Healthy
Conditions
Keywords
AeroLEF, fentanyl, pharmacokinetic, liposome, encapsulated
Brief summary
This was a pilot, phase I, two-period, fasting, bioavailability, safety,and pharmacokinetic study evaluating single dose of i.v. fentanyl (200 µg) and single doses of 2 mL or 3 mL inhaled AeroLEF (500 µg/mL) delivered by nebulization with the AeroEclipse BAN device administered in normal healthy non-smoking subjects.
Detailed description
In Period I, subjects received an intravenous dose of fentanyl (200 µg) administered over 1 minute (Treatment A). Subjects then crossed over to Period II. In Period II, subjects were randomly assigned to receive either 2 mL (1000 µg fentanyl; Treatment B) or 3mL (1500 µg fentanyl; Treatment C) of AeroLEF delivered by nebulization with the AeroEclipse BAN. Subjects were instructed to continue inhalation of AeroLEF for approximately 1 minute beyond the point of nebulizer sputter to ensure that all aerosolized medication was delivered. There was at least a 1 week washout period between study periods.
Interventions
DRUGi.v. fentanyl and AeroLEF
Period I: subjects received an intravenous dose of fentanyl (200 µg) (Treatment A). Period II: subjects were randomly assigned to receive either 2 mL (Treatment B) or 3mL (Treatment C) of AeroLEF delivered by nebulization with an AeroEclipse BAN.
Sponsors
YM BioSciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
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 | various time points |
Countries
Canada
Outcome results
None listed