Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000942459p
Ethics application status
Submitted, not yet approved
Date submitted
27/07/2025
Date registered
29/08/2025
Date last updated
29/08/2025
Date data sharing statement initially provided
29/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised open-label crossover study to investigate the safety, tolerability, pharmacokinetics, relative bioavailability, and pharmacodynamics of single doses of Katamine immediate release (KET-IR) and Ketamine abuse deterrent (KET-AD) oral ketamine capsules in healthy volunteers.
Scientific title
A randomised open-label crossover study to investigate the safety, tolerability, pharmacokinetics, relative bioavailability, and pharmacodynamics of single doses of Katamine immediate release (KET-IR) and Ketamine abuse deterrent (KET-AD) oral ketamine capsules in healthy volunteers.
Secondary ID [1] 314999 0
KETI-CAPS-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar disorder 338333 0
Condition category
Condition code
Mental Health 334625 334625 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This phase I study aims to recruit healthy volunteers to investigate the pharmacokinetics of two different presentations of ketamine.
1. KET-IR (160mg) is an immediate release formulation of ketamine
2. KET-AD (160mg) is an abuse deterrent formulation of ketamine.
Participants will be enrolled in 2 groups of 6 each (3 men and 3 woman). Each participant will attend 2 treatment sessions and receive two different oral formulations of Keticap®. In Period 1, Participants will be randomised to receive either a single dose of KET-IR (160 mg) or single dose of KET-AD (160 mg) in the first study session. Following at least 7 days wash-out period the participants will receive the alternate formulation to the one received in period 1second formulation in the final study session.
The study will be conducted in a phase I unit and will be supervised by trained qualified research staff to ensure adherence to the intervention.
Intervention code [1] 331590 0
Treatment: Drugs
Comparator / control treatment
The study is a comparison between the two different presentations of ketamine. The reference comparator' presentation, is the immediate release formulation of ketamine, KET-IR.
Control group
Active

Outcomes
Primary outcome [1] 342299 0
To investigate the PK of single oral doses of two different formulations, KET-IR and KET-AD in healthy adult men and women. Parameters to be evaluated are Maximum plasma concentration (Cmax), dose-normalised maximum plasma concentration (Cmax/Dose), time of maximum plasma concentration (tmax), time prior to the first measurable (non-zero) concentration (tlag), area under the plasma concentration-time curve (AUC) from time zero to time t (AUC0–t), dose-normalised AUC from time zero to time t (AUC0–t/Dose), AUC from time zero extrapolated to infinite time (AUCinf)
Timepoint [1] 342299 0
Blood samples for assay of Ketamine and its metabolites will be taken before and at 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 h after dosing on Day 1.
Primary outcome [2] 342405 0
To investigate the relative bioavailability’ of single oral doses of two different formulations, KET-IR and KET-AD in healthy adult men and women.
Timepoint [2] 342405 0
Blood samples for assay of Ketamine and its metabolites will be taken before and at 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 h after dosing on Day 1.
Secondary outcome [1] 450277 0
To investigate the safety of single oral doses of two different formulations, KET-IR and KET-AD in healthy adult men and women
Timepoint [1] 450277 0
Assessments will be performed prior to investigational product administration and on days 1 and 2 following administration of investigational product.. Blood safety will also be performed at Day 14.
Secondary outcome [2] 450699 0
To investigate the tolerability of single oral doses of two different formulations, KET-IR and KET-AD in healthy adult men and women
Timepoint [2] 450699 0
Assessments will be performed prior to investigational product administration and on days 1 and 2 following administration of investigational product.. Blood safety will be performed at before the first dose, and 1, 4, 6 and 24 hours after each dose in this study.

Eligibility
Key inclusion criteria
1. Male and female healthy volunteers.
2. Aged 18–55 years.
3. Non-smokers
4. A body mass index (BMI); Quetelet index) in the range 18.0–30 kg/m2.
5. Able to understand the nature of the trial and any hazards of participating in it.
6. Willingness to give written consent to participate after reading the information and consent form
7. Agree to follow the contraception requirements of the trial.
8. Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication.
9. Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Clinically significant (in the opinion of the PI or delegate) medical history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
2. Presence of an anxiety disorder, bipolar disorder or depression (moderate to severe) and psychosis as determined using a structured clinical Mini-International Neuropsychiatric Interview (MINI).
3. First degree relative with psychosis (through self-report).
4. Presence of clinically significant acute or chronic illness or history of chronic illness, as determined by the PI or delegate.
5. History of clinically significant (in the opinion of the PI or delegate) endocrine, thyroid, hepatic, respiratory or renal disease.
6. Diabetes mellitus, coronary heart disease, or history of any neurological condition (including migraines) or mental illness (prior DSM-5 diagnosis of a psychotic disorder or Major Depressive Disorder (MDD) with psychotic features, bipolar or related disorders, intellectual disability, autism spectrum disorder, borderline personality disorder). Resolved anxiety and depression may be permitted at the discretion of the PI/delegate.
7. Surgery (e.g. stomach bypass) or medical condition that might affect absorption of medicines. Cholecystectomy is exclusionary if the PI/delegate deems the participant to be of high-risk of malabsorption. Gilbert’s syndrome is permitted at the discretion of the PI/delegate.
8. Presence or history of severe adverse reaction to any drug or a known hypersensitivity to Ketamine, or any component of the KET-IR and KET-AD formulations (lactose, Kelcogel, PEG 1500, Gelucire, gelatin, HPMC).
9. Use of a prescription medicine during the 30 days before the first dose of trial medication, or use of an over-the-counter medicine (excluding herbal supplements and vitamins), with the exception of acetaminophen (paracetamol) and hormonal contraceptive medications, during the 7 days before the first dose of trial medication.
10. Receipt of an investigational product (including prescription medicines) as part of another clinical trial within the 3 months before first admission to this study; in the follow-up period of another clinical trial at the time of screening for this study.
11. Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly (for men) or more than 14 units of alcohol weekly (for women), where 1.1 unit equals 285 mL of full-strength beer; 0.9 unit equals 425mL low-strength beer; 1 unit equals 100 mL of wine or 30 mL of spirits.
12. Positive cotinine test at check-in. Positive urine drug screen or alcohol breath test at Screening or check-in.
13. Has a history of suicide attempt(s) or suicidal ideation as indicated by the C-SSRS.
14. Mean blood pressure and mean heart rate in supine position outside the ranges: blood pressure 90–140 mm Hg systolic, 40–90 mm Hg diastolic; heart rate 40–100 beats/min. Mean pulse oximetry SpO2 less than or equal to 90%. Repeats permitted at PI/delegate discretion.
15. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP) greater than or equal to 1.5 x upper limit of normal (ULN) at screening. A repeat is allowed on one occasion for determination of eligibility.
16. Possibility that the volunteer will not cooperate with the requirements of the protocol.
17. Positive test for hepatitis B, hepatitis C or HIV, or pregnancy.
18. Loss of more than 400 mL blood during the 3 months before the Screening visit, e.g. as a blood donor.
19. Vegetarians or vegans who are not willing to take a medicine that includes gelatine of animal origin.
20. No food or drink containing grapefruit will be allowed from 7 days before dosing until the end of the trial
21. No alcoholic drinks or smoking will be allowed during the period from midnight the day before admission until the end of each period of residence
22. No strenuous exercise will be allowed from 3 days before admission until the end of each period of residence, and for 3 days before each outpatient visit
23. Participants must not sunbathe or use a sunbed during the study
24. Unwilling to abide by the study restrictions .
25. Any other reason, in the opinion of PI or delegate, deeming the volunteer unsuitable for trial participation.

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 will not be concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 319551 0
Commercial sector/Industry
Name [1] 319551 0
Neurocentrx Pharma Pty Ltd
Country [1] 319551 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Neurocentrx Pharma Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 322055 0
None
Name [1] 322055 0
Address [1] 322055 0
Country [1] 322055 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318125 0
Bellberry Human Research Ethics Committee C
Ethics committee address [1] 318125 0
Ethics committee country [1] 318125 0
Australia
Date submitted for ethics approval [1] 318125 0
29/07/2025
Approval date [1] 318125 0
Ethics approval number [1] 318125 0

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

Contacts
Principal investigator
Name 143198 0
Dr Angela Rowland
Address 143198 0
CMAX Pty Ltd Ground Floor, 21-24 North Terrace, Adelaide SA 5000
Country 143198 0
Australia
Phone 143198 0
+61 0439682089
Fax 143198 0
Email 143198 0
[email protected]
Contact person for public queries
Name 143199 0
Angela Rowland
Address 143199 0
CAMX Pty Ltd Ground Floor, 21-24 North Terrace, Adelaide SA 5000
Country 143199 0
Australia
Phone 143199 0
+61 0439682089
Fax 143199 0
Email 143199 0
[email protected]
Contact person for scientific queries
Name 143200 0
Angela Rowland
Address 143200 0
CAMX Pty Ltd Ground Floor, 21-24 North Terrace, Adelaide SA 5000
Country 143200 0
Australia
Phone 143200 0
+61 0439682089
Fax 143200 0
Email 143200 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This study serves to assess the pharmacokinetics of the two different formulation of ketamine HCl, the information generated will not be of any value to the individual participants.



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.