Study of Single and Multiple Doses of Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Healthy Subjects (LEF-2495)

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: i.v. fentanyl; Drug: 3 mL AeroLEF (500 µg/1 mL)	Phase 1

Detailed Description:

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 Design

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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

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Treatment Group A; Subjects received an i.v. dose of fentanyl (200 µg)	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)	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	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

Outcome Measures

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Primary Outcome Measures :

1. Adverse Events [ Time Frame: continuously ]

Secondary Outcome Measures :

1. pharmacokinetics and bioavailability [ Time Frame: various time points ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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Locations

Canada, Ontario
University of Toronto
Toronto, Ontario, Canada

Sponsors and Collaborators

YM BioSciences

Investigators

Study Director:	Diana Pilura, PhD	YM BioSciences
Principal Investigator:	Paul Y Tam, MD, FACP	University of Toronto, Ontario, Canada

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ali Raza, Chief Medical Officer, YM BioSciences
ClinicalTrials.gov Identifier:	NCT00709254 History of Changes
Other Study ID Numbers:	LEF-2495
First Posted:	July 3, 2008
Last Update Posted:	July 3, 2008
Last Verified:	July 2008

Keywords provided by YM BioSciences:

AeroLEF; fentanyl; pharmacokinetics; liposome; encapsulated

Additional relevant MeSH terms:

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