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Postoperative Nausea and VomitingPhase 1NCT07498751

Phase I PK and Safety Study of Ondansetron Inhalation Powder

A Phase 1 study testing LPI-1503, IV Ondansetron and Oral Ondansetron in people with Postoperative Nausea and Vomiting, run by Luxena Pharmaceuticals, Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Nausea and Vomiting
What is being tested?
LPI-1503, IV Ondansetron and Oral Ondansetron
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteCanada
Study dates
13 Mar 2025to 23 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.
  • Can demonstrate ability to properly use the RS01® inhaler.

Who cannot join

  • Female who is lactating.
  • 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.
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  • 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.
  • Immunization with a Coronavirus Disease 2019 (COVID-19) vaccine in the 14 days prior to the first study drug administration.
  • Scheduled immunization with a COVID-19 vaccine during the study that, in the opinion of an investigator, could potentially interfere with subject participation, subject safety, study results, or any other reason.
  • Any clinically significant illness (including COVID-19 infections) in the 28 days prior to the first study drug administration.
  • Use of any prescription drugs in the 28 days prior to the first study drug administration that in the opinion of an investigator would put into question the status of the subject as healthy.
  • Use of St. John's wort in the 28 days prior to the first study drug administration.
  • Any history of latent or active tuberculosis.
  • Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first drug administration.
  • Positive Screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus antibody tests.
  • Any other clinically significant abnormalities in laboratory test results at Screening or prior to the first drug administration that would, in the opinion of an investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data.
  • Inclusion in a previous cohort for this clinical study.
  • Intake of ondansetron in the 28 days prior to the first study drug administration.
  • Intake of an investigational product (IP) in the 28 days prior to the first study drug administration.
  • Donation of plasma in the 7 days prior to the first study drug administration.
  • Donation of 50 mL or more of blood in the 28 days prior to the first study drug administration.
  • Donation of 500 mL or more of blood in the 56 days prior to the first study drug administration.
  • Use of nicotine or any products containing nicotine in the 180 days prior to the first study drug administration.
  • Use of any enzyme-modifying drugs, including any CYP3A4, CYP2D6, or CYP1A2 inducers or inhibitors, in the 28 days prior to the first study drug administration.
  • Estimated glomerular filtration rate < 60 mL/minute/1.73 m2 (as estimated by the Modification of Diet in Renal Disease formula) at Screening or prior to the first study treatment administration.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Altasciences Clinical Research Unit

    Mount Royal, Quebec, H3P 3P1

Other trials in Canada

About this study

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

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?

Read more

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.

Being tested
LPI-1503, Matching Placebo of LPI-1503, IV Ondansetron, Oral Ondansetron
Medical subject headings
Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LPI-1503Drug

    Also called Ondansetron Inhalation Powder

    Micronized ondansetron blended with excipients, to be administrated by inhalation, by using a single-capsule inhaler RS01(R).

  • Matching Placebo of LPI-1503Drug

    Also called Matching Placebo of Ondansetron Inhalation Powder

    Powder that contains only excipient (no API), to be administrated by inhalation, by using a single-capsule inhaler RS01(R).

  • IV OndansetronDrug

    Also called Ondansetron Injection Solution

    4mg Ondansetron to be administrated by IV as an active comparator in Period 2.

  • Oral OndansetronDrug

    Also called Ondansetron Tablet

    8mg ondansetron to be orally administrated as an active comparator in Period 2.

Study groups in NCT07498751
Study groupRoleWhat they receive
4mg LPI-1503 in Period 1, 8mg Oral Ondansetron in Period 2ExperimentalLPI-1503 = Ondansetron Inhalation Powder, 4mg is nominal dose. 8mg oral Ondansetron is an active comparator. Washout between Periods >= 7 days.
Receives: Drug: LPI-1503; Drug: Oral Ondansetron
4mg LPI-1503 in Period 1, 4mg IV Ondansetron in Period 2ExperimentalLPI-1503 = Ondansetron Inhalation Powder, 4mg is nominal dose. 4mg IV Ondansetron is an active comparator. Washout between Periods >= 7 days.
Receives: Drug: LPI-1503; Drug: IV Ondansetron
8mg LPI-1503 in Period 1, 8mg Oral Ondansetron in Period 2ExperimentalLPI-1503 = Ondansetron Inhalation Powder, 8mg is nominal dose. 8mg oral Ondansetron is an active comparator. Washout between Periods >= 7 days.
Receives: Drug: LPI-1503; Drug: Oral Ondansetron
8mg LPI-1503 in Period 1, 4mg IV Ondansetron in Period 2ExperimentalLPI-1503 = Ondansetron Inhalation Powder, 8mg is nominal dose. 4mg IV Ondansetron is an active comparator. Washout between Periods >= 7 days.
Receives: Drug: LPI-1503; Drug: IV Ondansetron
12mg LPI-1503 in Period 1, 8mg Oral Ondansetron in Period 2ExperimentalLPI-1503 = Ondansetron Inhalation Powder, 12mg is nominal dose. 8mg oral Ondansetron is an active comparator. Washout between Periods >=7 days.
Receives: Drug: LPI-1503; Drug: Oral Ondansetron
12mg LPI-1503 in Period 1, 4mg IV Ondansetron in Period 2ExperimentalLPI-1503 = Ondansetron Inhalation Powder, 12mg is nominal dose. 4mg IV Ondansetron is an active comparator. Washout between Periods >= 7 days.
Receives: Drug: LPI-1503; Drug: IV Ondansetron
Matching Placebo in Period 1Placebo comparatorMatching Placebo of LPI-1503. There is no Period 2 in this Arm.
Receives: Drug: Matching Placebo of LPI-1503

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Treatment-Emergent Adverse Events

    An Adverse Event (AE) is defined as any untoward medical occurrence in a subject administered a study drug (including the placebo or the positive comparators), which dose not necessarily have a causal relationship with the treatment.

    For example (but not limited to), any Clinical Significant Changes/Findings in Clinically Laboratory, Spirometry, Pulse Oximetry, Vitals Signs, Physical Examinations, or Electrocardiogram (ECG) will be reproted as AEs.

    An Treatment-Emergent Adverse Events (TEAE) is defined as any AE occurred at the time of, or after, administration of the study drug.

    Number of Participants with TEAE will also summarized by Severity, for which all AEs will be graded per the current FDA Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.

    Measured: 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.

    An Serious Adverse Event (SAE) is any AE that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity (defined as a substantial disruption of a person's ability to conduct normal life functions), is a congenital anomaly or birth defect, or is an important medical event that may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above (according to medical judgment of aninvestigator).

    Measured: 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

    Reasonable Possibility of Treatment-Relatedness:

    A temporal relationship exists between the AE onset and administration of the IP that cannot be readily explained by the subject's clinical state or concomitant therapies. Furthermore, the AE appears with some degree of certainty to be related, based on the known therapeutic and pharmacologic actions or AE profile of the IP.

    No Reasonable Possibility of Treatment-Relatedness:

    Evidence exists that the AE has an etiology other than the IP. For SAEs, an alternative causality must be provided (eg, preexisting condition, underlying disease, intercurrent illness, or concomitant medication).

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

  4. Cmax

    Cmax (ng/mL): maximum observed concentration of ondansetron in plasma

    Measured: pre-dose to 48 hours post-dose

  5. Tmax

    Tmax (hour): time of maximum observed concentration of ondansetron in plasma

    Measured: pre-dose to 48 hours post-dose

  6. AUC(0-t)

    AUC(0-t) (h*mg/mL): area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration

    Measured: pre-dose to 48 hours post-dose

  7. AUC(0-inf)

    AUC(0-inf) (h*ng/mL): area under the concentration time curve extrapolated to infinity, calculated as AUC(0-t) + C(last)/λz, where C(last) is the last quantifiable concentration

    Measured: pre-dose to 48 hours post-dose

  8. t(1/2)

    t(1/2) (hour): terminal elimination half-life, calculated as ln(2)/λz

    Measured: pre-dose to 48 hours post-dose

  9. CL/F

    CL/F (mL/h) (inhalation and oral tablet ondansetron only): apparent clearance of drug, calculated as Dose/AUC(0-inf)

    Measured: pre-dose to 48 hours post-dose

  10. Vd/F

    Vd/F (mL) (inhalation and oral tablet ondansetron only): apparent volume of distribution during the terminal phase, calculated as Dose/(λz × AUC(0-inf))

    Measured: pre-dose to 48 hours post-dose

  11. CL

    CL (mL/h) (IV ondansetron only): total plasma clearance of drug, calculated as Dose/AUC(0-inf)

    Measured: pre-dose to 48 hours post-dose

  12. Vd

    Vd (mL) (IV ondansetron only): volume of distribution during the terminal phase, calculated as Dose/(λz × AUC(0-inf))

    Measured: pre-dose to 48 hours post-dose

  13. Absolute Bioavailability (F)

    Absolute Bioavailability (F) is calculated as:

    AUC(0-T)/D of inhalation / AUC(0-T)/D of IV

    Measured: pre-dose to 48 hours post-dose

  14. Relative Bioavailability (F rel)

    Relative Bioavailability (F rel) is calculated as:

    AUC(0-T)/D of inhalation / AUC(0-T)/D of oral tablet

    Measured: pre-dose to 48 hours post-dose

Secondary outcomes (3)

  1. Cmax/D

    Cmax/D (ng/mL/mg): maximum observed concentration of ondansetron in plasma normalized to dose

    Measured: pre-dose to 48 hours post-dose

  2. AUC(0-t)/D

    AUC(0-t)/D (h*ng/mL/mg): area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration, normalized to dose

    Measured: pre-dose to 48 hours post-dose

  3. AUC(0-inf)/D

    AUC(0-inf)/D (h*ng/mL/mg): area under the concentration time curve extrapolated to infinity, calculated as AUC(0-t) + C(last) / λz, where Clast is the last quantifiable concentration, normalized to dose

    Measured: pre-dose to 48 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start13 Mar 2025
  3. Primary completion23 Aug 2025
  4. Study completion23 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07498751
Sponsor's protocol ID
LPI-1503-901
Other IDs
LOO-P3-703
Status last verified
Mar 2026
First submitted
11 Mar 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LPI-1503, IV Ondansetron and Oral Ondansetron in people with Postoperative Nausea and Vomiting, run by Luxena Pharmaceuticals, Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment-Emergent Adverse Events (time frame: pre-dose to 48 hours post-dose or to end of all AEs (if any), whichever is later.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07498751.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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