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

ConditionCancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorLee's Pharmaceutical Limited

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Experimental:Inhaled fentanyl aerosolExperimental treatment 1 intervention
Group B: Active Comparator:Fentanyl Citrate InjectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cmax

Peak Concentration

Time frame
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
2

Tmax

Time to Maximum Concentration

Time frame
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
3

Ke

Terminal Elimination Rate

Time frame
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
4

T1/2

Terminal elimination half-life

Time frame
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

Measure the pupil diameter using a pupillometer.

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.