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

NCT ID: NCT00709254

Last Updated: 2008-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-31
• Study Completion Date: 2002-01-31

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.

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.

Conditions

Healthy

Keywords

AeroLEF; fentanyl; pharmacokinetics; liposome; encapsulated

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group A

Subjects received an i.v. dose of fentanyl (200 µg)

Group Type: ACTIVE_COMPARATOR

i.v. fentanyl

Intervention Type: DRUG

single dose, 200 ug

Treatment Group B

Subjects received a single dose of 3 mL AeroLEF (500 µg/1 mL)

Group Type: EXPERIMENTAL

3 mL AeroLEF (500 µg/1 mL)

Intervention Type: DRUG

A single dose of 3mL (500 µg/1 mL) of AeroLEF (Aerosolized Free and Liposome-Encapsulated Fentanyl)

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

Group Type: EXPERIMENTAL

3 mL AeroLEF (500 µg/1 mL)

Intervention Type: DRUG

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

Interventions

i.v. fentanyl

single dose, 200 ug

Intervention Type: 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)

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

fetanyl citrate injection; Aerosolized Free and Liposome-Encapsulated Fentanyl; Aerosolized Free and Liposome-Encapsulated Fentanyl

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

YM BioSciences

INDUSTRY

Sponsor Role: lead

Responsible Party

YM BioSciences

Principal Investigators

Diana Pilura, PhD

Role: STUDY_DIRECTOR

YM BioSciences

Paul Y Tam, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

University of Toronto, Ontario, Canada

Locations

University of Toronto

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

LEF-2495

Identifier Type: -

Identifier Source: org_study_id