A Study of Inhaled Fentanyl Aerosol in Chinese Patients With Malignant Tumors

NCT06953453 | Recruiting Phase 1

• 1 other identifier: ZK07
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a single-dose, open-label, 2-cycle crossover design, comparing the pharmacokinetic parameters and safety of Inhaled Fentanyl Aerosol and intravenous fentanyl injection.

Conditions

Cancer

Outcome Measures

Primary Outcomes (7)

• Cmax

  Peak Concentration

  Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration

• Tmax

  Time to Maximum Concentration

  Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration

• Ke

  Terminal Elimination Rate

  Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration

• T1/2

  Terminal elimination half-life

  Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration

• CL/F

  Apparent Clearance (CL/F)

  Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration

• AUC_last

  Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable Concentration

  Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration

• AUC_inf

  Area Under the Concentration-Time Curve from Time Zero to Infinity

  Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration

Secondary Outcomes (1)

• Pupil diameter

  Pupil measurements were taken before administration, and at 1, 2, 3, 5 , 10 , 30minutes , and 1, 2, 4, 8, 12 and 18hours after drug administration.

Study Arms (2)

Experimental:Inhaled fentanyl aerosol

EXPERIMENTAL

Subjects will be randomly assigned (1:1) to either drug sequence

Drug: Inhaled Fentanyl Aerosol

Active Comparator:Fentanyl Citrate Injection

ACTIVE COMPARATOR

Subjects will be randomly assigned (1:1) to either drug sequence

Drug: Fentanyl Citrate Injection

Interventions

Inhaled Fentanyl Aerosol DRUG

The subjects will be randomly assigned (1:1) to either dosing sequence: in the first cycle, receive an intravenous bolus (5 seconds) of 25μg Fentanyl injection, after at least a 2-week washout period, in the second cycle, receive a single dose of 25μg Fentanyl aerosol inhaler through the Staccato delivery system; or receive the same treatment in the reverse order.

Experimental:Inhaled fentanyl aerosol

Fentanyl Citrate Injection DRUG

The subjects will be randomly assigned (1:1) to either dosing sequence: in the first cycle, receive an intravenous bolus (5 seconds) of 25μg fentanyl injection, after at least a 2-week washout period, in the second cycle, receive a single dose of 25μg fentanyl aerosol inhaler through the Staccato delivery system; or receive the same treatment in the reverse order.

Active Comparator:Fentanyl Citrate Injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteer to participate, understand and sign the informed consent form before conducting the evaluation project;
• Male or female subjects, aged between 18 and 55, including 18 and 55 years old;
• Patients with malignant tumors diagnosed by histology or cytology;
• Body Mass Index (BMI) is \>21 kg/m2, but \<30 kg/m2;
• Have sufficient hematopoietic function and organ function within the last 14 days at random.
• The absolute neutrophil count is ≥1.5×109/L (has not received colony stimulating factor treatment within 14 days before the examination);
• Platelet count ≥80×109/L (without transfusion of platelets or other platelet-increasing drugs within 14 days before the examination);
• Hemoglobin ≥90g/L (without transfusion or treatment with other hemoglobin-increasing drugs within 7 days before the examination);
• Creatinine clearance rate (Ccr)≥30 ml/min, Cr≤2 times the upper limit of normal value;
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be ≤2.5×ULN, and for subjects with liver metastasis, it should be ≤5×ULN; total bilirubin should be ≤2 times the upper limit of normal value;
• Coagulation function INR≤1.5 ULN;
• In a non-oxygen-absorbing state, the oxygen saturation (from a pulse oximeter) is SaO2\>95%; pulmonary function shows FEV1/FVC\>70% and FEV1 as a percentage of the predicted value is\>80%;
• All patients must agree to take effective contraceptive measures during the study and within one month after stopping treatment. Female patients of childbearing age must have a negative blood pregnancy test before administration;
• The ECOG performance status score is 0\~1 points;

You may not qualify if:

• known or suspected allergy to opioids;
• used opioids within 14 days before the first administration, including but not limited to: codeine, dihydrocodeine, hydromorphone, oxycodone, methadone, morphine, fentanyl and pethidine (pethidine);
• plan to receive radiotherapy and / or systemic chemotherapy within 14 days before the first administration or during the study period (except for patients who receive immune checkpoint inhibitors or targeted drug maintenance therapy that is not a CYP3A4 inhibitor / inducer and whose condition is stable);
• within 14 days before the first administration, the patient had received any monoamine oxidase (MAO) inhibitors (such as phenelzine, isocarbazine, chlorogiline, toloxadone, moclobemide, selegiline, rasagiline, etc.); Or have used CYP3A4 inhibitors (such as indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, nefazodone, ketoconazole, telithromycin, arepitan, erythromycin, fluconazole, grapefruit, verapamil, diltiazem, cimetidine, etc.) or CYP3A4 inducers (such as phenobarbital, carbamazepine, efavirenz, glucocorticoids, modafinil, nevirapine, oxcarbazepine, phenytoin, pioglitazone, rifabutin, rifampicin);
• have participated in other clinical studies or received surgical treatment within 30 days before the screening period, or have surgery plans during the study period;
• subjects who smoked more than 10 cigarettes / day within 3 months before the screening period;
• subjects with a history of drug or alcohol dependence or abuse within 2 years before the screening period;
• subjects often eat food rich in xanthine (such as drinking more than 5 cups of coffee or food containing the same amount of xanthine every day);
• subjects with hypotension (systolic blood pressure \<90 mmHg, or diastolic blood pressure \<60 mmHg) or uncontrollable hypertension (refers to systolic blood pressure ≥ 160 mmHg, and / or diastolic blood pressure ≥ 100 mmHg after standard treatment);
• After antiviral treatment, HBV DNA\>500 IU/mL or\>2500 copies/mL; HCV-RNA positive; Positive for human immunodeficiency virus antibodies; Or positive for syphilis antibodies;
• subjects with positive alcohol test or urine test at any visit of the study;
• subjects with an expected survival time of \<1 year;
• subjects with clinically significant ECG abnormalities during screening;
• subjects with a history of lung diseases (asthma, bronchitis, bronchospasm, emphysema, interstitial lung disease, pulmonary fibrosis, etc., excluding lung malignancies);
• subjects with history of unstable angina pectoris, syncope, coronary artery disease, myocardial infarction, congestive heart failure (CHF), stroke, transient ischemic attack (TIA) or major neurological diseases;

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (2)

Henan Tumor Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Haiyan Hu, doctor

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiyan Hu, doctor

CONTACT

+86 18930174575; xurill@163.com

Study Design

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

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 1, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)