Phase 1 Phenylketonuria Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Your Body Mass Index (BMI) is between 18 and 35 (a measure of body weight relative to height)
- You are male or female (assigned at birth), of any gender identity — note that one part of the trial (Arm 1) only recruits biological females who cannot become pregnant
- You are in good general health, confirmed through a review of your medical history, a physical exam, a heart tracing (ECG), and blood and urine tests
- You are willing to stay at the clinic for the required time and be contacted by phone for safety check-ins after the trial
- You are able to give written consent and, in the opinion of the lead doctor, are able to follow all trial requirements
Who may not be able to join:
- Female participants who are able to become pregnant
- Female participants (Arm 1 only) who have used hormone replacement therapy (HRT) in the last 60 days, or hormonal contraceptives in the last 14 days before the trial starts
- People who have a significant past or current health condition — such as heart, liver, kidney, nerve, hormone, digestive, breathing, blood, or immune system problems — that the doctor believes could affect safety or how the body processes the study drug (confirm with trial site)
- For one specific part of the trial (Arm 3), people who carry certain genetic markers (HLA-B*15:02, HLA-A*31:01, or HLA-B*15:11) linked to a serious reaction to a medicine called carbamazepine (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: 844-687-8522
Australian sites
844-687-8522
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
All Arms: Maximum Plasma Concentration (Cmax); All Arms: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Observable Concentration at Time t (AUCt); All Arms: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinfinity)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.