Study of Single and Multiple Doses of Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Healthy Subjects
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.
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Healthy
Intervention
i.v. fentanyl, 3 mL AeroLEF (500 µg/1 mL), 3 mL AeroLEF (500 µg/1 mL)
Location
University of Toronto
Toronto
Ontario
Canada
Status
Completed
Source
YM BioSciences
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00709254
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Fentanyl
A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078)
Droperidol
A butyrophenone with general properties similar to those of HALOPERIDOL. It is used in conjunction with an opioid analgesic such as FENTANYL to maintain the patient in a calm state of neuroleptanalgesia with indifference to surroundings but still able to cooperate with the surgeon. It is also used as a premedicant, as an antiemetic, and for the control of agitation in acute psychoses. (From Martindale, The Extra Pharmacopoeia, 29th ed, p593)
Alfentanil
A short-acting opioid anesthetic and analgesic derivative of FENTANYL. It produces an early peak analgesic effect and fast recovery of consciousness. Alfentanil is effective as an anesthetic during surgery, for supplementation of analgesia during surgical procedures, and as an analgesic for critically ill patients.
Clinical Trials
Study Evaluating Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Normal Healthy Subjects
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...
Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery
To evaluate the safety and efficacy of self-titration to effective analgesia with inhaled AeroLEF in patients with moderate/severe acute pain in the post-surgical setting.
The purpose of this study is to determine the effect of pain relief with AeroLEF in adult patients, following orthopedic surgery.
Study Evaluating Inhaled AeroLEF Delivered in 4 Aerosol Delivery Devices in Healthy Volunteers
This was an open-label, two-phase, crossover, safety, pharmacokinetic (PK), and pharmacodynamic (PD) study in normal, healthy, non-smoking, fasting male and female subjects. The first phas...
Staccato® Fentanyl Pharmacokinetics in Healthy Volunteers
The Phase I clinical trial in approximately 50 healthy volunteers will be conducted at a single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a single d...
PubMed Articles
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