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NCT06637514 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of JNT-517 in Adolescent Participants With Phenylketonuria
A Phase 2 study of Phenylketonuria (PKU), sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06637514: Recruiting Phase 2 study of Phenylketonuria (PKU), sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT06637514 is a Phase 2 study of Phenylketonuria (PKU) that is actively recruiting participants, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 10 participants, below the 181-participant average among 6 other Phenylketonuria (PKU) trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06637514, a Phase 2 study of Phenylketonuria (PKU), is actively recruiting participants, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
Reported based on results of 12-lead electrocardiograms (ECGs), vital signs and clinical laboratory tests.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG JNT-517 Tablet
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-07-16 |
| Est. Completion | 2026-02 |
| Phase | Phase 2 |
What NCT06637514 shows while recruiting
NCT06637514 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 181-participant average among 6 other Phenylketonuria (PKU) trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Phenylketonuria (PKU) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06637514 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06637514 about?
NCT06637514 is a clinical study titled "A Phase 2 Study of JNT-517 in Adolescent Participants With Phenylketonuria". 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 w...
What is the current status of trial NCT06637514?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2025-07-16. Estimated completion is 2026-02.
What conditions does trial NCT06637514 study?
This clinical trial studies the following conditions: Phenylketonuria (PKU).
What interventions are being tested in trial NCT06637514?
The interventions under investigation include: Placebo (OTHER), JNT-517 Tablet (DRUG).
Who is sponsoring clinical trial NCT06637514?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06637514 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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