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

Information source: YM BioSciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: i.v. fentanyl and AeroLEF (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: YM BioSciences

Official(s) and/or principal investigator(s):
Diana Pilura, PhD, Study Director, Affiliation: YM BioSciences
Paul Y Tam, MD, FACP, Principal Investigator, Affiliation: University of Toronto, Ontario, Canada

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Adverse Events

Secondary outcome: pharmacokinetics

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University of Toronto, Toronto, Ontario M1L4S4, Canada
Additional Information

Starting date: October 2001
Last updated: July 1, 2008

Page last updated: August 23, 2015

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