Status:
COMPLETED
Study Evaluating Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Normal Healthy Subjects
Lead Sponsor:
YM BioSciences
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
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 assigne...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2002
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00708318
Start Date
October 1 2001
End Date
June 1 2002
Last Update
July 2 2008
Active Locations (1)
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1
University of Toronto
Toronto, Ontario, Canada, M1L4S4