NCT00708318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2001

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2001

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
Last Updated

July 2, 2008

Status Verified

July 1, 2008

Enrollment Period

1 month

First QC Date

July 1, 2008

Last Update Submit

July 1, 2008

Conditions

Healthy

Keywords

AeroLEFfentanylpharmacokineticliposomeencapsulated

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    continuously

Secondary Outcomes (1)

  • pharmacokinetics

    various time points

Study Arms (1)

A, B, C

EXPERIMENTAL
Drug: i.v. fentanyl and AeroLEF

Interventions

i.v. fentanyl and AeroLEFDRUG

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.

Also known as: Ionsys, Depodur, fetanyl
A, B, C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M1L4S4, Canada

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Diana Pilura, PhD

    YM BioSciences

    STUDY DIRECTOR

  • Paul Y Tam, MD, FACP

    University of Toronto, Ontario, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 1, 2008

First Posted

July 2, 2008

Study Start

October 1, 2001

Primary Completion

November 1, 2001

Study Completion

June 1, 2002

Last Updated

July 2, 2008

Record last verified: 2008-07

Locations

CA(1)