Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-13 @ 2:52 PM
Study NCT ID:
NCT03843502
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2019-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'r.nelson@ufl.edu', 'phone': '3522945563', 'title': 'Robyn Nelson', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '11 months', 'description': 'Reporting information follows clinicaltrials.gov guidelines', 'eventGroups': [{'id': 'EG000', 'title': 'Kava Pharmacokinetics Single Dose Group', 'description': '5 subjects will take three 75 mg kava dietary supplement capsules in a single dose/timepoint and nine blood draws will be collected over a twelve hour period following administration of kava.\n\nKava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Kava Pharmacokinetics 3x a Day Dose Group', 'description': '5 subjects will take three 75 mg kava dietary supplement capsules split among three time points during the study visit. Nine blood draws will be collected over a twelve hour study period.\n\nKava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Itching two days post dose', 'notes': 'Itching two days post dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Maximum Concentration of Kava in the Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kava Pharmacokinetics Single Dose Group', 'description': '5 subjects will take three 75 mg kava dietary supplement capsules in a single dose/timepoint and nine blood draws will be collected over a twelve hour period following administration of kava.\n\nKava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs.'}, {'id': 'OG001', 'title': 'Kava Pharmacokinetics 3x a Day Dose Group', 'description': '5 subjects will take three 75 mg kava dietary supplement capsules split among three time points during the study visit. Nine blood draws will be collected over a twelve hour study period.\n\nKava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs'}], 'classes': [{'title': 'Kavain', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Dihydrokavain', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Methysticin', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Dihydromethysticin', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Yangonin', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose to 12 hours post-dose', 'description': 'Number of hours that it takes for kava metabolites to reach the maximum concentration in the blood based on multiple blood draws over a 12 hour period', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '10 healthy participants were included in the analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Kava Pharmacokinetics Single Dose Group', 'description': '5 subjects will take three 75 mg kava dietary supplement capsules in a single dose/timepoint and nine blood draws will be collected over a twelve hour period following administration of kava.\n\nKava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs.'}, {'id': 'FG001', 'title': 'Kava Pharmacokinetics 3x a Day Dose Group', 'description': '5 subjects will take three 75 mg kava dietary supplement capsules split among three time points during the study visit. Nine blood draws will be collected over a twelve hour study period.\n\nKava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Individuals were recruitment for this study via flyers placed in various location in and around the Gainesville area.', 'preAssignmentDetails': 'Any individuals who were found to have a positive urine drug screen, had abnormal lab values, or were found to have active suicidal ideation were excluded from the study prior to baseline.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Kava Pharmacokinetics Single Dose Group', 'description': '5 subjects will take three 75 mg kava dietary supplement capsules in a single dose/timepoint and nine blood draws will be collected over a twelve hour period following administration of kava.\n\nKava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs.'}, {'id': 'BG001', 'title': 'Kava Pharmacokinetics 3x a Day Dose Group', 'description': '5 subjects will take three 75 mg kava dietary supplement capsules split among three time points during the study visit. Nine blood draws will be collected over a twelve hour study period.\n\nKava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '22'}, {'value': '21', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '40'}, {'value': '21', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-11', 'size': 505461, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-30T09:56', 'hasProtocol': True}, {'date': '2021-01-11', 'size': 3229001, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-20T15:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2019-02-13', 'resultsFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2019-02-13', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-20', 'studyFirstPostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Maximum Concentration of Kava in the Blood', 'timeFrame': 'pre-dose to 12 hours post-dose', 'description': 'Number of hours that it takes for kava metabolites to reach the maximum concentration in the blood based on multiple blood draws over a 12 hour period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['kava', 'dietary supplement', 'anxiety', 'generalized anxiety disorder (GAD)'], 'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'Kava is a dietary supplement on the US market and is experiencing a resurgence of its use. Its pharmacokinetic information, however, is lacking which is important for its future effective usage as a dietary supplement or potentially as a botanical therapeutics. This phased trial, based on the recommendation from NIH, is to collect pharmacokinetic data of kava in healthy subjects.', 'detailedDescription': "Kava is used in the South Pacific Islands for relaxation and socialization. It is available in the US as a dietary supplement, and was used in Europe in the 1990s to treat mild to moderate anxiety. Some clinical trials suggested kava's efficacy in treating generalized anxiety disorder (GAD), although a recent meta-analysis was inconclusive. While the mechanisms behind kava's anxiolytic activity are not well-established, its clinical use shows no signs of addiction or withdrawal. Kava thus is a promising and potentially novel anxiolytic with a unique mechanism of action. Although kava has been extensively consumed by humans for centuries, its pharmacokinetics have never been characterized in humans. Such knowledge is essential for its future studies of its anxiolytic potential and dose optimization. This study will characterize kava pharmacokinetics, which will set a solid foundation for its future clinical development. To establish kava pharmacokinetics, each participant will take three 75 mg kava capsules in a single dose and the absorption, distribution, metabolism and excretion of kava will be assessed, corresponding to the pharmacokinetic curve. Serum liver biochemistries will then be monitored for up to three months to test liver function response to kava."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide informed consent\n* Females of potential childbearing status must use adequate contraceptive precautions\n\nExclusion Criteria:\n\n* Currently taking any medication or supplement other than vitamins\n* Inability to refrain from acetaminophen, alcohol, or other potentially hepatotoxic substances during the study\n* Have a history of liver disease or currently have liver disease.\n* Elevation in serum ALT, AST, ALP or total bilirubin that reaches clinical significance (as determined by the PI) at screening.\n* Have an unstable medical, psychiatric, or neurological condition determined by history taken during the screening visit and a physical examination at the baseline visit.\n* Have a positive urine drug screen for substances of abuse.\n* Currently using tobacco or nicotine containing products of any form'}, 'identificationModule': {'nctId': 'NCT03843502', 'acronym': 'KavaPK', 'briefTitle': 'A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics', 'orgStudyIdInfo': {'id': 'IRB201900074 -N'}, 'secondaryIdInfos': [{'id': 'OCR20231', 'type': 'OTHER', 'domain': 'OnCore'}, {'id': '1R61AT009988-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R61AT009988-01A1', 'type': 'NIH'}, {'id': '3R61AT009988-02S1', 'link': 'https://reporter.nih.gov/quickSearch/3R61AT009988-02S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kava Pharmacokinetics Group', 'description': 'Each subject will take three 75 mg kava dietary supplement capsules in a single dose/timepoint and nine blood draws will be collected over an eight hour period following adminstration of kava.', 'interventionNames': ['Drug: Kava Dietary Supplement']}], 'interventions': [{'name': 'Kava Dietary Supplement', 'type': 'DRUG', 'otherNames': ['Kava metabolites'], 'description': 'Participants will be given three 75mg kava capsules.', 'armGroupLabels': ['Kava Pharmacokinetics Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF CTSI Clinical Research Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Carol Mathews, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}, {'name': 'Thorne HealthTech, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}