Phase 3 Phenylketonuria Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with phenylketonuria (PKU), confirmed by genetic testing or blood test results
• You are 4 years old or older at the time of initial screening
• You have not taken the medication pegvaliase in the 4 weeks before screening
• You have not taken the medication sepiapterin in the 2 weeks before screening
• If you are currently taking sapropterin or large neutral amino acids, your dose has been stable for at least 4 weeks before screening
• You are willing and able to keep your diet consistent in phenylalanine (Phe) content throughout the study, unless a dietician advises otherwise as allowed by the study
• You weigh at least 12.5 kg (about 27.5 lbs)
• If you are a woman who could become pregnant, you must have a negative pregnancy test before starting, use two forms of contraception (at least one highly effective) from screening until 30 days after your last dose, and not donate eggs during the study or for 30 days after your last dose
• If you are a woman who cannot become pregnant (due to surgery, menopause for at least 1 year confirmed by a hormone test, or not yet having had your first period), you meet the study's requirements for this category
• If you are a man, you must either abstain from sex that could lead to pregnancy or use two forms of contraception (at least one highly effective) from the first dose until 30 days after the last dose, and not donate sperm during this time (men with a documented vasectomy done at least 4 months before screening do not need to follow these steps)
• You (or your parent/guardian, if you are a child) are able to give informed consent and follow the study procedures
• If you have a psychiatric (mental health) condition, it has been well-controlled for the past 3 months, and if you take medication for it, that medication dose has been stable for the past 3 months

Who may not be able to join:

• The study doctor feels that joining the study would not be safe or practical for you
• You are eligible for another active study of the same drug (JNT-517) at the same site and have not completed a previous JNT-517 study, unless special permission is given
• You have any ongoing or long-term health condition that could prevent you from following study procedures or could put you at risk
• You have tested positive for hepatitis B, hepatitis C, or HIV
• You have a history of significant liver disease
• You have a history of cataracts, or more than very minor cataracts were found during your eye exam at screening
• You have had surgery or have a medical condition that could affect how the study drug is absorbed or processed by your body
• Your kidneys are not functioning well enough, based on a specific blood test result (confirm with trial site)
• You have had a problem with drug or alcohol misuse in the past year
• You are taking certain medications that affect how the liver processes drugs (called CYP3A4 inhibitors/inducers or P-gp inhibitors) within 4 weeks before your first dose, and you are unwilling or unable to stop taking them during the study
• You are taking certain other specific medications within 4 weeks before your first dose and are unwilling or unable to stop them during the study (confirm with trial site for the full list)
• You have had, or are suspected of having, COVID-19 within 2 weeks of screening
• You are unable to swallow tablets or take oral medication
• You have a known allergy to the study drug (JNT-517) or any of its ingredients
• Certain blood test results at screening fall outside acceptable ranges, including markers of liver function, red blood cell levels, white blood cell count, or platelet count (confirm with trial site for specific values)
• You have taken part in another clinical drug trial within the past 30 days (studies of JNT-517 may be an exception)

Important: Always verify eligibility with the trial site directly before applying.