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Chemotherapy-Induced Nausea and Vomiting (CINV)Phase 1NCT07868861

A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults

A Phase 1 study testing NS003 Ondansetron HCl microspheres powder for nasal application and Ondansetron Solution for IV infusion 8mg in people with Chemotherapy-Induced Nausea and Vomiting (CINV) and Radiotherapy-induced Nausea and Vomiting (RINV), run by Nasus Pharma at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
NS003 Ondansetron HCl microspheres powder for nasal application and Ondansetron Solution for IV infusion 8mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteIsrael
Study dates
15 Sep 2026to Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Non-smoking, male and female subjects from 18 to 65 years of age.
  • BMI 18-30 kg/m2.
  • Females may be of childbearing or non-childbearing potential:
  • Childbearing potential:
  • o Physically capable of becoming pregnant, must be willing to use acceptable effective methods of contraception
  • Non-childbearing potential:
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  • Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation); and/or
  • Postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause)
  • Able to tolerate venipuncture.
  • Be informed of the nature of the study and give written consent prior to any study procedure.
  • Willing and being able to remain in the clinic for the entire duration of the confinement period.
  • Have good intravenous access on both arms and hands.
  • TNSS Score =0

Who cannot join

  • Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, hepatic , psychiatric, or cardiovascular disease (including bradyarrhythmias) or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
  • Known history or presence of hypersensitivity reaction to ondansetron (Zofran), any excipients of ondansetron, or any other drug substances with similar activity.
  • (commercial names in Israel: ODNATRON injection; ONDANSETRON - FRESENIUS injection; ONDANSETRON KALCEKS injection; ONDANSETRON INOVAMED oral tabs, ONDANSETRON BAXTER injection; Zofran oral tabs).
  • Known history or presence of any food allergy.
  • Presence of nostril or septum piercing which may interfere with nasal administration.
  • Presence of abnormal nasal anatomy (e.g., polyps, unilateral or bilateral abnormalities of the nares, nasal turbinates, or septum including deviated septum).
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  • History of nasal surgery.
  • Presence of a medical condition requiring medication (prescription and/or over-the-counter) with systemic absorption other than oral contraceptives or hormone replacement therapy.
  • History of drug or alcohol addiction requiring treatment or positive drug/alcohol test at screening and check-in.
  • Any acute illness (e.g. cold, acute infection) which is considered significant by the Investigator and that has not resolved within 7 days before the first drug administration.
  • Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
  • Positive test result for urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and tricyclic antidepressants) or urine cotinine.
  • Difficulty fasting or consuming standard meals.
  • Inability to communicate well with the Investigators and staff.
  • Non-cooperative or unwilling to sign consent form or unwilling to attend scheduled clinic visits and/or comply with the study protocol.
  • Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
  • Females who:
  • Are pregnant (hCG result consistent with pregnancy); or
  • Are lactating.
  • Donation or loss of whole blood (including clinical trials):
  • ≥50 mL and <500 mL within 30 days prior to drug administration;
  • ≥500 mL within 56 days prior to drug administration.
  • Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
  • On a special diet within 20 days prior to drug administration (e.g., liquid, protein, raw food diet).
  • Have had a tattoo or body piercing within 30 days prior to drug administration.
  • Have clinically significant findings in vital signs measurements at screening.
  • Have clinically significant findings in a 12-lead ECG, specifically abnormal QT/QTc interval
  • Subjects with congenital long QT syndrome
  • Have clinically significant abnormal laboratory values and hemoglobin <135 g/L for males or <120 g/L for females at screening.
  • Subjects with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia)
  • Have significant diseases at screening.
  • Have clinically significant findings from a physical examination.
  • Use of the following drugs within 30 days prior to drug administration:
  • Apomorphine (contraindication)
  • Drugs having effect on cytochrome P450 (CYP450);
  • Serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue)
  • Medicinal products that lead to QT prolongation (e.g. Amiodarone, Citalopram, Clarithromycin, Diphenhydramine, Erythromycin, Fluconazole - not exhaustive)
  • Use of the following drugs within 7 days prior to drug administration:
  • Nasal decongestants including nasal antihistamines;
  • Nonsteroidal anti-inflammatory drugs (NSAIDs); or
  • Oral or topical antihistamines.
  • Use of any medication within 1 year prior to drug administration with Thalf longer than 1 week

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Israel1 site, 1 recruiting

  • Hadassah Medical Center

    Jerusalem, 9112001

    Yoseph Caraco, Prof., +972-2-6779374, caraco.yoseph@mail.huji.ac.il

    Recruiting

Other trials in Israel

About this study

A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults

Being tested
NS003 Ondansetron HCl microspheres powder for nasal application, Ondansetron Solution for IV infusion 8mg
Medical subject headings
Vomiting, Postoperative Nausea and Vomiting

What participants receive

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

  • NS003 Ondansetron HCl microspheres powder for nasal applicationDrug

    using nasal device (test)

  • Ondansetron Solution for IV infusion 8mgDrug

    Available marketed formulation (reference)

Study groups in NCT07868861
Study groupRoleWhat they receive
NS003 Ondansetron HCl for nasal application, 5 mgExperimentalNot described
Receives: Drug: NS003 Ondansetron HCl microspheres powder for nasal application
NS003 Ondansetron HCl for nasal application, 10 mgExperimentalNot described
Receives: Drug: NS003 Ondansetron HCl microspheres powder for nasal application
Marketed Ondansetron Solution, for IV infusion (total dose 8 mg)Active comparatorNot described
Receives: Drug: Ondansetron Solution for IV infusion 8mg

What is being measured

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

  1. Ondansetron plasma concentrations over time

    Measurement in 15 time points

    Measured: Time zero (dosing) to 24 hours post dose

  2. Cmax

    Maximum Ondansetron level in plasma

    Measured: Time zero (doing) to 24 hours post dose

  3. Tmax

    Time to maximum Ondansetron level in plasma

    Measured: Time zero (doing) to 24 hours post dose

  4. Area Under the Curve (AUC)

    Total exposure to Ondansetron

    Measured: Time zero to 24 hours post dose (several trancations over time)

  5. Kel

    The apparent first-order elimination rate constant

    Measured: From time zero (dosing) to 24 hours post dose

  6. Thalf

    The apparent elimination half-life

    Measured: From time zero (dosing) to 24 hours post dose

  7. AUCt/AUCinf

    The ratio of AUCt to AUCinf

    Measured: From time zero (dosing) to 24 hours post dose

Secondary outcomes (8)

  1. Number of Participants With Adverse Events (AEs)

    Measured: Dosing to follow-up visit (1 week after last dose)

  2. Number of Participants With Serious Adverse Events (SAEs)

    Measured: Dosing to follow-up visit (1 week after last dose)

  3. Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

    Measured: Dosing to follow-up visit (1 week after last dose)

  4. Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)

    Measured: Screening to follow-up visit (1 week after last dose)

  5. Number of Participants With Clinically Significant Changes in body temperature

    Measured: Screening to follow-up visit (1 week after last dose)

  6. Number of Participants With Clinically Significant Changes in Blood Pressure

    Measured: Screening to follow up visit (1 week after last dose)

  7. Number of Participants With Clinically Significant Changes in Heart Rate

    Measured: Screening to follow up visit (1 week after last dose)

  8. Number of Participants With Clinically Significant Changes in Breath Rate

    Measured: Screening to Follow-up visit (1 week after last dose)

Timeline

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

  1. First posted9 Oct 2026
  2. Study start15 Sep 2026
  3. Primary completionJan 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

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
Other
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07868861
Sponsor's protocol ID
NP-013-OND
Status last verified
Oct 2026
First submitted
20 Sep 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NS003 Ondansetron HCl microspheres powder for nasal application and Ondansetron Solution for IV infusion 8mg in people with Chemotherapy-Induced Nausea and Vomiting (CINV) and Radiotherapy-induced Nausea and Vomiting (RINV), run by Nasus Pharma at 1 site in Israel.

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 13 inclusion and 42 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: looking for participants now, as of the sponsor's last update on 9 Oct 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 Israel. 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. 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ondansetron plasma concentrations over time (time frame: Time zero (dosing) to 24 hours post dose). The study lists 7 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 NCT07868861.

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 9 Oct 2026.

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