Clinical Trial

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

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 4 changes
critical Enrollment reopened 2026-08-01
critical Trial status changed: Not Yet Recruiting → Active, Not Recruiting 2026-07-19
notable Primary completion pushed: 2027-04-14 -> 2027-08-25 2026-07-19
minor Completion pushed: 2027-04-14 -> 2027-08-25 2026-07-19
Trial Details
NCT Number NCT07525960
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions Diabetes Insipidus
Enrollment 24 participants
Start Date 2026-07-07
Primary Completion 2027-08-25 (estimated)
Study Completion 2027-08-25 (estimated)
Updated on ClinicalTrials.gov 2026-07-31