Actively Recruiting
Phase 1b Trial Evaluating Daily NDI-5001 Capsules in Adult Males With X-linked Congenital Nephrogenic Diabetes Insipidus
Led by Otsuka Pharmaceutical Development & Commercialization, Inc. · Updated on 2026-07-31
24
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of NDI-5001 capsules in adult males with X-linked congenital nephrogenic diabetes insipidus caused by vasopressin receptor Type 2 mutations. This study focuses on how the body absorbs and responds to NDI-5001 given daily, aiming to better understand its effects in this specific condition. Participants will take NDI-5001 orally once daily for nine consecutive days. The study includes only one treatment group receiving the investigational drug. The trial monitors urine volume and osmolality changes to assess drug effects up to day 10. Safety assessments continue through day 31 or 39 for laboratory tests, vital signs, physical exams, and electrocardiograms. During the study, participants will undergo urine sample collections, blood tests, and clinical evaluations before and during treatment. Researchers will measure urine volume and concentration changes, drug levels in the blood, and monitor for any adverse events. The total participation time includes screening, a nine-day treatment period, and safety follow-up visits lasting up to 39 days from the start.
CONDITIONS
Brief Title
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
Research Team
O
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