Completed PHASE1 INTERVENTIONAL 1-arm NCT00708318

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

A Pilot, Phase I, 2-Period, Fasting, Bioavailability, Safety and PK Study Evaluating A Single Dose Intravenous Fentanyl 200 µg) and Single Doses of 2 or 3 mL AeroLEF (Liposome-Encapsulated Fentanyl 500 µg/mL) in Normal Healthy Non Subjects

Sponsor: YM BioSciences

Conditions Healthy

Interventions i.v. fentanyl and AeroLEF

Updated 5 times since 2017 Last updated: Jul 1, 2008 Started: Oct 31, 2001 Primary completion: Nov 30, 2001 Completion: Jun 30, 2002

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Healthy and is currently completed. YM BioSciences leads this study, which shows 5 recorded versions since 2001 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

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.

Status Flow

Change History

5 versions recorded

Jan 2026 — Present [monthly]

Completed PHASE1
Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jan 2017 — Jan 2021 [monthly]

Completed PHASE1

First recorded

Oct 2001

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

YM BioSciences

Data source: YM BioSciences

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Toronto, Canada