Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-03-28 @ 2:57 PM
Study NCT ID:
NCT06428903
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2024-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Bioavailability Study of Tablet and Granule Formulations of ADC189 and the Study of Ultra-high Dose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2024-05-19', 'studyFirstSubmitQcDate': '2024-05-22', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADC189 Granules', 'timeFrame': '15 days', 'description': 'ADC189 plasma exposure, area under the concentration-time curve'}, {'measure': 'ADC189 Tablet', 'timeFrame': '15 days', 'description': 'ADC189 plasma exposure, area under the concentration-time curve'}, {'measure': 'ADC189 Ultra high dose', 'timeFrame': '15 days', 'description': 'Single dose of 180mg ADC189 tablet plasma exposure, area under the concentration-time curve'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'Part 1 of this study will compare the pharmacokinetic performance of tablet and granule formulations of ADC189 under fasted conditions in healthy volunteers. A randomized, two-period, two-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation without food.\n\nThe purpose of Part 2 study is to determine the safety and pharmacokinetics of ultra high dose of ADC189 in healthy subjects.', 'detailedDescription': 'In Part 1 study, a total of 32 subjects were randomly divided into two groups, A and B, with 16 subjects in each group. After a 28-day screening period, on the first day of Period 1 (D1), subjects in group A took ADC189 granules (a single oral dose, 45mg), and subjects in group B took ADC189 tablets (a single oral dose, 45mg), all subjects were under fasted conditon. In Period 2, two groups will change to the fomulation which is different in Period 1 respectively, and all the steps will keep the same as Period 1. Each period lasts for 15 days, and have a 7-day interval between 2 periods. Blood samples will be taken, pharmacokinetic and saftey profiles will be observed.\n\nIn Part 2 study, the ultra high dose of ADC189 (a single oral dose, 180mg) will applied in 8 healty adult male subjects. The pharmacokinetic and saftey profiles will be observed during the following 15 days, and blood sample will be taken.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Healthy male subjects aged 18-45 years old\n* 2\\. Male subjects weight over 50 kg\n\nExclusion Criteria:\n\n* 1\\. Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions\n* 2\\. Have a history of drug abuse in the past five years or use drugs in the three months prior to screening\n* 3\\. Blood donation or blood loss \\> 400 mL in 3 months before screening'}, 'identificationModule': {'nctId': 'NCT06428903', 'briefTitle': 'Comparative Bioavailability Study of Tablet and Granule Formulations of ADC189 and the Study of Ultra-high Dose', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiaxing AnDiCon Biotech Co.,Ltd'}, 'officialTitle': 'A Comparison Study of ADC189 Bioavailability Between Tablet and Granule in Healthy Chinese Adult Male Subjects, and the Safety and Pharmacokinetics of Ultra-high Dose ADC189', 'orgStudyIdInfo': {'id': 'ADC-DNXV-189-GR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADC189 tablet Group A', 'description': '16 patients.', 'interventionNames': ['Drug: ADC189 tablet', 'Drug: ADC189 granules']}, {'type': 'EXPERIMENTAL', 'label': 'ADC189 granules Group B', 'description': '16 patients.', 'interventionNames': ['Drug: ADC189 tablet', 'Drug: ADC189 granules']}, {'type': 'EXPERIMENTAL', 'label': 'ADC189 180mg Group', 'description': '8 patients.', 'interventionNames': ['Drug: ADC189 180mg']}], 'interventions': [{'name': 'ADC189 tablet', 'type': 'DRUG', 'description': 'ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study)', 'armGroupLabels': ['ADC189 granules Group B', 'ADC189 tablet Group A']}, {'name': 'ADC189 granules', 'type': 'DRUG', 'description': 'ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study)', 'armGroupLabels': ['ADC189 granules Group B', 'ADC189 tablet Group A']}, {'name': 'ADC189 180mg', 'type': 'DRUG', 'description': 'ADC189 tablet, 180 mg, single oral dose. (Part 2 study)', 'armGroupLabels': ['ADC189 180mg Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250000', 'city': 'Jinan', 'state': 'Shang Dong', 'country': 'China', 'facility': 'Zhao Wei', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiaxing AnDiCon Biotech Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}