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

NCT07868861 | Recruiting Phase 1

• 1 other identifier: NP-013-OND
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (7)

• Ondansetron plasma concentrations over time

  Measurement in 15 time points

  Time zero (dosing) to 24 hours post dose

• Cmax

  Maximum Ondansetron level in plasma

  Time zero (doing) to 24 hours post dose

• Tmax

  Time to maximum Ondansetron level in plasma

  Time zero (doing) to 24 hours post dose

• Area Under the Curve (AUC)

  Total exposure to Ondansetron

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

• Kel

  The apparent first-order elimination rate constant

  From time zero (dosing) to 24 hours post dose

• Thalf

  The apparent elimination half-life

  From time zero (dosing) to 24 hours post dose

• AUCt/AUCinf

  The ratio of AUCt to AUCinf

  From time zero (dosing) to 24 hours post dose

Secondary Outcomes (8)

• Number of Participants With Adverse Events (AEs)

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

• Number of Participants With Serious Adverse Events (SAEs)

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

• Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

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

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

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

• Number of Participants With Clinically Significant Changes in body temperature

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

Study Arms (3)

NS003 Ondansetron HCl for nasal application, 5 mg

EXPERIMENTAL

Drug: NS003 Ondansetron HCl microspheres powder for nasal application

NS003 Ondansetron HCl for nasal application, 10 mg

EXPERIMENTAL

Drug: NS003 Ondansetron HCl microspheres powder for nasal application

Marketed Ondansetron Solution, for IV infusion (total dose 8 mg)

ACTIVE COMPARATOR

Drug: Ondansetron Solution for IV infusion 8mg

Interventions

NS003 Ondansetron HCl microspheres powder for nasal application DRUG

using nasal device (test)

NS003 Ondansetron HCl for nasal application, 10 mg; NS003 Ondansetron HCl for nasal application, 5 mg

Ondansetron Solution for IV infusion 8mg DRUG

Available marketed formulation (reference)

Marketed Ondansetron Solution, for IV infusion (total dose 8 mg)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Nasus Pharma: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, 9112001, Israel

RECRUITING

MeSH Terms

Conditions

Vomiting; Postoperative Nausea and Vomiting

Interventions

Infusions, Intravenous

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: October 9, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)