Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-25 @ 7:06 PM
Study NCT ID:
NCT00544934
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
2007-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Dose Trial of Anti-glycation Agent GLY-230 in Healthy and Diabetic Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C518289', 'term': '2-(3-chlorophenylamino)phenylacetic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-09', 'studyFirstSubmitDate': '2007-10-15', 'studyFirstSubmitQcDate': '2007-10-15', 'lastUpdatePostDateStruct': {'date': '2016-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glycated albumimin concentration', 'timeFrame': 'three weeks'}], 'secondaryOutcomes': [{'measure': 'urine albumin', 'timeFrame': 'three weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Nephropathy']}, 'descriptionModule': {'briefSummary': 'A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nondiabetic and diabetic men age 18-55, engative drug screen, normal EKG, clinical chemistries. hematology parameters, HbA1c 7.5% if diabetic, give written informed consent\n\nExclusion Criteria:\n\n* Sctive concomitant serious medical or surgical disease'}, 'identificationModule': {'nctId': 'NCT00544934', 'briefTitle': 'Multiple Dose Trial of Anti-glycation Agent GLY-230 in Healthy and Diabetic Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glycadia'}, 'officialTitle': 'A Dose-ranging Study to Evaluate the Safety, Metabolism and Therapeutic Dosing of Three Multiple Dose Levels of GLY-230 in Healthy and Diabetic Subjects', 'orgStudyIdInfo': {'id': 'GLY-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '250 mg', 'interventionNames': ['Drug: GLY-230']}, {'type': 'EXPERIMENTAL', 'label': '500 mg', 'interventionNames': ['Drug: GLY-230']}, {'type': 'EXPERIMENTAL', 'label': '750 mg', 'interventionNames': ['Drug: GLY-230']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'GLY-230', 'type': 'DRUG', 'description': '125, 250 0r 375 mg bid for 14 days', 'armGroupLabels': ['250 mg', '500 mg', '750 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'No drug administered', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Laurence Kennedy, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}, {'name': 'Maria del Pilar Solano, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami, Miami, Florida'}, {'name': 'Lis Cohen, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Suncoast Clinical Research, New Port Richey, Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glycadia', 'class': 'INDUSTRY'}}}}