[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"x-linked-congenital-nephrogenic-diabetes-insipidus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:x-linked-congenital-nephrogenic-diabetes-insipidus":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100633382","phase-1-a-study-in-adult-males-with-x-linked-congenital-nephrogenic-diabetes-insipidus-to-test-the-effects-of-ndi-5001-given-for-multiple-days-and-to-test-how-ndi-5001-is-tolerated-and-taken-up-in-the-body-100633382",false,"NCT07525960","A Study in Adult Males With X-linked Congenital Nephrogenic Diabetes Insipidus to Test the Effects of NDI-5001 Given for Multiple Days and to Test How NDI-5001 is Tolerated and Taken up in the Body","A Phase 1b, Open-label Trial to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of NDI-5001 in a Capsule Following Daily Oral Doses to Adult Males With X-linked Congenital Nephrogenic Diabetes Insipidus","Inclusion Criteria\n\n1. X-linked congenital NDI with a genotype-confirmed arginine vasopressin receptor 2 (gene) (AVPR2) mutation and no mutation in aquaporin-2 (AQP2).\n2. Urine osmolality of ≤ 200 milliosmoles per kilogram of water (mOsm\u002Fkg) in a spot urine sample obtained from a first morning void upon awakening (at screening, check-in \\[Day -4\\], and Day -1) before consuming any food or drink after awakening.\n\n3\\) BMI between 18.0 to 32.0 kilograms per square meter (kg\u002Fm\\^2), inclusive.\n\nExclusion Criteria\n\n1. Participant who is not willing to follow a low-sodium (\\\u003C=1 gram\u002Fday) diet during the in-clinic portion of the trial.\n2. A positive drug screen for substances of abuse (including THC, cannabidiol) at screening or check-in.\n3. Estimated glomerular filtration rate \\\u003C60 milliliters per minute per 1.73-kilogram square meters by serum creatinine and cystatin C at screening.\n4. Participants who have taken an investigational drug within 30 days prior to screening.\n5. Previous exposure to NDI-5001.\n6. Any history of significant bleeding or hemorrhagic tendencies.\n\nNote: Other protocol-specified inclusion\u002Fexclusion criteria may apply.","MALE","18 Years","55 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The primary purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NDI-5001 administered as a capsule following daily oral dosing in adult males with X-linked congenital nephrogenic diabetes insipidus (NDI) due to vasopressin receptor Type 2 (V2R) mutations.",[27],"X-linked Congenital Nephrogenic Diabetes Insipidus","NOT_YET_RECRUITING","2026-04-06",{"date":31,"type":32},"2026-04-13","ACTUAL",{"date":34,"type":21},"2026-06-02",{"date":36,"type":21},"2027-04-14",{"name":38,"class":39},"Otsuka Pharmaceutical Development & Commercialization, Inc.","INDUSTRY"]