Phase 3 Phenylketonuria Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older who have been diagnosed with PKU (phenylketonuria)
• People whose blood phenylalanine (Phe) levels average 360 μmol/L or higher (measured after fasting for more than 4 hours) during the screening period
• People who have not used the medication pegvaliase in the 4 weeks before screening
• People who are currently taking sapropterin or large neutral amino acids (such as PheBloc®, NeoPhe®, or PreKunil®), provided the dose has been stable for at least 4 weeks before screening and can stay the same throughout the study
• People who are able and willing to keep their diet consistent in terms of phenylalanine and protein intake, and to make dietary adjustments as guided throughout the study
• People who weigh more than 40 kilograms
• Women who could become pregnant must have a negative pregnancy test at screening and again by the first day of the study, and must agree to use 2 highly effective forms of contraception (or remain abstinent) from screening until at least 30 days after the last dose of study medication; they must also agree not to donate eggs during the study and for 30 days after the last dose
• Women who are not able to become pregnant — including those who have had a hysterectomy, removal of both ovaries or both fallopian tubes, or who have had no periods for at least 1 year (confirmed by a hormone test), or who have never started menstruating — may also be eligible
• Biological males must agree to use highly effective contraception (or remain abstinent) from the first day of the study until at least 30 days after the last dose, and must not donate sperm during this time (note: men with a documented vasectomy performed at least 4 months before screening do not need to follow these steps)
• People with a mental health condition may still be eligible if their condition has been well managed for at least the past 6 months, and if they are on medication for it, that medication has been stable for at least the past 3 months
• People who are able to give their own signed consent, or whose parent or legal guardian can provide consent on their behalf, and who are able to follow the study procedures

Who may not be able to join:

• People with any serious ongoing or uncontrolled health condition that could interfere with study participation or put them at risk
• People who test positive for hepatitis B, hepatitis C, or HIV
• People who have had any cancer (other than certain non-serious skin cancers or early-stage cervical cancer) in the past 5 years
• People with any history of significant liver disease
• People with a history of cataracts, or who are found to have more than very minor cataracts during an eye exam at screening
• People with any surgical or medical conditions that could affect how the study drug is processed by the body
• People whose kidneys are not functioning well enough, based on a specific blood test result (confirm with trial site)
• People who have taken part in another clinical drug trial within the past 30 days (or longer, depending on the drug); for gene therapy trials, participation must have ended more than 6 months before screening, with stable Phe levels for at least 2 months before screening
• People who have consumed alcohol within 5 days before being assigned to a treatment group, or who are unwilling to limit alcohol to no more than one drink per day until after the 6-month study visit
• People with a history of drug or alcohol misuse in the past year
• People currently taking certain medications that affect how drugs are broken down or transported in the body (specific drug types include CYP3A4 inhibitors or inducers, and P-glycoprotein inhibitors), if they are unwilling or unable to stop taking them during the study
• People currently taking certain other medications that interact with specific transport proteins in the body (BCRP, MATE1, or MATE2-K substrates), if they are unwilling or unable to stop taking them during the study
• People who have had, or are currently suspected of having, an active viral or bacterial infection within 2 weeks before or during the screening period
• People who are unable to swallow oral medication or have a condition that would prevent the study drug from being properly absorbed
• People who are allergic to the study drug (JNT-517) or any of its ingredients
• People whose blood test results at screening fall outside acceptable ranges for liver enzymes, bilirubin, haemoglobin, white blood cell count, or platelets (confirm specific values with trial site)

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