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
Condition(s) studied
Investigational drug(s) / intervention(s)
NDI-5001: Capsule.
Study 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.
Eligibility
Primary outcome measure(s)
- Percentage Change From Baseline in 24-Hour Urine Volume (Uvol) — Up to Day 10
- Percentage Change From Baseline in Spot Urine Osmolality (Uosm) — Up to Day 10
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| NRC Research Institute | Santa Ana | California | Not Yet Recruiting |
| Flourish Jacksonville | Jacksonville | Florida | Recruiting |
| Flourish San Antonio | San Antonio | Texas | Recruiting |
More Otsuka Pharmaceutical Development & Commercialization, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07525960 on ClinicalTrials.gov ↗ ← All trials in the USA