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

Study Identifier:

JNT517-201

ClinicalTrials.gov Identifier:

NCT06637514

EudraCT Identifier:

N/A

Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Contact Information:

844-687-8522 or [email protected]

Will Be Recruiting

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Study Details

Medical Condition

Phenylketonuria (PKU)

Study Drug

Drug: JNT-517 Tablet

Date

Jul 2025 - Dec 2025

Phase 1/2

Phase 2/3

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 12 - 17 Years

Requirements Information

Protocol 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

Study Locations

No locations found.