Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000641493
Ethics application status
Approved
Date submitted
27/05/2025
Date registered
17/06/2025
Date last updated
17/06/2025
Date data sharing statement initially provided
17/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Trial to Examine the Amount of JNT-517 Entering the Bloodstream and the Effect of Food on Different Formulations of JNT-517
Scientific title
A Phase 1, Single Dose, Open-Label Trial to Evaluate the Relative Bioavailability and Food Effect of 2 Formulations of JNT-517 in Healthy Participants
Secondary ID [1] 314447 0
359-201-00004 (JNT517-104)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Phenylketonuria 337483 0
Condition category
Condition code
Metabolic and Endocrine 333849 333849 0 0
Metabolic disorders
Human Genetics and Inherited Disorders 333850 333850 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a Phase 1, open-label, 4-period, period-balanced trial in healthy participants. The trial will investigate the relative bioavailability of 2 formulations (Instant Release (IR) tablet and minitablet) of JNT-517 along with the effect of food on the pharmacokinetics of JNT-517. All participants will receive a single dose of the 4 treatments listed in below, in a fasted or fed (high fat meal) state.
Treatment A - 150 mg IR tablets—fasted (reference)
Treatment B - 150 mg IR tablets—fed
Treatment C - 150 mg mini-tablets—fasted
Treatment D - 150 mg mini-tablets—fed

There will be a washout of 4 days post-dose between the periods.
The IR tablets will be administered with a glass of water. The mini-tablets will be administered with water or sprinkled onto applesauce or protein-free lemon pudding. Participants must not be supine for at least 30 minutes post-dose. To monitor adherence, participants will have to consume the tablets in the presence of site staff.

Intervention code [1] 331068 0
Treatment: Drugs
Comparator / control treatment
Comparator: Relative bioavailability of single 150-mg doses of 2 JNT-517 formulations (IR tablets vs mini-tablets) to be compared in either fasted or fed state.
Comparing relative bioavailability between:
- 150 mg mini-tablets-fasted vs 150 mg IR tablets-fasted
- 150 mg mini-tablets-fed vs 150 mg IR tablets-fed
IR tablets either fed or fasted will be the reference comparator, as it is known that there is no food effect for IR tablets from previous trials.
Control group
Active

Outcomes
Primary outcome [1] 341470 0
Comparative bioavailability of single oral doses of 2 JNT-517 formulations (150 mg IR tablets and 150 mg mini-tablets) in the fasted and fed states in healthy participants.
Timepoint [1] 341470 0
PK blood sampling times for each period will be at day 1 through day 16, at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10,12, 24, 36, 48, 72 hours postdose. Dosing will occur on days 1, 5, 9 and 13.
Secondary outcome [1] 447637 0
Safety, tolerability, and Adverse Events of 2 JNT-517 formulations (150 mg IR tablets and 150 mg mini-tablets) in the fasted and fed states in healthy participants. These will be assessed as a composite secondary outcome.
Timepoint [1] 447637 0
Adverse events: continuously from screening (Day -28 to -2) to Follow-up or Early Termination (between Day 19 and Day 24). 12-lead ECGs: screening (Day -28 to -2), admission (day -1) and Follow-up or Early Termination (between Day 19 and Day 24). Vital signs: screening (Day -28 to-2), admission (day -1), days 1, 4, 5, 8, 9, 12, 13, 16 and Follow-up or Early Termination (between Day 19 and Day 24). Clinical laboratory tests: screening (Day -28 to -2), admission (day-1), days 4, 8, 12, 16, and Follow-up or Early Termination (between Day 19 and Day 24). Treatment period will be Day 1 through Day 16. Assessed as a composite secondary outcome as above.

Eligibility
Key inclusion criteria
- Males and females 18 to 55 years of age, inclusive.
- Medically healthy with no clinically significant medical history, physical examination (PE). laboratory results, vital signs, or electrocardiograms (ECGs) at Screening and Admission (Day -1).
- Body mass index (BMI) of 18-40 kg/m2 and total body weight of greater than 40 kg (88 lbs).
- Non-smoker for at least 2 weeks prior to dosing and willing to abstain during the trial.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any acute or chronic medical condition that would prevent the participant from complying with the procedures or place the participant at risk if they participate in the trial.
- Positive for hepatitis B or C or human immunodeficiency virus (HIV).
- Any history of malignancy in the last 5 years, excluding non-melanoma skin cancer.
- Any history of liver disease.
- Any surgical or medical conditions that may affect investigational medicinal product (IMP) absorption, distribution, metabolism, or excretion.
- Estimated glomerular filtration rate (eGFR) of less than 90 mL/min/1.73 m2 by 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
- Participation in another investigational drug trial within 30 days or, if known, 5 half-lives of the investigational drug (whichever is longer).
- Alcohol consumption within 5 days of randomization and/or unwilling to abstain during the trial.
- Use of any medications that are inhibitors or inducers of cytochrome P450 (CYP)3A4 or inhibitors of the transporter P-glycoprotein (P-gp) within 4 weeks prior to randomization and unwilling and/or unable to avoid these medications throughout the treatment duration.
- Use of any medication that is a substrate of CYP3A4, or a substrate of the transporters P-gp, breast cancer resistance protein (BCRP), organic anion transporter 3 (OAT3), multidrug and toxin extrusion (MATE)1, or MATE2-K within 4 weeks prior to randomization and unwilling and/or unable to avoid these medications throughout the treatment duration.
- History of drug/alcohol abuse in the last year.

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



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-availability
Statistical methods / analysis
No formal sample size calculations will be performed for this trial. The planned sample size has been determined using accepted standards for Phase 1 pharmacokinetic (PK) trials, outside of statistical considerations. A sufficient number of participants will be enrolled to achieve 20 completed participants. The analysis sets are defined as follows: ? Safety analysis set: all participants who receive at least one treatment of IMP. ? PK analysis set: all participants who receive at least one treatment of IMP and have at least one postdose evaluable PK concentration.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/06/2025
Actual
Date of last participant enrolment
Anticipated
17/07/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27948 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 44141 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 318985 0
Commercial sector/Industry
Name [1] 318985 0
Otsuka Pharmaceutical Development & Commercialization, Inc.
Country [1] 318985 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
CTI Clinical Trial and Consulting Services Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 321451 0
None
Name [1] 321451 0
Address [1] 321451 0
Country [1] 321451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317588 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 317588 0
Ethics committee country [1] 317588 0
Australia
Date submitted for ethics approval [1] 317588 0
30/04/2025
Approval date [1] 317588 0
30/05/2025
Ethics approval number [1] 317588 0

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

Contacts
Principal investigator
Name 141510 0
Dr Ofer Gonen
Address 141510 0
Nucleus Network, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, Victoria, 3004
Country 141510 0
Australia
Phone 141510 0
+6138593 9801
Fax 141510 0
Email 141510 0
[email protected]
Contact person for public queries
Name 141511 0
Nucleus Network Melbourne
Address 141511 0
Nucleus Network, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, Victoria, 3004
Country 141511 0
Australia
Phone 141511 0
+6131800 243 733
Fax 141511 0
Email 141511 0
[email protected]
Contact person for scientific queries
Name 141512 0
Toby Vaughn
Address 141512 0
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC). 2440 Research Blvd. Rockville, Maryland 20850, United States.
Country 141512 0
United States of America
Phone 141512 0
+1 513 5050770
Fax 141512 0
Email 141512 0
[email protected]

Data sharing statement
Will the study consider sharing 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.