Phase I PK and Safety Study of Ondansetron Inhalation Powder (NCT07498751) | Clinical Trial Compass
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 range18 Years – 55 Years
SexALL
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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).
✓. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination, vital signs, and/or ECG, as determined by an investigator.
Exclusion criteria
What they're measuring
1
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.
2
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.
3
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.
✕. Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration.
✕. History of significant hypersensitivity to ondansetron or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
✕. Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability.
✕. History of significant cardiovascular, metabolic, pulmonary/respiratory (asthma, chronic obstructive pulmonary disease, emphysema, or any other chronic pulmonary condition), hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease, or substance use disorder (excluding caffeine or nicotine).
✕. Presence of clinically significant ECG abnormalities at the Screening visit, as defined by medical judgment, including QTcF \> 440 msec.
✕. History of asthma or any allergy to common substances (animals, plants).
✕. Has a forced expiratory volume in the first second (FEV1) \< 80% predicted at Screening.