Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-03-11 @ 7:00 AM
Study NCT ID:
NCT02331433
Status:
COMPLETED
Last Update Posted:
2016-04-08
First Post:
2014-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Pharmacokinetics of Single Doses of APN1125 in Healthy Normal Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-07', 'studyFirstSubmitDate': '2014-12-26', 'studyFirstSubmitQcDate': '2015-01-02', 'lastUpdatePostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of safety and tolerability of APN1125 in healthy subjects via adverse events', 'timeFrame': '8 days'}, {'measure': 'Assessment of safety and tolerability of APN1125 in healthy subjects via vital signs (e.g., blood pressure, pulse rate, respiratory rate, oral temperature)', 'timeFrame': '8 days'}, {'measure': 'Assessment of safety and tolerability of APN1125 in healthy subjects via ECGs', 'timeFrame': '8 days'}, {'measure': 'Assessment of safety and tolerability of APN1125 in healthy subjects via physical exams', 'timeFrame': '8 days'}, {'measure': 'Assessment of safety and tolerability of APN1125 in healthy subjects via clinical laboratory tests (chemistry, hematology, coagulation and urinalysis)', 'timeFrame': '8 days'}], 'secondaryOutcomes': [{'measure': 'Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: maximum observed plasma concentration (Cmax)', 'timeFrame': '24 hours'}, {'measure': 'Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: time corresponding to occurrence of Cmax (tmax)', 'timeFrame': '24 hours'}, {'measure': 'Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero to the last quantifiable concentration (AUClast)', 'timeFrame': '24 hours'}, {'measure': 'Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero extrapolated to infinity (AUCinf)', 'timeFrame': '24 hours'}, {'measure': 'Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: terminal elimination rate constant (lz)', 'timeFrame': '24 hours'}, {'measure': 'Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent elimination half-life (t1/2)', 'timeFrame': '24 hours'}, {'measure': 'Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent plasma clearance (CL/F)', 'timeFrame': '24 hours'}, {'measure': 'Assessment of pharmacokinetics of APN1125 in urine following single oral doses: apparent volume of distribution (Vz/F)', 'timeFrame': '24 hours'}, {'measure': 'Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion (Ae)', 'timeFrame': '24 hours'}, {'measure': 'Assessment of pharmacokinetics of APN1125 in urine following single oral doses: fraction of APN1125 dose excreted (Fe)', 'timeFrame': '24 hours'}, {'measure': 'Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion expressed as percentage of dose administered (Ae%)', 'timeFrame': '24 hours'}, {'measure': 'Assessment of pharmacokinetics of APN1125 in urine following single oral doses: renal clearance calculated as APN1125 (CLR)', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of APN1125 when administered as single doses to healthy adult subjects.', 'detailedDescription': 'The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, (2) effect of food upon pharmacokinetics of a single dose of APN1125 in healthy adult volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females\n* Aged 18 to 65 years, inclusive\n* Body mass index (BMI) of 18 to 32kg/m\\^2 inclusive at Screening\n* Non-smoker or no tobacco/nicotine usage with 30 days of Screening\n\nExclusion Criteria:\n\n* Personal or family history of neurological, cardiovascular, renal, hepatic, metabolic, gastrointestinal or endocrine abnormalities\n* Any clinical abnormality in cardiovascular (e.g., blood pressure) or electrocardiogram (ECG) parameters at Screening and check-in'}, 'identificationModule': {'nctId': 'NCT02331433', 'briefTitle': 'Safety, Tolerability, and Pharmacokinetics of Single Doses of APN1125 in Healthy Normal Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'CoMentis'}, 'officialTitle': 'A Phase 1 Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APN1125 in Healthy Normal Subjects', 'orgStudyIdInfo': {'id': 'APN1125-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: 1', 'interventionNames': ['Drug: APN1125']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator: 2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'APN1125', 'type': 'DRUG', 'description': 'APN1125 orally at ascending doses', 'armGroupLabels': ['Experimental: 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching Placebo', 'armGroupLabels': ['Placebo Comparator: 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'PAREXEL Early Phase', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], 'overallOfficials': [{'name': 'David Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'California Clinical Trials Medical Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CoMentis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Alpharmagen, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}