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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
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
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.
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
Key Details
Gender
MALE
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-07-07
Completion Date
2027-08-25
Last Updated
2026-07-17
Healthy Volunteers
No
Conditions
Interventions
NDI-5001
Capsule.
Locations (2)
Flourish Jacksonville
Jacksonville, Florida, United States
Flourish San Antonio
San Antonio, Texas, United States