Overview

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

Status:
Completed
Trial end date:
2002-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
YM BioSciences
Treatments:
Fentanyl
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.