A Phase 2 Study of JNT-517 in Adolescent Participants With Phenylketonuria
Status:
RECRUITING
Trial end date:
2026-02-01
Target enrollment:
Participant gender:
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
Phase:
PHASE2
Details
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.