[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611488":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":78,"collaborators":24,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":24,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":24,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":24,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Agios Pharmaceuticals, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: AG-181","EXPERIMENTAL","Subjects will receive AG-181 from Day 1 to Day 28.",[13],"Drug: AG-181",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2 (Optional Cohort): AG-181","Subjects will receive AG-181.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","AG-181","AG-181 film-coated tablets",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Agios Medical Affairs","CONTACT","833-228-8474","medinfo@agios.com",[32,46,56,66],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":24},"Indiana University","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-86.15804,39.76838,{"lat":44,"lon":43},{"facility":47,"status":34,"city":48,"state":49,"zip":50,"country":38,"countryCode":39,"cosmosGeoPoint":51,"geoPoint":55,"contacts":24},"UPMC Children's Hospital of Pittsburgh","Pittsburgh","Pennsylvania","15224",{"type":41,"coordinates":52},[53,54],-79.99589,40.44062,{"lat":54,"lon":53},{"facility":57,"status":34,"city":58,"state":59,"zip":60,"country":38,"countryCode":39,"cosmosGeoPoint":61,"geoPoint":65,"contacts":24},"University of Texas Southwestern Medical Center (UTSW)","Dallas","Texas","75390",{"type":41,"coordinates":62},[63,64],-96.80667,32.78306,{"lat":64,"lon":63},{"facility":67,"status":34,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":77,"contacts":24},"Centrum Wsparcia Badań Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie","Szczecin","West Pomeranian Voivodeship","71-252","Poland","PL",{"type":41,"coordinates":74},[75,76],14.55302,53.42894,{"lat":76,"lon":75},{"type":79,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100611488","phase-1-a-study-to-evaluate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-ag-181-in-subjects-with-phenylketonuria-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":91,"type":92},20,"ESTIMATED","INTERVENTIONAL",[95],"PHASE1","The primary purpose of this study is to assess the safety and tolerability of AG-181 in subjects with Phenylketonuria (PKU).",[98],"Phenylketonuria","2026-06-19",{"date":101,"type":102},"2026-06-23","ACTUAL",{"date":104,"type":102},"2026-04-17",{"date":106,"type":92},"2028-01-17",{"name":5,"class":6},4]