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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NDI-5001 | Unknown | — | Oral |