CompletedPhase 1

Phase I PK and Safety Study of Ondansetron Inhalation Powder

Canada24 participantsStarted 2025-03-13

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision of signed and dated informed consent form (ICF).
. Subject is, as stated and in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study procedures and requirements, and is available for the duration of the study.
. Healthy adult male or female.
. Subject is willing to comply with the contraceptive requirements as defined in APPENDIX 6.
. Aged at least 18 years but not older than 55 years.
. Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively.
. Non-smokers or ex-smokers (an ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Treatment-Emergent Adverse Events

Timeframe: pre-dose to 48 hours post-dose or to end of all AEs (if any), whichever is later.

Number of Participants with Serious Adverse Events.

Timeframe: pre-dose to 48 hours post-dose or to end of all AEs (if any), whichever is later.

Number of Participants with Treatment-Related Adverse Events

Timeframe: pre-dose to 48 hours post-dose or to end of all AEs (if any), whichever is later.

Cmax

Timeframe: pre-dose to 48 hours post-dose

Tmax

Timeframe: pre-dose to 48 hours post-dose

AUC(0-t)

Timeframe: pre-dose to 48 hours post-dose

AUC(0-inf)

Timeframe: pre-dose to 48 hours post-dose

Trial details

NCT IDNCT07498751

SponsorLuxena Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-23

View on ClinicalTrials.gov More Postoperative Nausea and Vomiting trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision of signed and dated informed consent form (ICF).
. Subject is, as stated and in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study procedures and requirements, and is available for the duration of the study.
. Healthy adult male or female.
. Subject is willing to comply with the contraceptive requirements as defined in APPENDIX 6.
. Aged at least 18 years but not older than 55 years.
. Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively.
. Non-smokers or ex-smokers (an ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration).

What they're measuring

Number of Participants with Treatment-Emergent Adverse Events

Timeframe: pre-dose to 48 hours post-dose or to end of all AEs (if any), whichever is later.

Number of Participants with Serious Adverse Events.

Timeframe: pre-dose to 48 hours post-dose or to end of all AEs (if any), whichever is later.

Number of Participants with Treatment-Related Adverse Events

Timeframe: pre-dose to 48 hours post-dose or to end of all AEs (if any), whichever is later.

Cmax

Timeframe: pre-dose to 48 hours post-dose

Tmax

Timeframe: pre-dose to 48 hours post-dose

AUC(0-t)

Timeframe: pre-dose to 48 hours post-dose

AUC(0-inf)

Timeframe: pre-dose to 48 hours post-dose

Phase I PK and Safety Study of Ondansetron Inhalation Powder

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Phase I PK and Safety Study of Ondansetron Inhalation Powder

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria