Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-31 @ 5:05 PM
Study NCT ID:
NCT06619951
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2024-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}, {'id': 'D012293', 'term': 'Rifampin'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2024-09-28', 'studyFirstSubmitQcDate': '2024-09-28', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Day1-Day16', 'description': 'Maximum Observed Plasma Concentration (Cmax)'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）', 'timeFrame': 'Day1-Day16'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteers'], 'conditions': ['Locally Advanced or Metastatic Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This study will adopt a Single-center, Single-arm, Open, Fixed Sequence design to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions;\n* Able to complete the study in compliance with the protocol;\n* Subject (including partner) is willing to voluntarily take effective contraceptive measures from screening through 6 months after the last dose of study drug;\n* Male and female subjects between the ages of 18 and 45 years, inclusive;\n* At least 50.0kg for male subjects, 45.0kg for female subjects, with a Body Mass Index between 19.0-26.0 kg/m2, inclusive;\n\nExclusion Criteria:\n\n* More than 5 cigarettes per day on average within 3 months prior to screening;\n* with A history of allergies, including medications, foods, mites, etc., or those known to be potentially allergic to drugs similar to the study drug, or those known to be allergic to itraconazole, rifampicin, or any excipients;\n* History of drug and/or alcohol abuse (alcoholism defined as: drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); history of drug abuse or or have used drugs within the past five years;\n* Donation or loss of a significant volume of blood (\\>400 mL) within 3 months prior to screening;'}, 'identificationModule': {'nctId': 'NCT06619951', 'briefTitle': 'A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu vcare pharmaceutical technology co., LTD'}, 'officialTitle': 'A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'VC004-106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: VC004 and itraconazole', 'interventionNames': ['Drug: VC004 and Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: VC004 and rifampicin', 'interventionNames': ['Drug: VC004 and rifampicin']}], 'interventions': [{'name': 'VC004 and Itraconazole', 'type': 'DRUG', 'description': 'A single dose of VC004 was administered in the period 1. and a single dose of VC004 and Itraconazole coadministration in the period 2.', 'armGroupLabels': ['Group 1: VC004 and itraconazole']}, {'name': 'VC004 and rifampicin', 'type': 'DRUG', 'description': 'A single dose of VC004 was administered in the period 1. and a single dose of VC004 and rifampicin coadministration in the period 2.', 'armGroupLabels': ['Group 2: VC004 and rifampicin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda Hospital,Affiliated to Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Ling Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongda Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu vcare pharmaceutical technology co., LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}