PharmacokineticsPhase 1NCT06854783
Safety and Pharmacokinetics of Cannabidiol in Healthy Volunteers
A Phase 1 study testing Cannabidiol in people with Pharmacokinetics, run by Tiamat Australia Pty Ltd at 1 site in Australia.
Trial summary
The purpose of this study is to assess the pharmacokinetics, safety, tolerability and food effect of investigational drug MRX1 in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Jul 2025to 1 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Multiple Dose Study to Assess the Pharmacokinetics, Safety, Tolerability, and Food Effect of MRX1 in Healthy Adults
The purpose of this study is to assess the pharmacokinetics, safety, tolerability and food effect of investigational drug MRX1 in healthy adults.
Read the detailed description
MRX1 is an oral solution containing cannabidiol.
The primary objective of this study is the assess the pharmacokinetic profile of MRX1 at two doses when administered twice daily in healthy adults. The secondary objectives are to assess the safety and tolerability of MRX1 and to characterise the effect of a high fat, high calorie meal on the pharmacokinetics of a single dose of MRX1.
A total of 20 healthy volunteers (10 male and 10 female) will be sequentially enrolled into 2 treatment groups, with 5 males and 5 females in each group.
The duration of the study is up to 52 days per participant for Group A and 37 days per participant for Group B, including screening and follow up.
- Conditions
- Pharmacokinetics
- Being tested
- Cannabidiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Cannabidiol
| Study group | Role | What they receive |
|---|---|---|
| Group A Low Dose | Experimental | Group A:
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). Receives: Drug: Cannabidiol |
| Group B High Dose | Experimental | 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. Receives: Drug: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration [Cmax]
Maximum observed concentration for CBD, 7-OH-CBD and 7-COOH-CBD.
Measured: Days 1, 6 and 21
Pre-dose concentration [Ctrough]
Pre-dose concentration inclusive of CBD, 7-OH-CBD and 7-COOH-CBD.
Measured: From Day 2 to Day 6.
Time to maximum observed concentration [Tmax]
Time to maximum observed concentration of CBD, 7-OH-CBD and 7-COOH-CBD.
Measured: Days 1 and 6.
Area under the plasma concentration time curve 0-12 hours [AUC0-12]
The area under the plasma concentration-time curve, from time 0 (time of dosing) to 12 hours for CBD, 7-OH-CBD and 7-COOH-CBD.
Measured: Days 1, 6 and 21
Area under the plasma concentration-time curve 0-24 [AUC0-24]
The area under the plasma concentration-time curve, from time 0 (time of dosing) to 24 hours for Group B and Group A, Period 1 for CBD, 7-OH-CBD and 7-COOH-CBD.
Measured: Day 1
Secondary outcomes (1)
Frequency and severity of adverse events
The frequency and severity of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI) as assessed by CTCAE v5.0.
Measured: From Day 1 to end of study at Day 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start14 Jul 2025
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiamat Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ananda Pharma plc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854783
- Sponsor's protocol ID
- MRX1-1-001
- Status last verified
- Jul 2025
- First submitted
- 14 Feb 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multiple Dose Study to Assess the Pharmacokinetics, Safety, Tolerability, and Food Effect of MRX1 in Healthy Adults
- ClinicalTrials.gov ID
- NCT06854783
- Acronym / sponsor ID
- MRX1-1-001
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tiamat Australia Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Ananda Pharma plc
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the pharmacokinetics, safety, tolerability and food effect of investigational drug MRX1 in healthy adults.
Detailed description
MRX1 is an oral solution containing cannabidiol.
The primary objective of this study is the assess the pharmacokinetic profile of MRX1 at two doses when administered twice daily in healthy adults. The secondary objectives are to assess the safety and tolerability of MRX1 and to characterise the effect of a high fat, high calorie meal on the pharmacokinetics of a single dose of MRX1.
A total of 20 healthy volunteers (10 male and 10 female) will be sequentially enrolled into 2 treatment groups, with 5 males and 5 females in each group.
The duration of the study is up to 52 days per participant for Group A and 37 days per participant for Group B, including screening and follow up.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Low Dose | Experimental | Drug: CannabidiolGroup A: 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). |
| Group B High Dose | Experimental | Drug: CannabidiolGroup 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolCannabidiol | Drug | Group A Low Dose, Group B High Dose |
Primary outcome
Maximum observed concentration [Cmax]
Time frame: Days 1, 6 and 21
Maximum observed concentration for CBD, 7-OH-CBD and 7-COOH-CBD.
Pre-dose concentration [Ctrough]
Time frame: From Day 2 to Day 6.
Pre-dose concentration inclusive of CBD, 7-OH-CBD and 7-COOH-CBD.
Time to maximum observed concentration [Tmax]
Time frame: Days 1 and 6.
Time to maximum observed concentration of CBD, 7-OH-CBD and 7-COOH-CBD.
Area under the plasma concentration time curve 0-12 hours [AUC0-12]
Time frame: Days 1, 6 and 21
The area under the plasma concentration-time curve, from time 0 (time of dosing) to 12 hours for CBD, 7-OH-CBD and 7-COOH-CBD.
Area under the plasma concentration-time curve 0-24 [AUC0-24]
Time frame: Day 1
The area under the plasma concentration-time curve, from time 0 (time of dosing) to 24 hours for Group B and Group A, Period 1 for CBD, 7-OH-CBD and 7-COOH-CBD.
1 secondary outcome
Frequency and severity of adverse events
Time frame: From Day 1 to end of study at Day 24.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabidiol in people with Pharmacokinetics, run by Tiamat Australia Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration [Cmax] (time frame: Days 1, 6 and 21). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.