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.
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
- Conditions the study is for
- Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV), Postoperative Nausea and Vomiting
- 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
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
- Recruiting
Hadassah Medical Center
Jerusalem, 9112001
Yoseph Caraco, Prof., +972-2-6779374, caraco.yoseph@mail.huji.ac.il
About this study
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
- Conditions
- Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV), Postoperative Nausea and Vomiting
- 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 group | Role | What they receive |
|---|---|---|
| NS003 Ondansetron HCl for nasal application, 5 mg | Experimental | Not described Receives: Drug: NS003 Ondansetron HCl microspheres powder for nasal application |
| NS003 Ondansetron HCl for nasal application, 10 mg | Experimental | Not described Receives: Drug: NS003 Ondansetron HCl microspheres powder for nasal application |
| Marketed Ondansetron Solution, for IV infusion (total dose 8 mg) | Active comparator | Not 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.
Ondansetron plasma concentrations over time
Measurement in 15 time points
Measured: Time zero (dosing) to 24 hours post dose
Cmax
Maximum Ondansetron level in plasma
Measured: Time zero (doing) to 24 hours post dose
Tmax
Time to maximum Ondansetron level in plasma
Measured: Time zero (doing) to 24 hours post dose
Area Under the Curve (AUC)
Total exposure to Ondansetron
Measured: Time zero to 24 hours post dose (several trancations over time)
Kel
The apparent first-order elimination rate constant
Measured: From time zero (dosing) to 24 hours post dose
Thalf
The apparent elimination half-life
Measured: From time zero (dosing) to 24 hours post dose
AUCt/AUCinf
The ratio of AUCt to AUCinf
Measured: From time zero (dosing) to 24 hours post dose
Secondary outcomes (8)
Number of Participants With Adverse Events (AEs)
Measured: Dosing to follow-up visit (1 week after last dose)
Number of Participants With Serious Adverse Events (SAEs)
Measured: Dosing to follow-up visit (1 week after last dose)
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Measured: Dosing to follow-up visit (1 week after last dose)
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
Measured: Screening to follow-up visit (1 week after last dose)
Number of Participants With Clinically Significant Changes in body temperature
Measured: Screening to follow-up visit (1 week after last dose)
Number of Participants With Clinically Significant Changes in Blood Pressure
Measured: Screening to follow up visit (1 week after last dose)
Number of Participants With Clinically Significant Changes in Heart Rate
Measured: Screening to follow up visit (1 week after last dose)
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.
- First posted9 Oct 2026
- Study start15 Sep 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Nausea and Vomiting (CINV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Nasus Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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