Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT00708318
Status:
COMPLETED
Last Update Posted:
2008-07-02
First Post:
2008-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Normal Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-01', 'studyFirstSubmitDate': '2008-07-01', 'studyFirstSubmitQcDate': '2008-07-01', 'lastUpdatePostDateStruct': {'date': '2008-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'continuously'}], 'secondaryOutcomes': [{'measure': 'pharmacokinetics', 'timeFrame': 'various time points'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AeroLEF', 'fentanyl', 'pharmacokinetic', 'liposome', 'encapsulated'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Non-smoking male or female with a minimum age of at least 18 years\n* Body weight with aBMI range of 18.5 - 27, with a minimum weight of at least 60 kg.\n* Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed, written, Informed Consent Form.\n* 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.\n* Negative for drug abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and HIV.\n* If a female of child-bearing potential, the patient must have a negative urine pregnancy test at screening and baseline.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Known history of hypersensitivity to fentanyl.\n* 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.\n* History of drug abuse or narcotic dependency.\n* Use of prescription medication within 30 days preceding entry int the study, including any enzyme inducing/inhibitory drugs (excluding contraceptives).\n* Participating in a clinical trial with an investigational drug within 30 days preceding this trial.\n* Blood donation within 45 days preceding this trial."}, 'identificationModule': {'nctId': 'NCT00708318', 'briefTitle': 'Study Evaluating Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Normal Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'YM BioSciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'LEF-2494'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A, B, C', 'interventionNames': ['Drug: i.v. fentanyl and AeroLEF']}], 'interventions': [{'name': 'i.v. fentanyl and AeroLEF', 'type': 'DRUG', 'otherNames': ['Ionsys', 'Depodur', 'fetanyl'], 'description': 'Period I: subjects received an intravenous dose of fentanyl (200 µg) (Treatment A).\n\nPeriod II: subjects were randomly assigned to receive either 2 mL (Treatment B) or 3mL (Treatment C) of AeroLEF delivered by nebulization with an AeroEclipse BAN.', 'armGroupLabels': ['A, B, C']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M1L4S4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Diana Pilura, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'YM BioSciences'}, {'name': 'Paul Y Tam, MD, FACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto, Ontario, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'YM BioSciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Ali Raza, Chief Medical Officer', 'oldOrganization': 'YM BioSciences'}}}}