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A Phase 2 Study of JNT-517 in Adolescent Participants With Phenylketonuria

NCT06637514 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-05-13

No results posted yet for this study

Summary

The goal of this Phase 2, randomized study is to assess the safety, tolerability, and pharmacokinetics (PK) of oral JNT-517 in adolescents (12 to less than 18 years of age) with PKU. Participants will receive either JNT-517 or placebo and will be blinded to their treatment assignment. Participants will have a 4 in 5 (or 80%) chance of receiving JNT-517. The study will last for up to 63 days including a Screening period, Treatment period and Follow-up period for safety.

Participants will:

* Take 75 mg JNT-517 or a placebo BID (2x per day) for 28 days
* Visit the clinic or have a mobile health nurse visit your home for checkups and tests
* Collect urine sample at home and bring to clinic on specified days
* Keep a food diary 3 days before each study visit

Conditions

  • Phenylketonuria (PKU)

Interventions

DRUG

JNT-517 Tablet

JNT-517: 75 mg BID

OTHER

Placebo

Placebo Tablet: BID

DRUG

JNT-517 Tablet

JNT-517: 150 mg BID

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-16
Primary Completion
2026-05-08
Completion
2026-05-08
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06637514 on ClinicalTrials.gov