Not Yet RecruitingPhase 1ACTRN12625000641493

A Trial to Examine the Amount of JNT-517 Entering the Bloodstream and the Effect of Food on Different Formulations of JNT-517

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

Sponsor

CTI Clinical Trial and Consulting Services Australia Pty Ltd

Enrollment

24 participants

Start Date

Jun 23, 2025

Study Type

Interventional

Conditions

Phenylketonuria

Summary

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 (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 in a fasted or fed (high fat meal) state.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria4

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.

Exclusion Criteria11

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.

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Interventions

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.