[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633382":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":11,"studyPopulation":11,"armGroups":60,"interventions":67,"overallOfficials":11,"centralContacts":72,"locations":11,"responsibleParty":78,"collaborators":11,"id":80,"slug":11,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":11,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":11,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":11,"overallStatus":98,"whyStopped":11,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":11},{"fullName":5,"class":6},"Otsuka Pharmaceutical Development & Commercialization, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percentage Change From Baseline in 24-Hour Urine Volume (Uvol)",null,"Up to Day 10",{"measure":14,"description":11,"timeFrame":12},"Percentage Change From Baseline in Spot Urine Osmolality (Uosm)",[16,18,20,22,24,26,28,30,33,36,38,40,42,45,47,50,52],{"measure":17,"description":11,"timeFrame":12},"Change From Time-Matched Baseline in Uvol",{"measure":19,"description":11,"timeFrame":12},"Change From Time-Matched Baseline in Uosm",{"measure":21,"description":11,"timeFrame":12},"Change From Baseline in 24-Hour Uosm",{"measure":23,"description":11,"timeFrame":12},"Correlation Coefficient Between 24-Hour Uvol and Uvol by interval",{"measure":25,"description":11,"timeFrame":12},"Correlation Coefficient Between 24-Hour Uvol and Uosm by Interval",{"measure":27,"description":11,"timeFrame":12},"Correlation Coefficient Between 24-Hour Uvol and Spot Uosm",{"measure":29,"description":11,"timeFrame":12},"Correlation Coefficient Between Change From Baseline in Uvol and Change From Baseline in Uosm by Interval",{"measure":31,"description":11,"timeFrame":32},"Number of Participants With Adverse Events (AEs)","Up to Day 39",{"measure":34,"description":11,"timeFrame":35},"Number of Participants With Clinically Relevant Changes in Clinical Laboratory Values","Up to Day 31",{"measure":37,"description":11,"timeFrame":35},"Number of Participants With Potentially Clinically Relevant Changes in Vital Signs",{"measure":39,"description":11,"timeFrame":12},"Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings",{"measure":41,"description":11,"timeFrame":12},"Number of Participants With Potentially Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Parameters",{"measure":43,"description":11,"timeFrame":44},"Maximum (Peak) Plasma Concentration (Cmax) of NDI-5001","Day 1 and Day 9",{"measure":46,"description":11,"timeFrame":44},"Time to Reach Maximum (Peak) Observed Plasma Concentration (Tmax) of NDI-5001",{"measure":48,"description":11,"timeFrame":49},"Area Under the Concentration-time Curve From Time Zero to 24 hours (AUC0-24h) of NDI-5001","Up to 24 hours, post dose on Day 1 and Day 9",{"measure":51,"description":11,"timeFrame":44},"Dose-Normalized Maximum Observed Plasma Concentration (Cmax\u002FDose) of NDI-5001",{"measure":53,"description":11,"timeFrame":49},"Dose-Normalized Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24h\u002FDose) of NDI-5001",{"allocation":55,"interventionModel":56,"interventionModelDescription":11,"primaryPurpose":57,"observationalModel":11,"timePerspective":11,"maskingInfo":58},"NA","SINGLE_GROUP","TREATMENT",{"masking":59,"maskingDescription":11,"whoMasked":11},"NONE",[61],{"label":62,"type":63,"description":64,"interventionNames":65},"NDI-5001","EXPERIMENTAL","Participants receive NDI-5001, orally, once daily (QD), for 9 consecutive days starting on Day 1.",[66],"Drug: NDI-5001",[68],{"type":69,"name":62,"description":70,"armGroupLabels":71,"otherNames":11},"DRUG","Capsule.",[62],[73],{"name":74,"role":75,"phone":76,"phoneExt":11,"email":77},"Otsuka Call Center","CONTACT","844-687-8522","otsukaprofessionalservices@otsuka-us.com",{"type":79,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":90,"type":91},24,"ESTIMATED","INTERVENTIONAL",[94],"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.",[97],"X-linked Congenital Nephrogenic Diabetes Insipidus","NOT_YET_RECRUITING","2026-04-06",{"date":101,"type":102},"2026-04-13","ACTUAL",{"date":104,"type":91},"2026-06-02",{"date":106,"type":91},"2027-04-14",{"name":5,"class":6}]