Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-01-02 @ 7:52 AM
Study NCT ID:
NCT00847418
Status:
COMPLETED
Last Update Posted:
2010-12-02
First Post:
2009-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-01', 'studyFirstSubmitDate': '2009-02-18', 'studyFirstSubmitQcDate': '2009-02-18', 'lastUpdatePostDateStruct': {'date': '2010-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'ketamine', 'Anesthetics, Dissociative'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is the determination of blood concentration and the effectiveness of esketamine after nasal application.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male\n* age ≥18 years ≤ 45 years\n* healthy\n* non-smoking\n* BMI 18-27\n\nExclusion Criteria:\n\n* abuse of drugs\n* known or supposed hypersensitivity and/or contraindication against ketamine or additives\n* participation of another clinical study within the last 30 days\n* chronic obstructed nose breathing or nasal polyps\n* dug allergy\n* blood donation within the last two months'}, 'identificationModule': {'nctId': 'NCT00847418', 'briefTitle': 'Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine', 'orgStudyIdInfo': {'id': 'EKBB 351/08, 2009DR1015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esketamine', 'interventionNames': ['Drug: esketamine hydrochloride']}], 'interventions': [{'name': 'esketamine hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['Esketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'Clinical Research Center, University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Manuel Haschke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Pharmacology and Toxicology, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Qualified Person, Stefanie Deuster, PhD.', 'oldOrganization': 'Hospital Pharmacy, University Hospital Basel, Switzerland.'}}}}