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Trial registered on ANZCTR


Registration number
ACTRN12618000391279
Ethics application status
Approved
Date submitted
2/03/2018
Date registered
16/03/2018
Date last updated
23/04/2019
Date data sharing statement initially provided
23/04/2019
Date results information initially provided
23/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Four-way crossover study to determine the safety, tolerability, and pharmacokinetics of ECs315 administered as a single or multiple sublingual wafer and oil to healthy volunteers
Scientific title
A phase I, open label, randomised, placebo controlled, four-way crossover study to determine the safety, tolerability, and pharmacokinetics of ECs315 administered as a single or multiple sublingual wafer and oil to healthy volunteers
Secondary ID [1] 294214 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy Induced nausea and vomiting 306864 0
Condition category
Condition code
Oral and Gastrointestinal 305969 305969 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A dose of ECs315 WaferiX equivalent to 10 mg CBD sublingually
A dose of ECs315 WaferiX equivalent to 20 mg CBD sublingually
A dose of ECs315 (5%) Oil equivalent to 10 mg CBD sublingually
Sativex® 4 actuations (equivalent to 10 mg CBD, 10.8 mg THC) as oromucosal spray
Cohort 1: receives a single dose of ECs315 WaferiX equivalent to 5 mg CBD sublingually (n=6).
Cohort 2: receives a single dose of each of 10 and 20 mg of WaferiX, 10 mg of Oil and Sativex in a randomised crossover design, with each dose separated by 3 days (n=12).
Cohort 3: A daily dose of ECs315 WaferiX equivalent to 20 mg CBD will be administered sublingually for 5 days (multiple dose) to a cohort of 6 patients. The dose will be administered as 10 mg Waferix twice a day.
The investigational products will be administered by site staff. Subjects are required to stay in the centre for the duration of the study.




Intervention code [1] 300506 0
Treatment: Drugs
Comparator / control treatment
Cohort 2: the compatator is Sativex® 4 actuations (equivalent to 10 mg CBD, 10.8 mg THC) administered as an oromucosal spray

for Cohort 1 and 3 subjects will be randomised to receive either placebo or active. Placebo wafers administered sublingually.
Control group
Placebo

Outcomes
Primary outcome [1] 305003 0
To assess the safety and tolerability of single and multiple sublingual dose of ECs315 in healthy volunteers.

Safety and tolerability will be evaluated from spontaneously reported or observed adverse events, scheduled physical examinations, vital signs, 12-lead ECGs, and clinical laboratory results
Timepoint [1] 305003 0
Safety will be evaluated from spontaneously reported or observed adverse events, scheduled (daily) physical examinations, vital signs, 12-lead ECGs, and clinical laboratory results, 7 days after the single dose administration and 14 days after multiple dose administration.
Secondary outcome [1] 343848 0
To determine and compare the pharmacokinetics (PK) of ECs315 sublingual wafer and oral oil with buccal Sativex® in healthy subjects after various doses given as single and multiple sublingual wafer and single sublingal dose of ECs315 oil.

At predetermined times, blood and urine samples will be obtained for the determination of the CBD PK after sublingual administration of ECs315. Descriptive statistics will be employed to compare the PK parameters of CBD after administration of ECs315 in wafer and oil formulation and Sativex.

Cmax, AUC, tmax, hlaf life and clearance of CBD will be calculated for each subject.
Timepoint [1] 343848 0
For single dose study (cohort 1 and 2): Blood samples will be collected pre-dose, and then 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose for single dose study.

For multiple dose study (cohort 3): Blood samples will be collected pre-dose, on day 1, 2, 3, 4 and 5, then 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 168 hours post last dose.

Eligibility
Key inclusion criteria
- Medically healthy, determined by non-clinically significant laboratory profiles, medical history, vital signs, physical examination, 12-lead ECG at screening as deemed by the Principal Investigator and/or Sponsor Medical Monitor.
- No history of cardiac disease.
- Resting heart rate, as measured by ECG in the range of 40 and 100 bpm inclusive.
- No active or chronic diseases/disorders, no history of hospitalization for illness within the six months prior to enrolment into study, and no major surgery within the 6 months prior to enrolment into study.
- Must have a body mass index in the range of 18 to 32 kg/m2 inclusive and body weight greater or equal 50 kg.
- Females must be non-pregnant, non-lactating, or postmenopausal for at least 1 year (as confirmed by follicle-stimulating hormone [FSH]), or surgically sterile for at least 6 months prior to dosing.
- Must be non-smokers for at least six months and/or not on nicotine containing products including Tobacco use (chewing or sniffing) or smoking cessation products prior to enrolment. This includes any form of inhaled tobacco including e-cigarettes. Social smokers who are otherwise healthy may be enrolled if they have not used nicotine-containing products within 2 weeks of dosing and agree to abstain for the duration of the study.
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of any clinically important cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator and/or Sponsor Medical Monitor.
- Acute disease state (e.g., nausea, vomiting, diarrhoea) within 7 days of Study Day 1.
- Used cannabinoids or a cannabinoid-based medicine within 12 months prior to receiving study medication and willingness to abstain from recreational drug use during the study period.
- Admitted alcohol abuse or consumption average of more than 2 standard units per day (a standard unit equals 350 ml of beer, 50 ml of 80-proof alcohol, or one 175 ml glass of wine) or history of alcoholism within the past 2 years.
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- Positive urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, phencyclidine, ecstasy, methamphetamines, methadone and opiates) at screening or Day -1 or a history of drug abuse within the past 2 years.
- History of any clinically important severe allergic or anaphylactic drug reaction or known or suspected hypersensitivity to compounds similar to the investigational product.
- Family history of long QT-syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death such as coronary artery disease, congestive heart failure or terminal cancer.
- History of suicide attempt or suicidal behaviour. Any recent suicidal ideation within the last 12 months (a level of 4 or 5 for any 1 item on the scale), or who are at significant risk to commit suicide, as judged by the Investigator using the C-SSRS at screening and on admission to the clinical unit on Day -1.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety
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)
VIC

Funding & Sponsors
Funding source category [1] 298850 0
Commercial sector/Industry
Name [1] 298850 0
BOD Australia
Address [1] 298850 0
Level 1, 377 New South Head Road
DOUBLE BAY NSW 2028
Country [1] 298850 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BOD Australia
Address
Level 1, 377 New South Head Road
DOUBLE BAY NSW 2028
Country
Australia
Secondary sponsor category [1] 298049 0
None
Name [1] 298049 0
None
Address [1] 298049 0
Country [1] 298049 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299794 0
Bellberry Ethics Committee
Ethics committee address [1] 299794 0
129 Glen Osmond Rd
Eastwood SA 5063
Ethics committee country [1] 299794 0
Australia
Date submitted for ethics approval [1] 299794 0
07/03/2018
Approval date [1] 299794 0
14/06/2018
Ethics approval number [1] 299794 0

Summary
Brief summary
To determine the pharmacokinetics and safety of ECs315 wafer in healthy volunteers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81590 0
Dr Jason Lickliter
Address 81590 0
Nucleus Network Limited,
Level 5, Burnet Tower, AMREP Precinct,
89 Commercial Road, Melbourne Victoria 3004 Australia
Country 81590 0
Australia
Phone 81590 0
+61 3 9076 8960
Fax 81590 0
Email 81590 0
jason.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 81591 0
Dr Adele Hosseini
Address 81591 0
BOD Australia Pty Ltd
Level 1, 377 New South Head Rd
Double Bay, NSW 2028
Country 81591 0
Australia
Phone 81591 0
+61 2 9199 5018
Fax 81591 0
Email 81591 0
adele.hosseini@bodaustralia.com
Contact person for scientific queries
Name 81592 0
Dr Adele Hosseini
Address 81592 0
BOD Australia Pty Ltd
Level 1, 377 New South Head Rd
Double Bay, NSW 2028
Country 81592 0
Australia
Phone 81592 0
+61 2 9199 5018
Fax 81592 0
Email 81592 0
adele.hosseini@bodaustralia.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not decided
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?
No
Results – basic reporting
Results – plain English summary