Study of Single and Multiple Doses of Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Healthy Subjects (LEF-2495)
This study has been completed.
Sponsor:
YM BioSciences
Information provided by:
YM BioSciences
ClinicalTrials.gov Identifier:
NCT00709254
First received: July 1, 2008
Last updated: July 2, 2008
Last verified: July 2008
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Purpose
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 |
|---|---|---|
|
Healthy |
Drug: i.v. fentanyl Drug: 3 mL AeroLEF (500 µg/1 mL) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by YM BioSciences:
Primary Outcome Measures:
- Adverse Events [ Time Frame: continuously ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- pharmacokinetics and bioavailability [ Time Frame: various time points ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Active Comparator: Treatment Group A
Subjects received an i.v. dose of fentanyl (200 µg)
|
Drug: i.v. fentanyl
single dose, 200 ug
Other Name: fetanyl citrate injection
|
|
Experimental: Treatment Group B
Subjects received a single dose of 3 mL AeroLEF (500 µg/1 mL)
|
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)
Other Name: Aerosolized Free and Liposome-Encapsulated Fentanyl
|
|
Experimental: Treatment Group C
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)
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
Other Name: Aerosolized Free and Liposome-Encapsulated Fentanyl
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709254
Locations
| Canada, Ontario | |
| University of Toronto | |
| Toronto, Ontario, Canada | |
Sponsors and Collaborators
YM BioSciences
Investigators
| Study Director: | Diana Pilura, PhD | YM BioSciences |
| Principal Investigator: | Paul Y Tam, MD, FACP | University of Toronto, Ontario, Canada |
More Information
No publications provided
| Responsible Party: | Ali Raza, Chief Medical Officer, YM BioSciences |
| ClinicalTrials.gov Identifier: | NCT00709254 History of Changes |
| Other Study ID Numbers: | LEF-2495 |
| Study First Received: | July 1, 2008 |
| Last Updated: | July 2, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by YM BioSciences:
|
AeroLEF fentanyl pharmacokinetics liposome encapsulated |
Additional relevant MeSH terms:
|
Fentanyl Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 21, 2013