Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-30 @ 7:36 AM
Study NCT ID:
NCT00520169
Status:
COMPLETED
Last Update Posted:
2008-01-10
First Post:
2007-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-09', 'studyFirstSubmitDate': '2007-08-21', 'studyFirstSubmitQcDate': '2007-08-22', 'lastUpdatePostDateStruct': {'date': '2008-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ketamine pharmacokinetics', 'timeFrame': 'multiple'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioavailability'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.', 'detailedDescription': 'To examine the safety and assess the absolute bioavailability and nasopharyngeal absorption of PMI-150 30mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults\n\nExclusion Criteria:\n\n* under 18 years'}, 'identificationModule': {'nctId': 'NCT00520169', 'briefTitle': 'Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Javelin Pharmaceuticals'}, 'officialTitle': 'A Randomized, Open Label, Single Center, Single-Dose, Cross-Over Study to Determine the Absolute Bioavailability and the Nasopharyngeal Absorption of PMI-150 (Intranasal Ketamine) in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'KET-PK-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'oral ketamine', 'interventionNames': ['Drug: intranasal ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'intranasal ketamine', 'interventionNames': ['Drug: intranasal ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C', 'description': 'intravenous ketamine', 'interventionNames': ['Drug: intranasal ketamine']}], 'interventions': [{'name': 'intranasal ketamine', 'type': 'DRUG', 'description': 'A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.', 'armGroupLabels': ['A', 'B', 'C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02140', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Javelin Pharmaceuticals', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Javelin Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Javelin Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Javelin Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Javelin Pharmaceuticals', 'oldOrganization': 'Javelin Pharmaceuticals'}}}}