[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633382":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":19,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":19,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":19,"overallStatus":47,"whyStopped":19,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":19},{"fullName":5,"class":6},"Otsuka Pharmaceutical Development & Commercialization, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NDI-5001","EXPERIMENTAL","Participants receive NDI-5001, orally, once daily (QD), for 9 consecutive days starting on Day 1.",[13],"Drug: NDI-5001",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Capsule.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Otsuka Call Center","CONTACT","844-687-8522","otsukaprofessionalservices@otsuka-us.com",{"type":27,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","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":39,"type":40},24,"ESTIMATED","INTERVENTIONAL",[43],"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.",[46],"X-linked Congenital Nephrogenic Diabetes Insipidus","NOT_YET_RECRUITING","2026-04-06",{"date":50,"type":51},"2026-04-13","ACTUAL",{"date":53,"type":40},"2026-06-02",{"date":55,"type":40},"2027-04-14",{"name":5,"class":6}]