Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-21 @ 1:51 AM
Study NCT ID:
NCT01856556
Status:
COMPLETED
Last Update Posted:
2016-01-26
First Post:
2013-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-25', 'studyFirstSubmitDate': '2013-05-13', 'studyFirstSubmitQcDate': '2013-05-16', 'lastUpdatePostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observed and laboratory-confirmed safety', 'timeFrame': '28 days'}], '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': True}, 'conditionsModule': {'keywords': ['safety', 'tolerability', 'pharmacokinetics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and tolerability of a single intravenous (IV) and oral (PO) ascending dose of NRX-1074 as evidenced by the incidence and severity of adverse events (AEs), changes in serum chemistry, hematology, and urinalysis, changes in physical examination findings and subject-reported symptoms.\n\nThe secondary objectives of this study are to assess the plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK), the oral bioavailability of experimental formulations and the renal elimination through urine concentration of NRX-1074 through 24 hours following dosing.', 'detailedDescription': 'Randomized, double-blind, placebo-controlled, single ascending dose level study. On Day 1, eligibility of each subject will be confirmed, physical examination will be performed, and blood and urine for laboratories will be obtained. Each subject will be randomized, then will receive either a single IV, SC or IN dose of GLYX-13 or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female subjects\n2. Aged 18 to 55 years\n3. For female subjects, surgically sterile or at least 2 years menopausal, or using an acceptable method of birth control from date of screening to at least 30 days after the last dose of study drugIf of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours prior to dosing.\n4. Clinical laboratory values less than or equal to 2 times the upper limit of normal (ULN) or deemed not clinically significant by the Investigator.\n5. Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01856556', 'briefTitle': 'Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Naurex, Inc, an affiliate of Allergan plc'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Single Intravenous and Oral Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers', 'orgStudyIdInfo': {'id': 'NRX1074-C-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NRX-1074, 1 mg', 'description': '1 mg IV', 'interventionNames': ['Drug: NRX-1074']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'NRX-1074, 5 mg', 'description': '5 mg IV', 'interventionNames': ['Drug: NRX-1074']}, {'type': 'EXPERIMENTAL', 'label': 'NRX-1074, 10 mg IV', 'description': '10 mg', 'interventionNames': ['Drug: NRX-1074']}, {'type': 'EXPERIMENTAL', 'label': 'NRX-1074, 50 mg IV', 'description': '50 mg', 'interventionNames': ['Drug: NRX-1074']}, {'type': 'EXPERIMENTAL', 'label': 'NRX-1074, 25 mg PO', 'description': '25 mg', 'interventionNames': ['Drug: NRX-1074']}, {'type': 'EXPERIMENTAL', 'label': 'NRX-1074, 125 mg PO', 'description': '125 mg', 'interventionNames': ['Drug: NRX-1074']}], 'interventions': [{'name': 'NRX-1074', 'type': 'DRUG', 'otherNames': ['NMDA receptor functional glycine-site partial agonist'], 'description': 'Single IV or PO administration', 'armGroupLabels': ['NRX-1074, 1 mg', 'NRX-1074, 10 mg IV', 'NRX-1074, 125 mg PO', 'NRX-1074, 25 mg PO', 'NRX-1074, 5 mg', 'NRX-1074, 50 mg IV']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single IV or PO placebo administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Lotus Clinical Research', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Grace Ting, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lotus Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Naurex, Inc, an affiliate of Allergan plc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}