Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-02 @ 12:56 AM
Study NCT ID:
NCT01080651
Status:
COMPLETED
Last Update Posted:
2011-08-19
First Post:
2010-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Drug-drug Interactions on the Pharmacokinetics (PK) of Voriconazole
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D065819', 'term': 'Voriconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-17', 'studyFirstSubmitDate': '2010-03-02', 'studyFirstSubmitQcDate': '2010-03-02', 'lastUpdatePostDateStruct': {'date': '2011-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration of voriconazole', 'timeFrame': 'pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h post-dose', 'description': 'Sample for concentration measurement conducted before and after rifampicin treatment as same manner'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Invasive Aspergillosis']}, 'descriptionModule': {'briefSummary': 'To evaluate the drug-drug interaction between rifampicin and voriconazole according to CYP2C19 genotype quantitatively following a single oral administration of 200 mg voriconazole'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Healthy male subjects aged 20 - 50 years.\n* 2.A body mass index (BMI) in the range 17-28 kg/m2.\n* 3.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* 1.Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.\n* 2.Clinically relevant abnormal medical history that could interfere with the objectives of the study.\n* 3.Presence or history of eye disease or eye field defect.\n* 4.A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.\n* 5.A subject whose liver function test (AST, ALT, GGT, ALP, LDH) result is over 1.25 times of upper limit of normal range.\n* 6.A subject whose SBP is over 140 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.\n* 7.Presence or history of drug abuse.\n* 8.Participation in other clinical trial within 2 months.\n* 9.Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose.\n* 10.Blood donation during 2 months or apheresis during 1 month before the study.\n* 11.Presence or history of alcohol abuse.\n* 12.Smoking of more than 10 cigarettes/day.\n* 13.Use of grapefruit juice, xanthine containing beverage, alcohol or smoking during restriction period.\n* 14.Subject judged not eligible for study participation by investigator.'}, 'identificationModule': {'nctId': 'NCT01080651', 'briefTitle': 'Influence of Drug-drug Interactions on the Pharmacokinetics (PK) of Voriconazole', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Clinical Trials to Evaluate the Influence of CYP2C19 Genotype and Drug-drug Interactions on the Pharmacokinetics of Voriconazole in Healthy Korean Male Volunteers (Part B)', 'orgStudyIdInfo': {'id': 'SNUCPT09_Vori2C19_B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CYP2C19 extensive metabolizer', 'interventionNames': ['Drug: Voriconazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CYP2C19 poor metabolizer', 'interventionNames': ['Drug: Voriconazole']}], 'interventions': [{'name': 'Voriconazole', 'type': 'DRUG', 'description': 'Day1: voriconazole 200 mg x 2, oral administration, Day2-7: rifampin 600 mg, once a day oral administration, Day8: voriconazole 200 mg x 2 + rifampin 600 mg, oral co-administration', 'armGroupLabels': ['CYP2C19 extensive metabolizer', 'CYP2C19 poor metabolizer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital Clinical Trial Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'In-Jin Jang, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'In-Jin Jang', 'oldOrganization': 'Seoul National University Hospital'}}}}