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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT07525960
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Diabetes Insipidus

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • NDI-5001 — DRUG
    Capsule.

Study Details

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.

Key Dates

First listed
Apr 13, 2026
Start date
Jul 7, 2026
Status verified
Jul 2026
Primary completion
Aug 25, 2027
Completion
Aug 25, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NDI-5001
    Participants receive NDI-5001, orally, once daily (QD), for 9 consecutive days starting on Day 1.

Primary Outcome Measure

Percentage Change From Baseline in 24-Hour Urine Volume (Uvol) [ Time Frame: Up to Day 10 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Flourish JacksonvilleJacksonvilleFlorida32277
Chebib
[email protected]
844-687-8522
Flourish San AntonioSan AntonioTexas78023
Denham
[email protected]
844-687-8522

Find similar trials in Jacksonville, FL

By research site
Flourish Jacksonville· Jacksonville, FLFlourish San Antonio· San Antonio, TX

Related Studies