Study of Single and Multiple Doses of Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Healthy Subjects (LEF-2495)
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ClinicalTrials.gov Identifier: NCT00709254 |
Recruitment Status :
Completed
First Posted : July 3, 2008
Last Update Posted : July 3, 2008
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: i.v. fentanyl Drug: 3 mL AeroLEF (500 µg/1 mL) | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I, 3-Period, Fasting, Bioavailability, Safety Assessment and PK Study Evaluating Single Dose Administration of i.v. Fentanyl (200 µg) and Single and Multiple Doses of 3 mL of Inhaled AeroLEF (Liposome-Encapsulated Fentanyl 500 µg/mL) Administered in Normal Healthy Subjects |
Study Start Date : | December 2001 |
Actual Primary Completion Date : | January 2002 |
Actual Study Completion Date : | January 2002 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Treatment Group A
Subjects received an i.v. dose of fentanyl (200 µg)
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Drug: i.v. fentanyl
single dose, 200 ug
Other Name: fetanyl citrate injection |
Experimental: Treatment Group B
Subjects received a single dose of 3 mL AeroLEF (500 µg/1 mL)
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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)
Other Name: Aerosolized Free and Liposome-Encapsulated Fentanyl |
Experimental: Treatment Group C
Subjects received multiple doses of 3 mL AeroLEF (500 µg/1 mL) every 12 hours for a total of five doses over a 3 days
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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
Other Name: Aerosolized Free and Liposome-Encapsulated Fentanyl |
- Adverse Events [ Time Frame: continuously ]
- pharmacokinetics and bioavailability [ Time Frame: various time points ]

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT00709254
Canada, Ontario | |
University of Toronto | |
Toronto, Ontario, Canada |
Study Director: | Diana Pilura, PhD | YM BioSciences | |
Principal Investigator: | Paul Y Tam, MD, FACP | University of Toronto, Ontario, Canada |
Responsible Party: | Ali Raza, Chief Medical Officer, YM BioSciences |
ClinicalTrials.gov Identifier: | NCT00709254 |
Other Study ID Numbers: |
LEF-2495 |
First Posted: | July 3, 2008 Key Record Dates |
Last Update Posted: | July 3, 2008 |
Last Verified: | July 2008 |
AeroLEF fentanyl pharmacokinetics liposome encapsulated |
Fentanyl Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics |
Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |