Study Evaluating Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Normal Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: i.v. fentanyl and AeroLEF

• Registration Number: NCT00708318
• Lead Sponsor: YM BioSciences

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.

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2001-11
• Study Completion: 2002-06
• Status Verified: 2008-07
• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-01
• Last Update Submitted: 2008-07-01
• Study First Posted: 2008-07-02
• Last Update Posted: 2008-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A, B, C	i.v. fentanyl and AeroLEF	-

Primary Outcome Measures

Name	Time	Method
Adverse Events	continuously

Secondary Outcome Measures

Name	Time	Method
pharmacokinetics	various time points

Trial Locations

Locations (1)

University of Toronto; 🇨🇦 Toronto, Ontario, Canada