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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00708318
Recruitment Status : Completed
First Posted : July 2, 2008
Last Update Posted : July 2, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: i.v. fentanyl and AeroLEF Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2001
Actual Primary Completion Date : November 2001
Actual Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A, B, C Drug: i.v. fentanyl and AeroLEF

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.

Other Names:
  • Ionsys
  • Depodur
  • fetanyl

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: continuously ]

Secondary Outcome Measures :
  1. pharmacokinetics [ Time Frame: various time points ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00708318

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Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M1L4S4
Sponsors and Collaborators
YM BioSciences
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Study Director: Diana Pilura, PhD YM BioSciences
Principal Investigator: Paul Y Tam, MD, FACP University of Toronto, Ontario, Canada
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Responsible Party: Ali Raza, Chief Medical Officer, YM BioSciences Identifier: NCT00708318    
Other Study ID Numbers: LEF-2494
First Posted: July 2, 2008    Key Record Dates
Last Update Posted: July 2, 2008
Last Verified: July 2008
Keywords provided by YM BioSciences:
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General