MedTrace Logo

Study of Single and Multiple Doses of Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Healthy Subjects

NCT00709254 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2008-07-03

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

i.v. fentanyl

single dose, 200 ug

DRUG

3 mL AeroLEF (500 µg/1 mL)

A single dose of 3mL (500 µg/1 mL) of AeroLEF (Aerosolized Free and Liposome-Encapsulated Fentanyl)

DRUG

3 mL AeroLEF (500 µg/1 mL)

A multiple doses of 3mL (500 µg/1 mL)of AeroLEF (Aerosolized Free and Liposome-Encapsulated Fentanyl)every 12 hours for a total of five doses over a 3 days

Sponsors & Collaborators

  • YM BioSciences

    lead INDUSTRY

Principal Investigators

  • Diana Pilura, PhD · YM BioSciences

  • Paul Y Tam, MD, FACP · University of Toronto, Ontario, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2002-01-31
Completion
2002-01-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00709254 on ClinicalTrials.gov