Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-08 @ 6:00 AM
Study NCT ID:
NCT02286934
Status:
COMPLETED
Last Update Posted:
2015-06-04
First Post:
2014-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077261', 'term': 'Carvedilol'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-02', 'studyFirstSubmitDate': '2014-09-05', 'studyFirstSubmitQcDate': '2014-11-07', 'lastUpdatePostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC (area under the plasma concentration-time curve) of carvedilol', 'timeFrame': 'predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose'}, {'measure': 'Cmax (Maximum plasma concentration) of carvedilol', 'timeFrame': 'predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carvedilol', 'CYP2D6', 'Isoproterenol Sensitivity Test'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29962926', 'type': 'DERIVED', 'citation': 'Jung E, Ryu S, Park Z, Lee JG, Yi JY, Seo DW, Lee J, Jeong HS, Kim JM, Oh WY. Influence of CYP2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamic Characteristics of Carvedilol in Healthy Korean Volunteers. J Korean Med Sci. 2018 May 23;33(27):e182. doi: 10.3346/jkms.2018.33.e182. eCollection 2018 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol', 'detailedDescription': 'This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;\n\nTo evaluate the change of the result of Isoproterenol Sensitivity Test according to Cytochrome P450 2D6 genotype after the multiple administration of carvedilol'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Subjects aged 20 - 45 years\n* A body mass index (BMI) in the range 18.0 kg/m2 (inclusive) - 27.0 kg/m2 (inclusive).\n* Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.\n\nExclusion Criteria:\n\n* Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Carvedilol, Isoproterenol).\n* Subject judged not eligible for study participation by investigator.'}, 'identificationModule': {'nctId': 'NCT02286934', 'briefTitle': 'Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Clinical Trial to Investigate the Influence of Cytochrome P450 2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamics Characteristics of Carvedilol in Healthy Korean Volunteers', 'orgStudyIdInfo': {'id': 'CYP-CVDL-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carvedilol', 'description': '* Day 1 to 3 : Carvedilol 12.5 mg qd\n* Day 4 to 8 : Carvedilol 25 mg qd\n* Day 9 to 11 : Carvedilol 12.5 mg qd\n\nIsoproterenol Sensitivity Test\n\n* Day 0, 1.5h post-dose Injection of isoproterenol 4 times (0.25, 0.5, 1, 2 ug/mL), time interval of 10 minutes.\n* Day 1, 8, 1.5h post-dose Injection of isoproterenol 4 times (5, 10, 20, 40 ug/mL), time interval of 10 minutes.\n\nMeasure change of heart rates after 1, 2, 3 minutes post injection of isoproterenol.', 'interventionNames': ['Drug: Carvedilol', 'Other: Isoproterenol Sensitivity Test']}], 'interventions': [{'name': 'Carvedilol', 'type': 'DRUG', 'description': '* Day 1 to 3 : Carvedilol 12.5 mg qd\n* Day 4 to 8 : Carvedilol 25 mg qd\n* Day 9 to 11 : Carvedilol 12.5 mg qd', 'armGroupLabels': ['Carvedilol']}, {'name': 'Isoproterenol Sensitivity Test', 'type': 'OTHER', 'description': 'Day 0, 1, 8 : Isoproterenol Sensitivity Test', 'armGroupLabels': ['Carvedilol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam', 'state': 'Gyounggi', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'overallOfficials': [{'name': 'Jae-Yong Chung, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Kore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Food and Drug Safety Evaluation, Korea', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jae Yong Chung', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}