Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-29 @ 6:35 AM
Study NCT ID:
NCT03565861
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2018-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Adaptive design of placebo and up to six escalating doses of NP10679'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2018-05-29', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events as a measure of safety and tolerability', 'timeFrame': '8 days', 'description': 'Observed side effects and alteration in laboratory values.'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration of parent drug', 'timeFrame': '4 days', 'description': 'Cmax after administration.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety Issues']}, 'descriptionModule': {'briefSummary': 'This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.', 'detailedDescription': 'NP10679 is a pH dependent inhibitor of the GluN2B subtype of the NMDA receptor. Compounds of this drug class are hypothesized to be beneficial in a number of central nervous system disorders, including brain ischemia associated with subarachnoid hemorrhage, severe pain, major depression and substance abuse disorders. This study uses a double blind, adaptive design approach to evaluate the safety, tolerability and pharmacokinetics of a single dose of NP10679 when delivered intravenously in up to six escalating dose levels in comparison to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects aged 18 to 55 years\n* 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* If of child bearing potential (both men and women) must agree to use 2 forms of contraceptive methods for the duration of study.\n\nExclusion Criteria:\n\n* Clinical laboratory values greater than or equal to 2 times the upper limit of normal.\n* Recent history (within 2 yrs) or current tobacco use.'}, 'identificationModule': {'nctId': 'NCT03565861', 'briefTitle': 'Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurop Inc.'}, 'officialTitle': 'A Phase 1, Randomized , Double Blind, Single Ascending Dose Study to Investigate Safety, Tolerability and PK of NP10679 in Healthy Adults', 'orgStudyIdInfo': {'id': 'NP10679-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo intravenous 30 minute infusion on day 1', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'NP10679 5 mg', 'description': 'NP10679 5 mg intravenous infusion on day 1', 'interventionNames': ['Drug: NP10679']}, {'type': 'EXPERIMENTAL', 'label': 'NP10679 15 mg', 'description': 'NP10679 15 mg intravenous infusion on day 1', 'interventionNames': ['Drug: NP10679']}, {'type': 'EXPERIMENTAL', 'label': 'NP10679 50 mg', 'description': 'NP10679 50 mg intravenous infusion on day 1', 'interventionNames': ['Drug: NP10679']}, {'type': 'EXPERIMENTAL', 'label': 'NP10679 100 mg', 'description': 'NP10679 100 mg intravenous infusion on day 1', 'interventionNames': ['Drug: NP10679']}, {'type': 'EXPERIMENTAL', 'label': 'NP10679 200 mg', 'description': 'NP10679 200 mg intravenous infusion on day 1', 'interventionNames': ['Drug: NP10679']}, {'type': 'EXPERIMENTAL', 'label': 'NP10679 300 mg', 'description': 'NP10679 300 mg intravenous infusion on day 1', 'interventionNames': ['Drug: NP10679']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Intravenous vehicle', 'armGroupLabels': ['Placebo']}, {'name': 'NP10679', 'type': 'DRUG', 'description': 'NP10679', 'armGroupLabels': ['NP10679 100 mg', 'NP10679 15 mg', 'NP10679 200 mg', 'NP10679 300 mg', 'NP10679 5 mg', 'NP10679 50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pharmaron CPC', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Robert Zaczek, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Neurop Inc.'}, {'name': 'Paolo DePetrillo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pharmaron CPC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurop Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}