[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611488":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":11,"studyPopulation":11,"armGroups":36,"interventions":47,"overallOfficials":11,"centralContacts":53,"locations":59,"responsibleParty":106,"collaborators":11,"id":108,"slug":11,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":11,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":11,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":11,"overallStatus":62,"whyStopped":11,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Agios Pharmaceuticals, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to the Study Drug",null,"Up to Day 42",[14,17,19,21,23,25,27],{"measure":15,"description":11,"timeFrame":16},"Plasma Concentration of AG-181","Up to Day 28",{"measure":18,"description":11,"timeFrame":16},"Maximum Concentration (Cmax) of AG-181",{"measure":20,"description":11,"timeFrame":16},"Time to Maximum (Peak) Concentration (Tmax) of AG-181",{"measure":22,"description":11,"timeFrame":16},"Area Under the Concentration-Time Curve (AUC) of AG-181",{"measure":24,"description":11,"timeFrame":16},"Apparent Total Body Clearance (CL\u002FF) of AG-181",{"measure":26,"description":11,"timeFrame":16},"Apparent Volume of Distribution in the Terminal Phase (Vz\u002FF) of AG-181",{"measure":28,"description":11,"timeFrame":29},"Change From Baseline in Phenylalanine (Phe) Concentration","Baseline up to Day 28",{"allocation":31,"interventionModel":32,"interventionModelDescription":11,"primaryPurpose":33,"observationalModel":11,"timePerspective":11,"maskingInfo":34},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":35,"maskingDescription":11,"whoMasked":11},"NONE",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Cohort 1: AG-181","EXPERIMENTAL","Subjects will receive AG-181 from Day 1 to Day 28.",[42],"Drug: AG-181",{"label":44,"type":39,"description":45,"interventionNames":46},"Cohort 2 (Optional Cohort): AG-181","Subjects will receive AG-181.",[42],[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"DRUG","AG-181","AG-181 film-coated tablets",[38,44],[54],{"name":55,"role":56,"phone":57,"phoneExt":11,"email":58},"Agios Medical Affairs","CONTACT","833-228-8474","medinfo@agios.com",[60,74,84,94],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":11},"Indiana University","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-86.15804,39.76838,{"lat":72,"lon":71},{"facility":75,"status":62,"city":76,"state":77,"zip":78,"country":66,"countryCode":67,"cosmosGeoPoint":79,"geoPoint":83,"contacts":11},"UPMC Children's Hospital of Pittsburgh","Pittsburgh","Pennsylvania","15224",{"type":69,"coordinates":80},[81,82],-79.99589,40.44062,{"lat":82,"lon":81},{"facility":85,"status":62,"city":86,"state":87,"zip":88,"country":66,"countryCode":67,"cosmosGeoPoint":89,"geoPoint":93,"contacts":11},"University of Texas Southwestern Medical Center (UTSW)","Dallas","Texas","75390",{"type":69,"coordinates":90},[91,92],-96.80667,32.78306,{"lat":92,"lon":91},{"facility":95,"status":62,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":11},"Centrum Wsparcia Badań Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie","Szczecin","West Pomeranian Voivodeship","71-252","Poland","PL",{"type":69,"coordinates":102},[103,104],14.55302,53.42894,{"lat":104,"lon":103},{"type":107,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100611488",false,"NCT07241234","A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-181 in Subjects With Phenylketonuria","A Phase 1b, Open-label, Multicenter, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of AG-181 in Subjects With Phenylketonuria","Key Inclusion Criteria:\n\n* Diagnosis of PKU, defined as documented presence of 2 mutant alleles in the phenylalanine hydroxylase (PAH) gene, of which at least 1 is the R408W mutation, as determined during Screening per the genotyping performed by the study central genotyping laboratory.\n* At least 1 plasma Phe concentration greater than (\\>) 600 micromoles per liter (μmol\u002FL) in the 52 weeks before providing informed consent.\n* Average concentration of plasma Phe \\> 600 μmol\u002FL in Phe samples taken during Screening, with no individual assessment below 360 μmol\u002FL. Any Phe samples taken after Day -20 will not be included.\n* Body mass index (BMI) greater than or equal to (≥) 18.0 kilograms per meter square (kg\u002Fm\\^2) to lesser than or equal to (≤) 35.0 kg\u002Fm\\^2 and weight ≥ 50 kilograms (kg) at any time during the Screening Period.\n* Documented approval from a dietitian confirming that the subject can maintain their diet consistent in protein and Phe intake throughout the study as outlined in the Diet Manual.\n\nKey Exclusion Criteria:\n\n* Prior exposure to AG-181.\n* Receiving inhibitors of P-glycoprotein (P-gp) that have not been stopped for ≥ 5 days or a timeframe equivalent to 5 half-lives (whichever is longer) before administration of the first dose of study drug.\n* Receiving products that are strong inhibitors or strong inducers of cytochrome P450 CYP1A2, CYP2C8, or CYP3A that have not been stopped for ≥ 28 days before administration of the first dose of study drug.\n* Receiving treatment with an acid-reducing agent, including but not limited to proton pump inhibitors and H2 blockers. Short-acting acid-reducing agents such as calcium carbonate are permitted.\n* Any preexisting condition that could (in the opinion of the Investigator) interfere with gastrointestinal anatomy or motility that may disrupt the absorption, metabolism, and\u002For excretion of the study drug.\n* Any preexisting condition that could (in the opinion of the Investigator) interfere with hepatic or renal function that may disrupt the absorption, metabolism, and\u002For excretion of the study drug.\n* Inability to tolerate oral medication.\n* Unwillingness to washout from tetrahydrobiopterin (BH4) supplementation (eg, sapropterin dihydrochloride, Kuvan), pegvaliase-pqpz (Palynziq), or any other PKU therapy by Day -30 during Screening.","ALL","18 Years","69 Years",{"count":118,"type":119},20,"ESTIMATED","INTERVENTIONAL",[122],"PHASE1","The primary purpose of this study is to assess the safety and tolerability of AG-181 in subjects with Phenylketonuria (PKU).",[125],"Phenylketonuria","2026-06-19",{"date":128,"type":129},"2026-06-23","ACTUAL",{"date":131,"type":129},"2026-04-17",{"date":133,"type":119},"2028-01-17",{"name":5,"class":6},4]