NCT07498751

Phase I PK and Safety Study of Ondansetron Inhalation Powder

Randomized, Double-Blind, Placebo-Controlled, Single-Dose, 3-Escalating Cohort, 2 Period Crossover Study Investigating the Tolerability, Safety, and Pharmacokinetics of Ondansetron Inhalation Powder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Luxena Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	LPI-1503	Micronized ondansetron blended with excipients, to be administrated by inhalation, by using a single-capsule inhaler RS01(R).
DRUG	Matching Placebo of LPI-1503	Powder that contains only excipient (no API), to be administrated by inhalation, by using a single-capsule inhaler RS01(R).
DRUG	IV Ondansetron	4mg Ondansetron to be administrated by IV as an active comparator in Period 2.
DRUG	Oral Ondansetron	8mg ondansetron to be orally administrated as an active comparator in Period 2.

Timeline

• Start date: 2025-03-13
• Primary completion: 2025-08-23
• Completion: 2025-08-23
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study