Clinical Trial

Phase I PK and Safety Study of Ondansetron Inhalation Powder

Completed Phase 1
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn if LPI-1503 (Ondansetron Inhalation Powder) can deliver ondansetron into blood through inhalation. It will also learn about the safety of LPI-1503. The main questions it aims to answer are: Does ondansetron enter into blood after inhalation of LPI-1503? And if it does, how efficiently? how rapidly? What medical problems do participants have when and after inhaling LPI-1503? Researchers will compare LPI-1503 to a placebo (a look-alike substance that contains no drug), and to orally swallowed and injected administrated ondansetron. Participants will: Visit site and take LPI-1503 or a placebo once by inhalation, followed by checkups and tests; and (if took LPI-1503 in visit 1) After one week, visit site again to take ondansetron by orally swallowing or by injection, followed by checkups and tests.
Trial Details
NCT Number NCT07498751
Lead Sponsor Luxena Pharmaceuticals, Inc.
Collaborators: Altasciences Company Inc.
Conditions Postoperative Nausea and Vomiting
Enrollment 24 participants
Start Date 2025-03-13
Primary Completion 2025-08-23 (estimated)
Study Completion 2025-08-23 (estimated)
Updated on ClinicalTrials.gov 2026-03-27