clinical 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
Otsuka Pharmaceutical Development & Commercialization, Inc.·phase1·not yet recruiting·n = 24
X-linked Congenital Nephrogenic Diabetes InsipidusNDI-5001
brief 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.
started
Jun 2, 2026
primary completion
Apr 14, 2027
completion
Apr 14, 2027
last updated
Apr 13, 2026
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol