[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599122":3},{"organization":4,"outcomesModule":7,"designInfo":71,"detailedDescription":11,"studyPopulation":11,"armGroups":77,"interventions":84,"overallOfficials":89,"centralContacts":93,"locations":99,"responsibleParty":164,"collaborators":11,"id":166,"slug":167,"hasResults":168,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":168,"sex":174,"minAge":175,"maxAge":176,"enrollmentInfo":177,"targetDuration":11,"studyType":180,"phases":181,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":102,"whyStopped":11,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"Calcilytix Therapeutics, Inc., a BridgeBio company","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Period 1: Maximum Plasma Concentration (Cmax) of Encaleret and Metabolites M1, and M3",null,"5 days",{"measure":14,"description":11,"timeFrame":12},"Period 1: Area Under the Plasma Concentration-time Curve (AUC) of Encaleret and Metabolites M1, and M3",{"measure":16,"description":11,"timeFrame":17},"Period 3: Number of Participants with Albumin-corrected Blood Calcium (cCa) and Urinary Calcium (UCa) Excretion Response","Week 25",[19,22,24,26,28,30,32,34,37,39,41,43,46,49,51,54,57,59,61,63,65,67,69],{"measure":20,"description":11,"timeFrame":21},"Period 1: Change from Baseline in Blood cCa","Baseline up to Day 5",{"measure":23,"description":11,"timeFrame":21},"Period 1: Change from Baseline in Blood Intact Parathyroid Hormone (iPTH) Concentration",{"measure":25,"description":11,"timeFrame":21},"Period 1: Change from Baseline in Blood Phosphate Concentration",{"measure":27,"description":11,"timeFrame":21},"Period 1: Change from Baseline in Blood 1,25-(OH)2 Vitamin D Concentration",{"measure":29,"description":11,"timeFrame":21},"Period 1: Change from Baseline in Blood Magnesium Concentration",{"measure":31,"description":11,"timeFrame":21},"Period 1: Change from Baseline in 24-hour UCa in Toilet Trained Participants",{"measure":33,"description":11,"timeFrame":21},"Period 1: Change from Baseline in Spot Ratio of UCa\u002FUrinary Creatinine (UCr) In Non-toilet Trained Participants",{"measure":35,"description":11,"timeFrame":36},"Period 3: Number of Participants with Blood iPTH Within the Reference Range","Week 25 (post-dose)",{"measure":38,"description":11,"timeFrame":17},"Period 3: Number of Participants with Blood Phosphate Within the Reference Range",{"measure":40,"description":11,"timeFrame":17},"Period 3: Number of Participants with Blood Magnesium Within the Reference Range",{"measure":42,"description":11,"timeFrame":17},"Period 3: Number of Participants with Blood 1,25-(OH)2 Vitamin D Within the Reference Range",{"measure":44,"description":11,"timeFrame":45},"Periods 1, 2, and 3: Change from Baseline in Short Form-10 Health Survey for Children (SF-10) in Participants Aged ≥6 Years","Baseline up to Week 25",{"measure":47,"description":11,"timeFrame":48},"Periods 1, 2, and 3: Dose of Calcium Supplements and\u002For Active Vitamin D Analogs Used as Rescue Therapy","25 weeks",{"measure":50,"description":11,"timeFrame":48},"Periods 1, 2, and 3: Dosing Frequency of Calcium Supplements and\u002For Active Vitamin D Analogs Used as Rescue Therapy",{"measure":52,"description":11,"timeFrame":53},"Periods 1, 2, 3, and LTE: Number of Participants with Adverse Events (AEs) and Serious AEs (SAEs)","145 weeks",{"measure":55,"description":11,"timeFrame":56},"LTE: Change from Baseline in Blood cCa","Baseline up to 145 weeks",{"measure":58,"description":11,"timeFrame":56},"LTE: Change from Baseline in Blood iPTH Concentration",{"measure":60,"description":11,"timeFrame":56},"LTE: Change from Baseline in Blood Phosphate Concentration",{"measure":62,"description":11,"timeFrame":56},"LTE: Change from Baseline in Blood 1,25-(OH)2 Vitamin D Concentration",{"measure":64,"description":11,"timeFrame":56},"LTE: Change from Baseline in Blood Magnesium Concentration",{"measure":66,"description":11,"timeFrame":56},"LTE: Change from Baseline in 24-hour UCa In Toilet Trained Participants",{"measure":68,"description":11,"timeFrame":56},"LTE: Change from Baseline in Spot Ratio of UCa\u002FUCr In Non-toilet Trained Participants",{"measure":70,"description":11,"timeFrame":56},"LTE: Change from Baseline in SF-10 in Participants Aged ≥6 Years",{"allocation":72,"interventionModel":73,"interventionModelDescription":11,"primaryPurpose":74,"observationalModel":11,"timePerspective":11,"maskingInfo":75},"NA","SEQUENTIAL","TREATMENT",{"masking":76,"maskingDescription":11,"whoMasked":11},"NONE",[78],{"label":79,"type":80,"description":81,"interventionNames":82},"Encaleret","EXPERIMENTAL","Participants will receive encaleret dosing in Period 1 (6 days), Period 2 (20 weeks) and Period 3 (4 weeks). Following completion of Period 3, participants will have the option to enter a long-term extension (LTE) to continue encaleret for an additional approximately 24 months or until the sponsor decides to end the study, whichever occurs first.",[83],"Drug: Encaleret",[85],{"type":86,"name":79,"description":87,"armGroupLabels":88,"otherNames":11},"DRUG","Oral tablets, age-appropriate pediatric formulation (currently under development).",[79],[90],{"name":91,"affiliation":5,"role":92},"Calcilytix Medical Director","STUDY_DIRECTOR",[94],{"name":95,"role":96,"phone":97,"phoneExt":11,"email":98},"Medical Information","CONTACT","650-600-3610","MedInfo@bridgebio.com",[100,114,124,134,144,155],{"facility":101,"status":102,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":11},"Yale University","RECRUITING","New Haven","Connecticut","06511","United States","US",{"type":109,"coordinates":110},"Point",[111,112],-72.92816,41.30815,{"lat":112,"lon":111},{"facility":115,"status":102,"city":116,"state":117,"zip":118,"country":106,"countryCode":107,"cosmosGeoPoint":119,"geoPoint":123,"contacts":11},"Children's National Medical Center","Washington D.C.","District of Columbia","20010",{"type":109,"coordinates":120},[121,122],-77.03637,38.89511,{"lat":122,"lon":121},{"facility":125,"status":102,"city":126,"state":127,"zip":128,"country":106,"countryCode":107,"cosmosGeoPoint":129,"geoPoint":133,"contacts":11},"Nemours Children's Health","Jacksonville","Florida","32207",{"type":109,"coordinates":130},[131,132],-81.65565,30.33218,{"lat":132,"lon":131},{"facility":135,"status":102,"city":136,"state":137,"zip":138,"country":106,"countryCode":107,"cosmosGeoPoint":139,"geoPoint":143,"contacts":11},"The Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":109,"coordinates":140},[141,142],-75.16362,39.95238,{"lat":142,"lon":141},{"facility":145,"status":102,"city":146,"state":11,"zip":147,"country":148,"countryCode":149,"cosmosGeoPoint":150,"geoPoint":154,"contacts":11},"Royal London Hospital","London","E1 1FR","United Kingdom","UK",{"type":109,"coordinates":151},[152,153],-0.12574,51.50853,{"lat":153,"lon":152},{"facility":156,"status":102,"city":157,"state":11,"zip":158,"country":148,"countryCode":149,"cosmosGeoPoint":159,"geoPoint":163,"contacts":11},"Royal Manchester Children's Hospital","Manchester","M13 9WL",{"type":109,"coordinates":160},[161,162],-2.23743,53.48095,{"lat":162,"lon":161},{"type":165,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100599122","phase-2-pharmacokinetics-efficacy-and-safety-of-encaleret-in-pediatric-participants-with-autosomal-dominant-hypocalcemia-type-1-adh1-100599122",false,"NCT07080385","Pharmacokinetics, Efficacy, and Safety of Encaleret in Pediatric Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)","A Phase 2\u002F3, Multicenter, Single-Arm, Open-Label Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Encaleret in Pediatric Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)","CALIBRATE-PEDS","Key Inclusion Criteria:\n\n* Provide written informed consent (if legally permitted), or have written informed consent from a parent\u002Flegal guardian and provide assent (where required and as appropriate per local requirements)\n* Have a documented pathogenic or likely pathogenic activating variant, or variant of uncertain significance of the calcium-sensing receptor (CASR), associated with biochemical findings of hypoparathyroidism at screening or a documented history of hypoparathyroidism as manifested by hypocalcemia and intact parathyroid hormone (PTH) \\\u003C40 picogram per milliliter (pg\u002FmL) (4.2 picomoles per liter \\[pmol\u002FL\\])\n* Have at least 1 symptom or sign of hypoparathyroidism at screening or a documented history of symptoms or signs of hypoparathyroidism\n* Be on ADH1 treatment for at least 6 months before screening for cohorts 1 to 3, or for at least 3 months before screening for cohort 4\n\nKey Exclusion Criteria:\n\n* History of thyroid or parathyroid surgery\n* History of renal transplantation\n* History of cancer (except thyroid cancer, basal cell skin cancer, or squamous cell skin cancer), skeletal malignancies, bone metastases, irradiation (radiotherapy) to the skeleton, chemotherapy with alkylating agents, Paget disease, fibrous dysplasia, chronic osteomyelitis, bone infarcts, benign bone tumors with curettage and bone grafts, retinoblastoma, or Li-Fraumeni syndrome within 5 years before screening\n* Received any investigational medicinal product within 30 days or 5 half-lives before Day 1, whichever is longer, or is in follow-up for another interventional clinical study during screening\n* Treatment with a strong P-glycoprotein (P-gp) inhibitor within 300 days before screening for amiodarone or within 30 days before screening for any other strong P-gp inhibitor\n* Treatment with cardiac glycosides, or is being breastfed while the participant's nursing mother is treated with cardiac glycosides, within 30 days before screening\n* Presence or history of any disease or condition (eg, drug or alcohol dependence) that would affect the participant's safety, treatment compliance, or ability to complete the study, in the opinion of the investigator\n\nOther protocol defined inclusion\u002Fexclusion criteria apply.","ALL","0 Years","17 Years",{"count":178,"type":179},28,"ESTIMATED","INTERVENTIONAL",[182,183],"PHASE2","PHASE3","The overall objective of this study is to evaluate the pharmacokinetics (PK), efficacy, and safety of encaleret in pediatric participants from birth to 17 years of age with ADH1.",[186],"Autosomal Dominant Hypocalcemia Type 1 (ADH1)",[188,189,79],"Autosomal dominant hypocalcemia type 1","ADH1","2026-04-20",{"date":192,"type":193},"2026-04-22","ACTUAL",{"date":195,"type":193},"2026-01-30",{"date":197,"type":179},"2030-12",{"name":5,"class":6},6]