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

NCT00709254 | Completed Phase 1

• 1 other identifier: LEF-2495
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

AeroLEF; fentanyl; pharmacokinetics; liposome; encapsulated

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  continuously

Secondary Outcomes (1)

• pharmacokinetics and bioavailability

  various time points

Study Arms (3)

Treatment Group A

ACTIVE COMPARATOR

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

Drug: i.v. fentanyl

Treatment Group B

EXPERIMENTAL

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

Drug: 3 mL AeroLEF (500 µg/1 mL)

Treatment Group C

EXPERIMENTAL

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)

Interventions

i.v. fentanyl DRUG

single dose, 200 ug

Also known as: fetanyl citrate injection

Treatment Group A

3 mL AeroLEF (500 µg/1 mL) DRUG

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

Also known as: Aerosolized Free and Liposome-Encapsulated Fentanyl

Treatment Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.

Sponsors & Collaborators

• YM BioSciences: lead

Study Sites (1)

University of Toronto

Toronto, Ontario, Canada

Location

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: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: December 1, 2001
• Primary Completion: January 1, 2002
• Study Completion: January 1, 2002
• Last Updated: July 3, 2008

Record last verified: 2008-07

Locations

CA (1)