Chemotherapy-Induced Nausea and Vomiting (CINV)Phase 1NCT07817004
QLM2010 Comparative Pharmacokinetic Study With 2-Minute Intravenous Administration
A Phase 1 study testing apripitant and palonosetron injectable emulsion, palonosetron hydrochloride injection and apripitant injection (CINVANTI) in people with Chemotherapy-Induced Nausea and Vomiting (CINV), run by Qilu Pharmaceutical (Hainan) Co., Ltd..
Trial summary
This is a single-center, single-dose, randomized, open-label, crossover study. Forty-two healthy male and female participants will be enrolled. The study will consist of 3 periods in which participants will receive either the test product QLM2010 (18 mL: aprepitant 130 mg and palonosetron hydrochloride 0.25 mg… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-Induced Nausea and Vomiting (CINV)
- What is being tested?
- apripitant and palonosetron injectable emulsion, palonosetron hydrochloride injection and apripitant injection (CINVANTI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To voluntarily sign the informed consent form before the study, and fully understand the content, process and possible adverse reactions of the study;
- Ability to complete the study in accordance with the protocol requirements;
- 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.
- Male and female participants aged 18 to 55 years, inclusive;
- 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).
Who cannot join
- 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;
- 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.
- 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.
- 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;
- Hepatitis B surface antigen positive, hepatitis C antibody positive, or HIV antibody positive;
- 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;
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- Those who have difficulty in blood collection, or are unable to tolerate venipuncture, or have a history of fear of needles and hemophobia;
- History of drug abuse within the past 5 years, or drug use within 3 months prior to screening, or positive urine drug screen;
- 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;
- 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;
- 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;
- History of hospitalization or surgery within 3 months prior to the first dose, or surgery planned during the study;
- Participants who have participated in any clinical study and have taken any clinical study drug within 3 months prior to the first dose;
- 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;
- 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:
- Pimozide (contraindicated with aprepitant due to QT prolongation risk);
- Serotonergic medications (risk of serotonin syndrome with palonosetron);
- Warfarin (documented INR decrease with aprepitant); and
- QT-prolonging medications (increased cardiac risk with palonosetron).
- Those who used any prescription drugs, over-the-counter drugs, vaccines, herbal medicines, or health products within 14 days before the first dose;
- 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;
- 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;
- Those who have special requirements for diet and cannot comply with the diet provided and corresponding regulations;
- Participants may not be able to complete the study for other reasons or should not be included in the opinion of the investigator.
About this study
This is a single-center, single-dose, randomized, open-label, crossover study. Forty-two healthy male and female participants will be enrolled. The study will consist of 3 periods in which participants will receive either the test product QLM2010 (18 mL: aprepitant 130 mg and palonosetron hydrochloride 0.25 mg, manufactured by Qilu Pharmaceutical [Hainan] Co., Ltd.) or the Reference Product 1 (aprepitant injection CINVANTI®, 18 mL: 130 mg, manufactured by Alcami Carolinas Corp.) or the Reference Product 2 (palonosetron hydrochloride injection, 5 mL: 0.25 mg, manufactured by Dr Reddys Laboratories Ltd.) by intravenous injection under fasting conditions in each period. The washout period between 2 consecutive doses will be at least 14 days. Plasma concentrations of aprepitant and palonosetron at different sampling times will be determined by HPLC-MS/MS. Pharmacokinetic parameters will be calculated using noncompartmental analysis (NCA) and subjected to statistical analysis.
- Being tested
- apripitant and palonosetron injectable emulsion, palonosetron hydrochloride injection, apripitant injection (CINVANTI)
- Keywords
- CINV
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apripitant and palonosetron injectable emulsionDrug
This is the test product involved in this study.
palonosetron hydrochloride injectionDrug
This is the second reference drug involved in this study, named as R2.
apripitant injection (CINVANTI)Drug
This is the first reference product, named as R1
| Study group | Role | What they receive |
|---|---|---|
| apripitant and palonosetron injectable emulsion | Experimental | Not described Receives: Drug: apripitant and palonosetron injectable emulsion |
| apripitant injection (CINVANTI) | Active comparator | Not described Receives: Drug: apripitant injection (CINVANTI) |
| palonosetron hydrochloride injection | Active comparator | Not described Receives: Drug: palonosetron hydrochloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC)
The AUC data will be presented by analyzing the concentration data of all completed participants using the SAS V9.4 software
Measured: up to 10 weeks
Peak Plasma Concentration (Cmax)
The peak plasma concentration (Cmax) will be presented by analyzing the concentration data of all completed participants using SAS V9.4 software
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817004
- Sponsor's protocol ID
- QLM2010-103
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QLM2010 Comparative Pharmacokinetic Study With 2-Minute Intravenous Administration
- ClinicalTrials.gov ID
- NCT07817004
- Acronym / sponsor ID
- QLM2010-103
- Keywords
- CINV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, single-dose, randomized, open-label, crossover study. Forty-two healthy male and female participants will be enrolled. The study will consist of 3 periods in which participants will receive either the test product QLM2010 (18 mL: aprepitant 130 mg and palonosetron hydrochloride 0.25 mg, manufactured by Qilu Pharmaceutical [Hainan] Co., Ltd.) or the Reference Product 1 (aprepitant injection CINVANTI®, 18 mL: 130 mg, manufactured by Alcami Carolinas Corp.) or the Reference Product 2 (palonosetron hydrochloride injection, 5 mL: 0.25 mg, manufactured by Dr Reddys Laboratories Ltd.) by intravenous injection under fasting conditions in each period. The washout period between 2 consecutive doses will be at least 14 days. Plasma concentrations of aprepitant and palonosetron at different sampling times will be determined by HPLC-MS/MS. Pharmacokinetic parameters will be calculated using noncompartmental analysis (NCA) and subjected to statistical analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| apripitant and palonosetron injectable emulsion | Experimental | Drug: apripitant and palonosetron injectable emulsion |
| apripitant injection (CINVANTI) | Active comparator | Drug: apripitant injection (CINVANTI) |
| palonosetron hydrochloride injection | Active comparator | Drug: palonosetron hydrochloride injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- To voluntarily sign the informed consent form before the study, and fully understand the content, process and possible adverse reactions of the study;
- Ability to complete the study in accordance with the protocol requirements;
- 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.
- Male and female participants aged 18 to 55 years, inclusive;
- 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).
Key exclusion criteria (24 listed)
- 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;
- 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.
- 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.
- 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;
- Hepatitis B surface antigen positive, hepatitis C antibody positive, or HIV antibody positive;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apripitant and palonosetron injectable emulsionThis is the test product involved in this study. | Drug | apripitant and palonosetron injectable emulsion |
| palonosetron hydrochloride injectionThis is the second reference drug involved in this study, named as R2. | Drug | palonosetron hydrochloride injection |
| apripitant injection (CINVANTI)This is the first reference product, named as R1 | Drug | apripitant injection (CINVANTI) |
Primary outcome
Area Under the Curve (AUC)
Time frame: up to 10 weeks
The AUC data will be presented by analyzing the concentration data of all completed participants using the SAS V9.4 software
Peak Plasma Concentration (Cmax)
Time frame: up to 10 weeks
The peak plasma concentration (Cmax) will be presented by analyzing the concentration data of all completed participants using SAS V9.4 software
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing apripitant and palonosetron injectable emulsion, palonosetron hydrochloride injection and apripitant injection (CINVANTI) in people with Chemotherapy-Induced Nausea and Vomiting (CINV), run by Qilu Pharmaceutical (Hainan) Co., Ltd..
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 5 inclusion and 24 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Area Under the Curve (AUC) (time frame: up to 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.