
Country 97330 0
Australia
Phone 97330 0
+6102 9382 5800
Fax 97330 0
Email 97330 0
james.kuo@scientiaclinicalreserch.com.au
Contact person for public queries
Name 97331 0
Kavya Potlapelly
Address 97331 0
Medlab Clinical Ltd, 66 Mc Cauley st, Alexandria, NSW, 2015.
Country 97331 0
Australia
Phone 97331 0
+61 0281880311
Fax 97331 0
Email 97331 0
kava_potlapelly@medlab.co
Contact person for scientific queries
Name 97332 0
Luis Vitetta
Address 97332 0
Medlab Clinical Ltd, Mc Cauley st, Alexandria, NSW, 2015.
Country 97332 0
Australia
Phone 97332 0
+61 280941939
Fax 97332 0
Email 97332 0
luis_vitetta@medlab.co

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


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.