Can one fast shot replace two drugs for chemo nausea?

NCT ID NCT07817004

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing a new injectable emulsion that combines aprepitant and palonosetron, two drugs used to prevent nausea and vomiting after chemotherapy. The study gives the combination or each drug separately to 42 healthy volunteers in three periods, with at least 14 days between doses. By measuring drug levels in the blood, the team aims to see whether the body processes the combination the same way as the individual reference products.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a combined injectable emulsion of aprepitant and palonosetron
What this could lead to
If the combined injection behaves like the separate reference drugs, it could offer a faster, single-shot option for preventing chemotherapy-related nausea and vomiting.
What could go wrong
This is a small Phase 1 study in healthy volunteers, so it cannot show whether the combination actually works better in patients. The body may process the drugs differently than expected, and the study may not confirm that the combination is equivalent to the standard separate injections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. To voluntarily sign the informed consent form before the study, and fully understand the content, process and possible adverse reactions of the study; 2. Ability to complete the study in accordance with the protocol requirements; 3. Participants (including male participants) must use effective contraceptive methods for 14 days prior to the first dose and voluntarily agree to maintain effective contraception from signing the informed consent until 3 months after the last dose, with no plans for pregnancy, sperm donation, or oocyte donation during this period. Specific contraceptive requirements are detailed in Appendix 1. 4. Male and female participants aged 18 to 55 years, inclusive; 5. Body weight ≥45.0 kg for female participants and ≥50.0 kg for male participants with a body mass index (BMI) between 18.0 and 30.0 kg/m2 (both inclusive). Exclusion Criteria: 1. History or presence of any clinically significant disorder of the circulatory, endocrine, neurological, digestive, respiratory, genitourinary, hematological, immunological, psychiatric, and metabolic disorders or any other disease that could interfere with the results of the study; 2. Abnormal screening or check-in laboratory values including inadequate renal and hepatic function as assessed by the investigator (eGFR \<90 mL/min/1.73 m² calculated using CKD-EPI 2021 at screening, and total bilirubin, ALP, GGT, AST, and ALT outside normal range). A single repeat measurement is permitted for abnormal laboratory values for determining eligibility, at the discretion of the investigator. 3. Clinically significant abnormal physical examination, vital signs (systolic blood pressure \<90 mmHg or \>140 mmHg, diastolic blood pressure \<50 mmHg or \>90 mmHg; heart rate \<50 bpm or \>100 bpm; temperature 35.6°C to 37.7°C), ECG (QTcF \>450ms for males and \>470ms for females), or laboratory findings, as judged by the investigator. A repeat vital sign or ECG measurement, at the investigator's discretion, is acceptable for determining eligibility. Vital sign measurements may be repeated at Screening and/or Check-in, as required. 4. Participants with a history of specific allergies (such as urticaria, allergic asthma, etc.), or 2 or more types of allergens (such as drugs, foods such as milk and pollen), or allergies to any of soybeans, alcohol, eggs, or known allergies to components or analogues of this drug; 5. Hepatitis B surface antigen positive, hepatitis C antibody positive, or HIV antibody positive; 6. Women who are pregnant or breastfeeding, or who have a positive pregnancy test, or who are using long-acting contraceptives or implants other than those listed in Appendix 1; 7. Those who have difficulty in blood collection, or are unable to tolerate venipuncture, or have a history of fear of needles and hemophobia; 8. History of drug abuse within the past 5 years, or drug use within 3 months prior to screening, or positive urine drug screen; 9. Participants with past or current history or evidence of drug or alcohol abuse, or regular alcohol intake \>14 units per week for male participants and \>7 units per week for female participants (1 unit of alcohol = 150 mL of wine, 360 mL of beer, or 45 mL of alcohol 40%). Positive urine alcohol/ethanol test or urine drug screen at Screening or Day -1; 10. Those who smoked more than 5 cigarettes per day on average within 3 months before screening or those who refuse to quit using tobacco products during the confinement period; 11. Blood donation or significant blood loss (≥200 mL, excluding menstrual blood loss in females), receive blood transfusion, or blood product use within 3 months prior to the first dose; 12. History of hospitalization or surgery within 3 months prior to the first dose, or surgery planned during the study; 13. Participants who have participated in any clinical study and have taken any clinical study drug within 3 months prior to the first dose; 14. Use of any strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir, diltiazem, etc.) or strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, etc.) within 30 days prior to the first dose; 15. Currently used or recently discontinued the use of any contraindications that may pose safety risks on aprepitant and/or palonosetron within 3 months before screening including: 1. Pimozide (contraindicated with aprepitant due to QT prolongation risk); 2. Serotonergic medications (risk of serotonin syndrome with palonosetron); 3. Warfarin (documented INR decrease with aprepitant); and 4. QT-prolonging medications (increased cardiac risk with palonosetron). 16. Those who used any prescription drugs, over-the-counter drugs, vaccines, herbal medicines, or health products within 14 days before the first dose; 17. Those who have consumed grapefruits and products containing grapefruit ingredients or have strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 48 hours before receiving the study drug; 18. Those who have consumed any xanthine-rich foods (such as coffee, tea, chocolate, cocoa, cola, milk tea, etc.) within 48 hours before receiving the study drug; 19. Those who have special requirements for diet and cannot comply with the diet provided and corresponding regulations; 20. Participants may not be able to complete the study for other reasons or should not be included in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

Vomiting

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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