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Sponsored by: |
YM BioSciences |
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Information provided by: | YM BioSciences |
ClinicalTrials.gov Identifier: | NCT00709254 |
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.
Condition | Intervention | Phase |
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Healthy |
Drug: i.v. fentanyl Drug: 3 mL AeroLEF (500 µg/1 mL) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Phase I, 3-Period, Fasting, Bioavailability, Safety Assessment and PK Study Evaluating Single Dose Administration of i.v. Fentanyl (200 µg) and Single and Multiple Doses of 3 mL of Inhaled AeroLEF (Liposome-Encapsulated Fentanyl 500 µg/mL) Administered in Normal Healthy Subjects |
Enrollment: | 12 |
Study Start Date: | December 2001 |
Study Completion Date: | January 2002 |
Primary Completion Date: | January 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Treatment Group A: Active Comparator
Subjects received an i.v. dose of fentanyl (200 µg)
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Drug: i.v. fentanyl
single dose, 200 ug
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Treatment Group B: Experimental
Subjects received a single dose of 3 mL AeroLEF (500 µg/1 mL)
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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)
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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
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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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
University of Toronto | |
Toronto, Ontario, Canada |
Study Director: | Diana Pilura, PhD | YM BioSciences |
Principal Investigator: | Paul Y Tam, MD, FACP | University of Toronto, Ontario, Canada |
Responsible Party: | YM BioSciences ( Ali Raza, Chief Medical Officer ) |
Study ID Numbers: | LEF-2495 |
Study First Received: | July 1, 2008 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00709254 |
Health Authority: | Canada: Health Canada |
AeroLEF fentanyl pharmacokinetics liposome encapsulated |
Fentanyl Citric Acid Healthy |
Anesthetics, Intravenous Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Narcotics Pharmacologic Actions Adjuvants, Anesthesia |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |