Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-28 @ 5:28 PM
Study NCT ID:
NCT01014650
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2009-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Ascending Dose Safety, Tolerability and Pharmacokinetics Study of GLYX-13 in Normal Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C507283', 'term': 'GLYX-13 peptide'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-18', 'studyFirstSubmitDate': '2009-11-13', 'studyFirstSubmitQcDate': '2009-11-14', 'lastUpdatePostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observed and laboratory-confirmed safety', 'timeFrame': 'four weeks'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration of parent drug will be assessed over time to estimate duration of pharmacodynamics in future efficacy trials. Plasma concentration and pharmacokinetics will be related in time to observed side effects.', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glycine site partial agonist', 'normal volunteers', 'safety in normal volunteers'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '25782764', 'type': 'DERIVED', 'citation': 'Preskorn S, Macaluso M, Mehra DO, Zammit G, Moskal JR, Burch RM; GLYX-13 Clinical Study Group. Randomized proof of concept trial of GLYX-13, an N-methyl-D-aspartate receptor glycine site partial agonist, in major depressive disorder nonresponsive to a previous antidepressant agent. J Psychiatr Pract. 2015 Mar;21(2):140-9. doi: 10.1097/01.pra.0000462606.17725.93.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of a single IV dose of GLYX-13, an N-Methyl-D-aspartate (NMDA) receptor glycine site functional partial agonist, in normal, healthy human volunteers.', 'detailedDescription': "NMDA receptor glycine site partial agonists (GFPAs) have been demonstrated to be efficacious in animal models and/or in early human studies of several Central Nervous System (CNS) diseases including neuropathic pain, major depressive disorder, schizophrenia, Alzheimer's disease, anxiety including posttraumatic stress syndrome, and cognition in Down's syndrome and autism and others, without the psychomimetic side effects of NMDA receptor channel blockers. GLYX-13 has demonstrated a wide therapeutic ratio (500:1) between efficacy and side effects in animals. The purpose of this study is to evaluate the safety and pharmacokinetics of GLYX-13 following a single IV dose."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical laboratory values \\< 2x the upper limit of normal\n* ability to understand the requirements of the study and provide informed consent\n\nExclusion Criteria:\n\n* alcohol abuse\n* abuse of illicit substances\n* current smoker\n* currently taking prescription medications (other than for birth control)\n* history of allergy to NMDA receptor ligands\n* received another investigational drug within 30 days\n* psychiatric disease'}, 'identificationModule': {'nctId': 'NCT01014650', 'briefTitle': 'Single Ascending Dose Safety, Tolerability and Pharmacokinetics Study of GLYX-13 in Normal Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Naurex, Inc, an affiliate of Allergan plc'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Single Intravenous Dose, Ascending Dose Level Study of the Safety, Tolerability and Pharmacokinetics of GLYX-13 in Normal Healthy Volunteers', 'orgStudyIdInfo': {'id': 'GLYX13-C-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'IV normal saline', 'description': 'Single IV dose of normal saline as a control for safety and tolerability observations', 'interventionNames': ['Drug: IV normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'IV GLYX-13', 'description': 'Single IV dose of GLYX-13', 'interventionNames': ['Drug: GLYX-13']}, {'type': 'EXPERIMENTAL', 'label': 'SC GLYX-13', 'description': 'Single SC dose', 'interventionNames': ['Drug: GLYX-13']}], 'interventions': [{'name': 'GLYX-13', 'type': 'DRUG', 'otherNames': ['NMDA receptor glycine site partial agonist'], 'description': 'single IV or SC dose', 'armGroupLabels': ['IV GLYX-13', 'SC GLYX-13']}, {'name': 'IV normal saline', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Single IV dose of normal saline', 'armGroupLabels': ['IV normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Lotus Clinical Research', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Neil Singla, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lotus Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Naurex, Inc, an affiliate of Allergan plc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}