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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06854783




Registration number
NCT06854783
Ethics application status
Date submitted
14/02/2025
Date registered
3/03/2025

Titles & IDs
Public title
Safety and Pharmacokinetics of Cannabidiol in Healthy Volunteers
Scientific title
A Phase 1, Open-Label, Multiple Dose Study to Assess the Pharmacokinetics, Safety, Tolerability, and Food Effect of MRX1 in Healthy Adults
Secondary ID [1] 0 0
MRX1-1-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetics 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cannabidiol 100 MG/ML

Experimental: Group A Low Dose - Group A (2-period cross-over design to assess food effect):

Period 1 (Fasted): Cannabidiol at 2.5 mg/kg of body weight, administered twice daily (BID) for 5 days, with a single dose administered on the morning of Day 6 (n=10). All doses will be administered in a fasted state.

Following a 14-day washout period, all participants will enter Period 2.

Period 2 (Fed): Cannabidiol at 2.5 mg/kg of body weight, administered once on the morning of Day 21 following consumption of a standardised high fat, high calorie meal (n=10).

Experimental: Group B High Dose - Group B

Period 1 (Fasted): Cannabidiol at 7.5 mg/kg of body weight, administered BID for 5 days, with a single dose administered on the morning of Day 6 (n=10). All doses will be administered in a fasted state.


Treatment: Drugs: Cannabidiol 100 MG/ML
Cannabidiol 100mg/ml oral solution
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum observed concentration [Cmax]
Timepoint [1] 0 0
From Day 1 to end of study at Day 21.
Primary outcome [2] 0 0
Pre-dose concentration [Ctrough]
Timepoint [2] 0 0
From Day 2 to Day 6.
Primary outcome [3] 0 0
Time to maximum observed concentration [Tmax]
Timepoint [3] 0 0
Days 1 and 6.
Primary outcome [4] 0 0
Area under the plasma concentration time curve 0-12 hours [AUC0-12]
Timepoint [4] 0 0
From Day 1 to Day 21.
Primary outcome [5] 0 0
Area under the plasma concentration-time curve 0-24 [AUC0-24]
Timepoint [5] 0 0
Day 1
Secondary outcome [1] 0 0
Frequency and severity of adverse events
Timepoint [1] 0 0
From Day 1 to end of study at Day 24.

Eligibility
Key inclusion criteria
* Ability to provide voluntary, written informed consent.
* Males and females, aged 18 to 55 years inclusive at time of informed consent.
* Total body weight =50 kg and body mass index (BMI) between 18 and 32 kg/m2 inclusive.
* Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day -1.

Note: Definition of child-bearing potential is fertile and following menarche until becoming post-menopausal, unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause and follicle-stimulating hormone (FSH) documented in the post-menopausal range (=40 IU/L).

* WOCBP must agree to the use a highly effective birth control (refer to Appendix 11.1) from Screening through 30 days following the last dose of study drug.
* Male participants must agree to use highly effective birth control including condom (refer to Appendix 11.1) from Screening through 90 days following the last dose of study drug. Male participants with female partners that are surgically sterile or post menopausal (defined as being amenorrhoeic for at least 12 months without an alternative medical cause), or male participants who have undergone sterilisation and have had testing to confirm the success of the sterilisation, may also be included and will not be required to use above-described methods of contraception. Male participants must also agree not to donate sperm up to 90 days following the last dose of study drug.
* Considered healthy, as determined by medical evaluation by the Investigator including medical history and physical examination.
* Vital signs after 5 minutes resting in supine position within the following ranges: Systolic blood pressure: 90 to 140 mmHg inclusive; Diastolic blood pressure: 40 to 90 mmHg inclusive; Heart rate: 40 to 100 bpm inclusive.
* Standard 12-lead ECG with parameters (average of triplicate readings) after 10 minutes in supine position within the following ranges: QRS <120 msec; QT <500 msec; QTc =450 msec (both genders); PR interval =120 to =220 msec.
* Negative tests for HBsAg, HBcAb (if HBsAg positive), anti-HCV, and HIV antibody at Screening (positive anti-HCV antibody allowed if HCV PCR is negative).
* Screening and Day -1 safety laboratory test values within normal ranges. Out of normal range values may be accepted by the Investigator if not considered clinically significant, with the exception of the following: ALT or AST >1.5 x upper limit of normal (ULN); Total, indirect, or direct bilirubin >1.5 x ULN. Participants with Gilbert's syndrome with indirect bilirubin outside of the normal range will be excluded from the study.
* Willing to refrain from consumption of alcohol as follows: Group A: for at least 48 hours prior to Screening, Day -1, and Day 20, and throughout the in-patient confinement periods and post-dose follow-up visits (consumption of alcohol is permitted during the outpatient washout period); Group B: for at least 48 hours prior to Screening and Day -1, and throughout the study.
* Willing to defer blood donations to a blood service for minimum of 30 days following the last dose of study drug.
* In the opinion of the Investigator, is willing and able to comply with and understand study requirements and be available for the required study visits.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Female participant who is pregnant or breastfeeding, or planning to become pregnant or breastfeed, or planning to donate ova during study participation.
* History or presence of a medical condition that, in the opinion of the Investigator, would interfere with the evaluation of the study drug or lead to increased risk of harm.
* Presence of any chronic medical condition requiring ongoing treatment.
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to Screening, as per Investigator judgement.
* Documented evidence of current or past cardiovascular disease including cardiac arrhythmias or family history of congenital long QT syndrome, Brugada syndrome, or unexplained sudden cardiac death.
* Any gastrointestinal surgery or condition or disease that could affect drug absorption, distribution, or excretion (e.g., gastrectomy, cholecystectomy, diarrhea, recurrent nausea/vomiting).
* History of malignancy of any organ system (other than localised basal cell carcinoma of the skin or in situ cervical cancer considered treated and cured), treated or untreated, within 5 years before Screening, regardless of if there is no evidence of local recurrence or metastases.
* History of schizophrenia, bipolar disorder psychoses, disorders requiring lithium, attempted or planned suicide, or any other severe (disabling) chronic psychiatric diagnosis including generalised anxiety and obsessive-compulsive disorders. Hospitalisation within 5 years before Screening due to psychiatric illness or due to danger to self or others.
* Current use (or within the 3 months prior to Screening) of other cannabinoid or cannabis products.
* History of allergy or other adverse reaction to cannabinoid or cannabis products at any time in the past or known or suspected hypersensitivity to any of the components of the formulation.
* Current or recent (within 2 months prior to Screening) use of any tobacco or nicotine products (including e-cigarettes, vaping, or dipping) at >5 cigarettes per week or equivalent. Causal/social smokers (=5 cigarettes per week or equivalent) are permitted.
* History of substance abuse disorder(s), as determined by the Investigator, within 5 years of Screening, including but not limited to alcohol, illicit drugs, and inappropriate use of prescription drugs.
* Positive urine drug test or alcohol breath test at Screening or Day 1, unless there is an explanation deemed acceptable by the Investigator and/or the participant tests negative upon re-test (one re-test permitted per scheduled time point).
* Use of any prescription medicines or marijuana within 14 days of Day -1 or use of any nonprescription medicines, supplements, or vaccines within 7 days of Day 1. Occasional (PRN) paracetamol (up to 2 g/day) or ibuprofen (up to 1.2 g/day) use may be permitted, at Investigator discretion. Hormonal contraceptives are permitted.
* Consumption of food and/or beverages containing Seville oranges or Seville orange juice, or grapefruit or grapefruit juice, or poppy seeds within 7 days prior to Day -1.
* Consumption of caffeine/xanthine products within 24 hours prior to Day -1.
* Use of any investigational drug within 30 days or <5 half-lives, whichever is longer, prior to first dose of study drug.
* Donation or receipt of any blood or blood products at a blood bank or donation centre within 30 days prior to Screening.
* Identified as a site employee of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members (i.e., immediate, husband, wife or de facto and their children, adopted or natural) of the site employees or the Investigator.

Study design
Purpose of the study
Other
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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tiamat Australia Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Ananda Pharma plc
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06854783