Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2026-01-13 @ 3:44 AM
Study NCT ID:
NCT06589635
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2024-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug-Drug Interaction (DDI) Study of ADC189 With Itraconazole in Healthy, Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2024-09-06', 'studyFirstSubmitQcDate': '2024-09-06', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC[0-∞] of ADC-189', 'timeFrame': 'Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40', 'description': 'Pharmacokinetics (PK) parameter: Area under the curve from time 0 hour to ∞'}, {'measure': 'Cmax of ADC-189', 'timeFrame': 'Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40', 'description': 'PK parameter: Maximum observed concentration'}, {'measure': 'AUC[0-t] of ADC-189', 'timeFrame': 'Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40', 'description': 'PK parameter: Area under the curve from time 0 to 336 hour'}, {'measure': 'Adverse events (AEs)', 'timeFrame': 'Day 1 to Day 43', 'description': 'Number of subjects reporting AEs'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adults']}, 'descriptionModule': {'briefSummary': 'This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of ADC189 in healthy adults.\n\nParticipants in this study will complete screening assessments within 14 days before the first dose of ADC189. Participants will be admitted to the clinical pharmacology center (CPC) and complete 2 periods of treatments. On Day 1 and 26, each participant will receive a single oral dose of ADC189 (45mg), under fasting condition On Day 22, all participants will receive oral doses of itraconazole 200 mg (bid), after meal. From Day 23 to Day 25, and Day 26-D39, participants will receive itraconazole 200 mg(qd). Blood and safety assessments will continue for 336-hours after dosing on Day 1 and Day 26. Participants will receive a telephone follow-up on D47 (±3) days for a final visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Sign informed consent, be capable of and willing to comply with study restrictions and procedures.\n* Healthy adult subjects aged 18 to 55 years.\n* Weight \\>=50kg for males, and \\>=45kg for females, BMI 19-26 kg/m\\^2.\n* No clinical significance in physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal ultrasound, and chest X-ray examination.\n\nExclusion Criteria:\n\n* Subjects who participated in other drug trials within 3 months before screening\n* Hospital admission or major surgery within 4 weeks prior to screening or a preplanned hospital admission during study participation\n* Donated or lost ≥400 mL of blood in the previous 3 months before screening\n* Have a history of allergic diseases (asthma, urticaria, eczema, etc.), or food allergies\n* A history of drug abuse in the past five years\n* Any condition or finding that in the Investigator's opinion would put the participant or study conduct at risk if the participant were to participate in the study\n* Unable to complete this study for other reasons or the Investigator believes that he or she should be excluded"}, 'identificationModule': {'nctId': 'NCT06589635', 'briefTitle': 'A Drug-Drug Interaction (DDI) Study of ADC189 With Itraconazole in Healthy, Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiaxing AnDiCon Biotech Co.,Ltd'}, 'officialTitle': 'A Single-center, Open-label and Sequential-dosing Clinical Trial Investigating the Drug Interaction Between ADC-189 Tablet and Itraconazole Capsule in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': '2023-ADC189-I-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADC-189 and itraconazole', 'description': 'Part 1: Single dose of ADC-189\n\nPart 2: Itraconazole with single dose of ADC-189', 'interventionNames': ['Drug: ADC-189 and Itraconazole']}], 'interventions': [{'name': 'ADC-189 and Itraconazole', 'type': 'DRUG', 'otherNames': ['Part 1: Single dose of ADC-189; Part 2: Itraconazole with single dose of ADC-189'], 'description': 'Part 1:\n\nDay 1, fasting condition, 45 mg ADC189, administered orally\n\nPart 2:\n\nDay 22, 200 mg itraconazole bid, taken orally after meals. Day 23-Day 25, 200 mg itraconazole was taken orally after meals. Day 26, 45 mg ADC-189 and 200 mg itraconazole was taken orally after meals. Day 27-Day 39, 200 mg itraconazole was taken orally after meals.', 'armGroupLabels': ['ADC-189 and itraconazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '233004', 'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affilicated Hospital of Bengbu Medical University', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}], 'overallOfficials': [{'name': 'Huan Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affilicated Hospital of Bengbu Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiaxing AnDiCon Biotech Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}