Healthy
Conditions
Keywords
AeroLEF, fentanyl, pharmacokinetics, liposome, encapsulated
Brief summary
This study was designed to assess single-dose and multiple-dose PK and safety parameters utilizing a dosage of 3 mL (500 µg/mL)AeroLEF delivered via nebulization with the AeroEclipse BAN device. The study was conducted in opioid naïve subjects who were not blocked with naloxone or other opioid receptor antagonists.
Detailed description
Period I: Subjects received an i.v.dose of fentanyl (200 µg) (Treatment A). Period II: Subjects were randomly assigned to receive either a single-dose (Treatment B) or multi-dose (Treatment C) of AeroLEF. In the multi-dose Treatment C group, subjects received a dose of 3 mL AeroLEF every 12 hours for a total of five doses over a 3 days with a 4 week washout period before crossing over to Period III. Period III: Subjects from Period II participated in the crossover study and receive either a multi-dose (Treatment C, 5 doses at 12 hour intervals) or a single dose (Treatment B). Subjects in Treatment B or Treatment C were instructed to continue inhalation of AeroLEF for approximately one (1) minute beyond the point of nebulizer sputter to ensure that all aerosolized medication was delivered.
Interventions
DRUGi.v. fentanyl
single dose, 200 ug
DRUG3 mL AeroLEF (500 µg/1 mL)
A single dose of 3mL (500 µg/1 mL) of AeroLEF (Aerosolized Free and Liposome-Encapsulated Fentanyl)
Sponsors
YM BioSciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Non-smoking male or female with a minimum age of at least 18 years * Body weight with aBMI range of 18.5 - 27, with a minimum weight of at least 60 kg. * Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed, written, Informed Consent Form. * Normal findings in the physical examination, vital signs (blood pressure between 100-140 - 60-90 mmHg, heart rate between 55-99 beats/min, respiration rate between 12-20 minute) and a 12 lead ECG. * Negative for drug abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and HIV. * If a female of child-bearing potential, the patient must have a negative urine pregnancy test at screening and baseline. * No clinical laboratory values outside of the Principal Investigator's acceptable range, unless the Principal Investigator decided that the subject's values are not clinically significant. * Female subjects: (a) if pre-menopausal, have regular menstrual cycles (28-32 days), and (b) are not pregnant prior to study start and avoids pregnancy during the study and 1 month post drug administration, or (c) were surgically sterile for at least 6 months prior to enrollment, or (d) are post-menopausal for at least 1 year prior to enrollment.
Exclusion criteria
* Known history of hypersensitivity to fentanyl. * Presence or history of cardiac, pulmonary, gastrointestinal, endocrine, neuromuscular, neurologic, hematological, liver or kidney disease, or any condition known to interfere with absorption, distribution , metabolism, or excretion of drugs. * History of drug abuse or narcotic dependency. * Use of prescription medication within 30 days preceding entry int the study, including any enzyme inducing/inhibitory drugs (excluding contraceptives). * Participating in a clinical trial with an investigational drug within 30 days preceding this trial. * Blood donation within 45 days preceding this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events | continuously |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics and bioavailability | various time points |
Countries
Canada
Outcome results
None listed