Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000295347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
9/02/2026
Date registered
Help: Date registered
9/03/2026
Date last updated
Help: Date last updated
2/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
9/03/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
A Clinical Study Comparing eRapa and Rapamune in Healthy Adult Volunteers.
Scientific title
A Phase 1, Open-label, Randomised, 2-part, 2-way Crossover Study to Evaluate the Comparative Bioavailability of eRapa versus Rapamune in Healthy Adult Participants.
Additional trial identifiers [1] 316423 0
MTX230-102
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
familial adenomatous polyposis 340527 0
Condition category
Condition code
Cancer 336729 336729 0 0
Other cancer types
Human Genetics and Inherited Disorders 336913 336913 0 0
Other human genetics and inherited disorders
Oral and Gastrointestinal 336914 336914 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Single oral dose of 0.5 mg eRapa capsules given under fasted conditions.
Intervention period: includes randomisation, pre-treatment procedures, administration of a single dose of eRapa and Rapamune, and various assessments according to the Schedule of Activities as per the protocol. Each participant will complete two treatment periods, one for each trial drug, separated by a washout interval. After the washout, pre-treatment procedures will be repeated starting from Day -1 in preparation for the second treatment period.
• 7 days: Period 1 Study Intervention
• 14-20 days: Washout interval between each intervention as required.
Patients will be required to fast for atleast 8 hours prior to each intertention and with no food consumed at least 2 hours post dose.
Total duration of intervention = approximately 82 days
PK blood samples will be collected pre dose and post dose to assess study concentrations in the blood.

Intervention code [1] 333084 0
Treatment: Drugs
Description of the comparator or control
Single oral dose of 0.5 mg Rapamune tablets given under fasted conditions
Control group
Active

Outcomes
Primary outcome [1] 344242 0
To assess the PK of a single dose of eRapa versus Rapamune administered under fasted conditions in healthy adult participants
Timepoint [1] 344242 0
Time windows for PK blood sample collection are: 1. pre-dose (up to 45 minutes before dosing); 2. 0.5h, 1h, 2h, 3h, 4h post dose ±5 minutes window; 3. 6h, 8h, 12h, 24h, 48h, 72h, 96h post dose, ±15 minutes; 4. 144 hours post-dose, ± 4 hours.
Secondary outcome [1] 457216 0
The safety and tolerability of  single doses of eRapa will be evaluated as a composite secondary endpoint in healthy adult participants.
Timepoint [1] 457216 0
• Vital signs (screening, Day1, Pre-dose, Day1-2h, Day1-4h, Day1-12h, Day2, Day3, Day4, Day5, Day7, 30days post dose) • Physical examinations (screening, Day1, 30days post dose) • ECG (screening, Day1, Pre-dose, Day1-2h, Day1-3h, Day1-4h, Day1-12h, Day2, Day5, Day7, 30days post dose). • adverse events (TEAEs) and withdrawals due to TEAEs to be assessed from screening to 30days post dose • Safety Laboratory bloods to be collected screening, Day1, Day3 and 30days post dose • Safety urinalysis to be collected screening, Day1, Day3 and 30days post dose

Eligibility
Key inclusion criteria
1. Male or female participants who are overtly healthy as determined by screening study assessments.
2. Participants must be between 18 and 65 years of age inclusive, at the time of signing the consent form.
3. A body mass index (BMI) within the range 18 and 32 kg/m2 inclusive.
4. Male and/or female assigned at birth, inclusive of all gender identities.

Male participants are eligible to participate if they agree to the following prior to the first dose of study intervention, during the study, and for 90 days plus 5 half-lives of eRapa after the last dose of study intervention:
• Refrain from donating sperm
• Be abstinent from intercourse where pregnancy can occur (abstinent on a long term and persistent basis) and agree to remain abstinent, OR
Must agree to use contraception/barrier as detailed below:
•. Agree to use an external condom with a partner of childbearing potential, agree to use of an additional highly effective contraceptive method when having sexual intercourse with a partner able to give birth who is not currently pregnant.
• Agree to use an external condom when engaging in any activity that allows for passage of ejaculate to another person

Female participants are eligible to participate if not pregnant or breastfeeding, and one of the following conditions applies:
• Is of non-childbearing potential
• Is of childbearing potential and using an established contraceptive method that is highly effective during the study intervention period and for at least 12 weeks after the last dose of study intervention, and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
• A participant of Childbearing potential in addition to an established contraceptive method must also have a negative highly sensitive pregnancy test (serum at screening, urine at baseline), within 24 hours before the first dose of study intervention, If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
5. Signed informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
1. Have a history of or a current immunosuppressive condition (e.g., human immunodeficiency virus infection).
2. Have any illness, judged by the Principal Investigator (PI) or delegate as clinically significant, in the 3 months prior to the first dose of study intervention.
3. Have PI determined current clinically significant infection or clinically significant infection within 6 months of first dose of study intervention (e.g., opportunistic infections or those requiring hospitalisation or parenteral antimicrobial therapy).
4. Have a history of chronic or recurrent infectious disease within the last 2 years.
5. Have symptomatic herpes zoster or herpes simplex within 12 weeks of first dose of study intervention, or more than 1 episode of local herpes zoster, or a history of disseminated zoster.
6. Have history of malignancy within the past 5 years, except for locally confined malignancies that have been definitively treated and are considered cured, with no evidence of recurrence, such as basal cell carcinoma of the skin.

Liver Safety
7. Blood result: Aspartate aminotransferase (AST)/ and alanine aminotransferase (ALT) greater or equal to 1.5 x upper limit of normal (ULN). Total bilirubin greater or equal to 1.5 x ULN.
Note: Participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is = ULN.

Prior/Concomitant Therapy
8. Participant is taking medications that are considered strong inducers or inhibitors of cytochrome P450 3A4/5 (CYP3A4/5) or strong inducers or inhibitors of P-glycoprotein 1 (P-gp1) that cannot be discontinued at least 1 week prior to first dose of study intervention and for the duration of the study.

9. Have received treatment with any drug known to have a potential for major organ toxicity in the last 3 months before the first dose of this study intervention.

10. Have received treatment with any medication (including over-the-counter and/or prescription medicines [including hormonal replacement therapy for postmenopausal participants], nutraceuticals, Cannabidiol (CBD), herbal supplements such as St. John's Wort (Hypericum perforatum) and recreational drugs), with the exception of hormonal contraception, within the last 2 weeks or 5 half-lives of that drug (whichever is longer) prior to the first dose of this study intervention through to trial completion
Note: Occasional paracetamol (maximum dose of 2 g/day) and ibuprofen 400mg/day) is permitted for use at any time during the study.

11. Have, or plan to receive, any live-attenuated vaccine within 4 weeks prior to Day 1 of trial, during intervention and up to 4 weeks following completion.

12. Have had, or plan to have, contact with any household or individuals who have received vaccination with live or attenuated live virus within 4 weeks prior to Day 1 of dosing, during intervention and up to 8 weeks following completion.

Prior/Concurrent Clinical Study Experience
13. Have known hypersensitivity to investigational medicinal product (IMP) ingredients (sirolimus, lactose monohydrate, sodium cholate, glycerol and talc) or history of a significant allergic reaction to IMP ingredients as determined by the Investigator, such as anaphylaxis requiring hospitalisation. Or any other significant allergy that the principal investigator or delegate consider clinically significant.

14. Current or previous participation in another investigational research study where the participant has received an investigational drug or drug/device within 30 days or 5 of its half-lives (whichever is longer) prior to the first dose of this study intervention or has received an investigational biologic within 12 weeks or 5 of its half-lives (whichever is longer) prior to the first dose of this study intervention.
Note: Participants who have participated in Part 1 of this study are not eligible for enrolment into Part 2 of this study.

Safety Laboratory Assessments
15. Positive screen for drugs of abuse (methamphetamine, amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, phencyclidine, tricyclic antidepressants) and alcohol at screening and on Day -1. Cotinine testing on Day -1 only.

16. Positive serology for hepatitis B virus surface antigen, hepatitis B virus core antibody, or hepatitis C virus, or history of hepatitis from any cause with the exception of hepatitis A.

17. Presence or sequelae of gastrointestinal, liver, or kidney (estimated creatinine clearance =90 mL/min, using the Cockcroft-Gault formula; if calculated creatinine clearance is =90 mL/min a 24-hour urine collection may be performed to assess renal function) disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs (e.g. small bowel obstruction, pancreatitis, previous major gastrointestinal surgery).

Other Exclusion Criteria
18. Clinically significant abnormalities detected on 12-lead ECG of either rhythm or conduction (e.g., corrected QT interval by Fridericia’s formula >450 msec for males or >470 msec for females; known to have long QT syndrome). Mean values per parameter will be considered. A first-degree heart block will not be considered as a significant abnormality.

19. Clinically significant abnormalities detected on vital signs. If an initial vital sign measurement is outside the range required by the protocol or shows a profound/unexpected change, the measurement may be repeated after the participant has rested for approximately 5 to 10 minutes to confirm the value or rule out temporary factors.

20. Significant blood loss (including blood donation [>500 mL]) within 30 days prior to screening, plasma donation within 2 weeks prior to screening or platelet donation 6 weeks prior to dosing and through to end of study.

21. Current use of nicotine-containing products, including but not limited to cigarettes, e-cigarettes/vaping devices, nicotine patches, nicotine gum, or other nicotine replacement therapies. Participants must have discontinued all nicotine-containing products for at least 72 hours prior to cotinine testing on Day -1.
Note: casual smoking/vaping, defined as the equivalent of <5 cigarettes per week, is permitted provided the participant agrees to abstain from smoking and the use of nicotine containing products for the entire duration of the intervention period.

22. Active drug or alcohol abuse (sustained use of more than 4 glasses of wine, beer or equivalent/day) within 2 years prior to the first dose of study intervention.

23. Investigator or other site staff or Biodexa employees directly involved in the conduct of the study, and their respective family members.

24. Any condition or circumstances that, in the opinion of the Principal Investigator or delegate, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-availability
Statistical methods / analysis
A full Statistical Analysis Plan (SAP) will be finalised prior to database lock and will include a more technical and detailed description of the statistical analyses described in this section. This section is a summary of the planned statistical analyses of the most important data pertaining to the primary and secondary objectives.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/03/2026
Actual
20/04/2026
Date of last participant enrolment
Anticipated
9/08/2026
Actual
Date of last data collection
Anticipated
14/12/2026
Actual
Sample size
Target
30
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 29090 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 45382 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 321029 0
Commercial sector/Industry
Name [1] 321029 0
Biodexa Australia Pty LTD
Country [1] 321029 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Biodexa Australia PTY Ltd
Address
Country
Australia
Secondary sponsor category [1] 323735 0
None
Name [1] 323735 0
Address [1] 323735 0
Country [1] 323735 0
Other collaborator category [1] 283857 0
Other Collaborative groups
Name [1] 283857 0
Southern Clinical Development Consulting
Address [1] 283857 0
Country [1] 283857 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319567 0
Bellberry Human Research Ethics Committee F
Ethics committee address [1] 319567 0
Ethics committee country [1] 319567 0
Australia
Date submitted for ethics approval [1] 319567 0
28/01/2026
Approval date [1] 319567 0
04/03/2026
Ethics approval number [1] 319567 0

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

Contacts
Principal investigator
Name 147730 0
Mr James Connell
Address 147730 0
CMAX Clinical Research, Ground floor, 21/24 North terrace, Adelaide, SA 5000
Country 147730 0
Australia
Phone 147730 0
+61 421 018 611
Fax 147730 0
Email 147730 0
[email protected]
Contact person for public queries
Name 147731 0
CMAX C19225 Study Team
Address 147731 0
CMAX Clinical Research, Ground floor, 21/24 North terrace, Adelaide, SA 5000
Country 147731 0
Australia
Phone 147731 0
+61 870887900
Fax 147731 0
Email 147731 0
[email protected]
Contact person for scientific queries
Name 147732 0
James Connell
Address 147732 0
CMAX Clinical Research, Ground floor, 21/24 North terrace, Adelaide, SA 5000
Country 147732 0
Australia
Phone 147732 0
+61 870887900
Fax 147732 0
Email 147732 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• This research study will share some of the participant's information with the below people/organisations:

Doctor/GP/other nominated health care provider: CMAX will tell the participant's regular health care provider that they are taking part in this research project. The health provider may add this information to the participant's medical records. If CMAX finds relevant information that supports participant's ongoing care, CMAX will share this information with the participant's healthcare provider so they can provide appropriate care.

Analysing samples and data: This research study will send participant's samples and data to Australian and international laboratories to be analysed. Participants should note that some data derived from your participation in this study will be sent overseas; the regulatory regimes governing data access and use in other countries may not be the same as those that are in place in Australia. By signing the Consent Form, the participant authorises release of, or access to, this confidential information to the relevant study personnel and regulatory authorities as noted above.

Regulatory authorities: Information obtained during the research study are subject to inspection for the purpose of verifying the study procedures and data by the relevant authorities (such as the TGA in Australia or the United States of America Food and Drug Administration), authorised representatives of the Sponsor such as study monitors acting on behalf of the Sponsor and its affiliates, representatives, partners, or collaborators, and vendors utilised by the Sponsor for study conduct, the Human Research Ethics Committee (HREC) that reviewed and approved this study, the Institution at which this study is being conducted, or as required by law.

Contract Research Organisation (CRO): Study monitors (people working for or on behalf of the trial Sponsor) to visit the clinical unit to review the clinical trial data so they can verify that study procedures have been followed and the study data have been entered correctly in the study records. This process is called ‘data verification’. This process typically takes place during regular monitoring visits to the CMAX facilities. If for some reason monitors cannot travel to or access the CMAX clinical unit in person to perform this task, participants trial records may be reviewed offsite through a secure electronic platform where your name and other identifiable information will be visible. Monitors are only allowed to view the information for data verification and are not allowed to share your data with other parties. Whether your medical files are reviewed at the clinical unit or remotely for the purposes of the study, your records will be kept secure during this process.

Other parties if legally required: By law, CMAX may be required to share participants information with others in certain circumstances. This research study involves the collection of information about your use of drugs. Participation in the research study includes urine analysis to determine the presence of drugs of abuse, such as tetrahydrocannabinol (THC) e.g. cannabis or marijuana, cocaine, amphetamines, barbiturates, benzodiazepines e.g. diazepam and opiates. The test may reveal that the participant have previously used illegal drugs. That information will be stored in a re-identifiable (or coded) format. In the event that CMAX Clinical Research is required by law to disclose that information, it may be used against the participant in legal proceedings or otherwise. Signing the Consent Form means that the participant agrees to have this testing; it will not be done without your consent.

Publishing study information

Sponsor/CMAX will share certain information from this study so that others can use it and understand the study findings. This study information does not identify the participant individually.

Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Analysis of the study data will be carried out as stated in the protocol under statistical analysis.

When can requests for individual participant data be made (start and end dates)?
From:
24/08/2026
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Request to be made to CMAX who hold the participant medical records.
CMAX C19225 Study Team (08) 7088 7900



Are there extra considerations when requesting access to individual participant data?
No


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.