Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT01722669
Status:
COMPLETED
Last Update Posted:
2020-10-12
First Post:
2012-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Quercetin PK/PD Study in Healthy Adults and Patients With Hypercoagulable States
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C016527', 'term': 'isoquercitrin'}, {'id': 'D011794', 'term': 'Quercetin'}], 'ancestors': [{'id': 'D044948', 'term': 'Flavonols'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jzwicker@bidmc.harvard.edu', 'phone': '617-667-9299', 'title': 'Jeffrey Zwicker, Division of Thrombosis and Haemostasis, Division of Hematology and Oncology', 'organization': 'Beth Israel Deaconess Medical Center, Harvard Medical School'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Assessed during visit 1, up to 24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Quercetin 500 mg (ARM A1)', 'description': 'Toxicity over 24 hours following single dose', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Isoquercetin 500 mg (ARM B1)', 'description': 'Toxicity over 24 hours following single dose', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Quercetin 500 mg + Ascorbic Acid (ARM A2)', 'description': 'Toxicity over 24 hours following single dose of combined quercetin and ascorbic acid', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Isoquercetin 500 mg + Ascorbic Acid (ARM B2)', 'description': 'Toxicity over 24 hours following single dose of combined isoquercetin and ascorbic acid', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Isoquercetin 1000 mg + Ascorbic Acid (ARM C)', 'description': 'Toxicity over 24 hours following single dose of isoquercetin', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Antiphospholipid Antibody (ARM D)', 'description': 'Toxicity over 24 hours following single dose of isoquercetin', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Quercetin 500 mg (ARM A1)', 'description': 'Single dose, measurement of plasma quercetin aglycone'}, {'id': 'OG001', 'title': 'Isoquercetin 500 mg (ARM B1)', 'description': 'Single dose, measurement of plasma quercetin aglycone'}, {'id': 'OG002', 'title': 'Quercetin 500 mg + Ascorbic Acid (ARM A2)', 'description': 'Single dose, measurement of plasma quercetin aglycone'}, {'id': 'OG003', 'title': 'Isoquercetin 500 mg + Ascorbic Acid (ARM B2)', 'description': 'Single dose, measurement of plasma quercetin aglycone'}, {'id': 'OG004', 'title': 'Isoquercetin 1000 mg + Ascorbic Acid (ARM C)', 'description': 'Single dose, measurement of plasma quercetin aglycone'}], 'classes': [{'categories': [{'measurements': [{'value': '4.78', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '15.00', 'spread': '8.94', 'groupId': 'OG001'}, {'value': '5.41', 'spread': '2.13', 'groupId': 'OG002'}, {'value': '16.34', 'spread': '10.08', 'groupId': 'OG003'}, {'value': '40.3', 'spread': '17.11', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'AUC 0-24 hours of measured plasma quercetin aglycone for Arms A1, B1, A2, B2, C Collected at timepoints: baseline and 1, 2, 4, 6, 8, and 24 hours after dose. PK and PDI samples were not measured for Arm D (anti-phospholipid antibody cohort)', 'unitOfMeasure': 'uM hr/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reductase Activity of PDI Using Dieosin Glutathione Disulfide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Quercetin 500 mg (ARM A1)', 'description': 'PDI activity measured by DiESSG assay at 0 and 2 hours'}, {'id': 'OG001', 'title': 'Isoquercetin 500 mg (ARM B1)', 'description': 'PDI activity measured by DiESSG assay at 0 and 2 hours'}, {'id': 'OG002', 'title': 'Quercetin 500 mg + Ascorbic Acid (ARM A2)', 'description': 'PDI activity measured by DiESSG assay at 0 and 2 hours'}, {'id': 'OG003', 'title': 'Isoquercetin 500 mg + Ascorbic Acid (ARM B2)', 'description': 'PDI activity measured by DiESSG assay at 0 and 2 hours'}, {'id': 'OG004', 'title': 'Isoquercetin 1000 mg + Ascorbic Acid (ARM C)', 'description': 'PDI activity measured by DiESSG assay at 0 and 2 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '31.9', 'spread': '24.14', 'groupId': 'OG000'}, {'value': '63.2', 'spread': '25.3', 'groupId': 'OG001'}, {'value': '16', 'spread': '31.8', 'groupId': 'OG002'}, {'value': '8.3', 'spread': '15.03', 'groupId': 'OG003'}, {'value': '38', 'spread': '35', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours. Not measured in D', 'description': 'Measurement of protein disulfide inhibition in plasma using a fluorescent PDI substrate (dieosin glutathione disulfide)', 'unitOfMeasure': 'Percent inhibition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 hours after oral ingestion'}, {'type': 'SECONDARY', 'title': 'Platelet-induced Thrombin Generation (U/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isoquercetin 1000 mg + Ascorbic Acid (ARM C)', 'description': 'Thrombin induced thrombin generation measured before and after isoquercetin + Ascorbic acid at time 0 and 4 hours'}, {'id': 'OG001', 'title': 'Antiphospholipid Antibody (ARM D)', 'description': 'Thrombin induced thrombin generation measured at time 0 and 4 hours following isoquercetin 1000 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'spread': '.28', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'description': 'Thrombin induced thrombin generation measured in patient plasma', 'unitOfMeasure': 'U/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '4 hours after single dose only measured in Arm C and Arm D'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Quercetin 500mg (ARM A1)', 'description': 'Single dose PK/PD analyses of quercetin 500 mg'}, {'id': 'FG001', 'title': 'Isoquercetin 500mg (ARM B1)', 'description': 'Single dose PK/PD of isoquercetin 500 mg'}, {'id': 'FG002', 'title': 'Quercetin 500 mg + Ascorbic Acid (ARM A2)', 'description': 'Single dose quercetin with 500 mg + ascorbic acid pk/pd analyses'}, {'id': 'FG003', 'title': 'Isoquercetin 500 mg + Ascorbic Acid (ARM B2)', 'description': 'Single dose isoquercetin 500 mg + ascorbic acid pk/pd analyses'}, {'id': 'FG004', 'title': 'Isoquercetin 1000 mg + Ascorbic Acid (ARM C)', 'description': 'Single dose isoquercetin + 1000 mg ascorbic acid'}, {'id': 'FG005', 'title': 'Antiphospholipid Antibody Cohort (ARM D)', 'description': 'Single dose isoquercetin 1000 mg + 1000 mg ascorbic acid in patients with antiphospholipid antibodies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'comment': 'Antiphospholipid Antibody (ARM D): 6 evaluable and 2 withdrew consent without any data collected', 'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Quercetin 500 mg (ARM A1)', 'description': 'Single dose of quercetin PK/PD analysis'}, {'id': 'BG001', 'title': 'Isoquercetin 500 mg (ARM B1)', 'description': 'Single dose of isoquercetin PK/PD analysis'}, {'id': 'BG002', 'title': 'Quercetin 500 mg + Ascorbic Acid (ARM A2)', 'description': 'Single dose of quercetin + ascorbic acid PK/PD analysis'}, {'id': 'BG003', 'title': 'Isoquercetin 500 mg + Ascorbic Acid (ARM B2)', 'description': 'Single dose of isqouercetin +ascorbic acid PK/PD analysis'}, {'id': 'BG004', 'title': 'Isoquercetin 1000 mg + Ascorbic Acid (ARM C)', 'description': 'single dose isoquercetin + ascorbic acid PK/PD analyses'}, {'id': 'BG005', 'title': 'Antiphospholipid Antibody (ARM D)', 'description': 'single dose isoquercetin +ascorbic acid in patients with antiphospholipid antibodies'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected'}], 'populationDescription': 'Measure Analysis Population Description: Antiphospholipid Antibody (ARM D): 2 withdrew consent without any data collected'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-26', 'size': 504323, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-06T12:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-09', 'studyFirstSubmitDate': '2012-05-10', 'resultsFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2012-11-05', 'lastUpdatePostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-09', 'studyFirstPostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': '24 hours', 'description': 'AUC 0-24 hours of measured plasma quercetin aglycone for Arms A1, B1, A2, B2, C Collected at timepoints: baseline and 1, 2, 4, 6, 8, and 24 hours after dose. PK and PDI samples were not measured for Arm D (anti-phospholipid antibody cohort)'}], 'secondaryOutcomes': [{'measure': 'Reductase Activity of PDI Using Dieosin Glutathione Disulfide', 'timeFrame': '2 hours. Not measured in D', 'description': 'Measurement of protein disulfide inhibition in plasma using a fluorescent PDI substrate (dieosin glutathione disulfide)'}, {'measure': 'Platelet-induced Thrombin Generation (U/mL)', 'timeFrame': '4 hours', 'description': 'Thrombin induced thrombin generation measured in patient plasma'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quercetin', 'isoquercetin', 'pharmacokinetic', 'pharmacodynamic'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '28097231', 'type': 'DERIVED', 'citation': 'Stopa JD, Neuberg D, Puligandla M, Furie B, Flaumenhaft R, Zwicker JI. Protein disulfide isomerase inhibition blocks thrombin generation in humans by interfering with platelet factor V activation. JCI Insight. 2017 Jan 12;2(1):e89373. doi: 10.1172/jci.insight.89373.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate how much quercetin or isoquercetin is absorbed after a single dose and evaluate for pharmacokinetic inhibition of protein disulfide isomerase. Pharmacodynamic studies will also be performed in an additional cohort of 10 patients with evidence of antiphospholipid antibodies', 'detailedDescription': 'To compare the absorption and activity of quercetin or isoquercetin with or without ascorbic acid in healthy adults. Oral chews containing quercetin (500mg) or isoquercetin(500 mg total) with or without ascorbic acid will be given. Pharmacokinetic parameters (AUC, Cmax, Tmax, elimination half-life) will be determined over 24 hours (8 time points). Pharmacodynamic inhibition of protein disulfide isomerase activity will also be assessed.\n\nIn addition to healthy subjects, a cohort of 10 individuals with antiphospholipid antibodies will participate. These participants will receive isoquercetin 1000 mg and have pharmacodynamics studies performed at time 0 and 4 hours.\n\nAll study drugs will be provided by Quercegen Pharma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Subject is willing to participate and provide informed consent\n* Subject is considered reliable and capable of adhering to the protocol per the judgment of the Investigator\n* Subjects in group D must exhibit good organ reserves (within prior 4 weeks) defined as:\n\n 1. Estimated GFR \\>35 (formula),\n 2. Platelet count \\>65 K/uL,\n 3. Hemoglobin \\>10.5 grams/dL\n 4. Total bilirubin \\<2.0 mg/dL\n* Minimum age 18 years old\n* Body mass index (BMI) between 18 and 35 kg/m2\n* For cohort D (antiphospholipid antibodies) a. Subjects in group D must have at least one positive antiphospholipid antibody within the last 8 weeks and/or previous confirmed antibodies (2 or more occasions at least 12 weeks apart) : i. Positive lupus anticoagulant ii. anticardiolipin antibody IgM or IgG (\\>40U GPL) iii. anti-β2 Glycoprotein1 antibody titer (\\>35 units)\n\nExclusion Criteria\n\n* Pregnant. If female of child-bearing age, negative urinary pregnancy test prior to dosing of quercetin or isoquercetin\n* No history of malabsorptive gastrointestinal disorder\n* Currently taking aspirin, NSAIDS, warfarin, low-molecular weight heparin or other anticoagulants (such as direct thrombin inhibitors or factor X inhibitors)\n\n a. Note: Study subjects taking aspirin or NSAIDS, if treating physician concurs, are permitted to enroll if plan to hold for aspirin 10 days or NSAIDS 24 hours prior to dosing of quercetin/isoquercetin\n* Prescribed niacin for hyperlipidemia\n* Known HIV\n* History of sensitivity or intolerance to flavonoids, niacin or ascorbic acid\n* May not have uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia'}, 'identificationModule': {'nctId': 'NCT01722669', 'acronym': 'PK/PD', 'briefTitle': 'Quercetin PK/PD Study in Healthy Adults and Patients With Hypercoagulable States', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Pharmacokinetic and Pharmacodynamic Study of Oral Quercetin and Isoquercetin in Healthy Adults and Patients With Hypercoagulable States.', 'orgStudyIdInfo': {'id': '2012P000022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quercetin', 'description': 'Single dose of quercetin with or without ascorbic acid', 'interventionNames': ['Drug: isoquercetin or quercetin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Isoquercetin', 'description': 'Single dose of isoquercetin with or without ascorbic acid', 'interventionNames': ['Drug: isoquercetin or quercetin']}], 'interventions': [{'name': 'isoquercetin or quercetin', 'type': 'DRUG', 'description': 'Single dose PK/PD study', 'armGroupLabels': ['Isoquercetin', 'Quercetin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jeffrey Zwicker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '3 years', 'ipdSharing': 'YES', 'description': 'Contact PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Harvard Medical School', 'investigatorFullName': 'Jeff Zwicker', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}