Condition: Phenylketonuria · Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
The goal of this Phase 3, randomized study is to assess the safety, efficacy, tolerability, and pharmacokinetics (PK) of oral JNT-517 in adults (18 years of age or older) with PKU. Participants will receive either JNT-517 or placebo and will be blinded to their treatment assignment. Participants will have a 2 in 3 (or approximately 67%) chance of receiving JNT-517 during the first part of the study which will last approximately six weeks. During the second part of the study every participant who continues in the study will receive one of two doses of JNT-517 for an additional 46 weeks. The study requires a screening period of up to 35 days to ensure dietary stabilization and amino acid levels required to meet study eligibility. In total, participation in the study could last for up to 400 days. Participants will: Take 75 mg JNT-517 or 150 mg JNT-517, or a placebo BID (2x per day) for approximately 365 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
This description comes directly from the study's public registry record.
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Always discuss trial participation with your own doctor first.
| University of California Los Angeles (UCLA) School of Medicine | Los Angeles, California, United States | Recruiting |
| University of Florida (UF) Health Shands Hospital | Gainesville, Florida, United States | Recruiting |
| University of South Florida | Tampa, Florida, United States | Recruiting |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago, Illinois, United States | Recruiting |
| Oregon Health and Science University | Portland, Oregon, United States | Recruiting |
| University of Pittsburgh Medical Center (UPMC) - Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania, United States | Recruiting |
| Vanderbilt University Medical Center | Nashville, Tennessee, United States | Recruiting |
| University of Texas Southwestern | Dallas, Texas, United States | Recruiting |
| University of Texas Health (UTHealth) Science Center at Houston | Houston, Texas, United States | Recruiting |
| Utah Health - The University of Utah Hospital | Salt Lake City, Utah, United States | Recruiting |
| Royal Adelaide Hospital | Adelaide, Australia | Recruiting |
| Royal Melbourne Hospital | Parkville, Australia | Recruiting |
+ 14 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06971731