drugset / Trial / 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

NCT07525960 ↗

Phase 1 Active not recruiting 24 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-07-07
Primary completion
2027-08-25
Completion
2027-08-25

Drugs

EvaluationDrugModalityDoseRoute
Subject NDI-5001 Unknown — Oral

Indications