Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-31 @ 12:19 AM
Study NCT ID:
NCT04486157
Status:
COMPLETED
Last Update Posted:
2021-06-01
First Post:
2020-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595957', 'term': 'netupitant, palosentron drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-28', 'studyFirstSubmitDate': '2020-07-17', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-t of netupitant', 'timeFrame': 'pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose', 'description': 'Area under the plasma concentration versus time curve of netupitant'}], 'secondaryOutcomes': [{'measure': 'Cmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron', 'timeFrame': 'pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose', 'description': 'Peak Plasma Concentration of fosnetupitant, netupitant metabolites and palonosetron'}, {'measure': 'tmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron', 'timeFrame': 'pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose', 'description': 'Time to reach maximum (peak) plasma concentration of fosnetupitant, netupitant, netupitant metabolites and palonosetron'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation', 'detailedDescription': '\\[Pharmacokinetics Assessment\\]\n\n* Primary Parameter\n\n \\- AUC0-t\n* Secondary Parameters - Cmax, tmax\n\n\\[Safety Assessment\\]\n\n\\- Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory tests'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adults aged between 19-45\n2. Body weight ≥ 50kg and in the range of ideal body weight ± 20%\n3. Without congenital, or chronic diseases within recent 5 years\n4. Subjects who are deemed eligible based on the screening tests\n5. Subjects who received a full explanation of the study, understood the purpose and details of this study, characteristics of the investigational product, and expected adverse events, and voluntarily signed the informed consent form\n6. Agree to use acceptable contraceptive methods from signing the informed consent to 3 weeks after the last dose of the investigational product\n7. Able and willing to comply with study requirements including all scheduled inpatient and outpatient visits, clinical laboratory tests, and instructions.\n\nExclusion Criteria:\n\n1. A subject with symptoms suspected of acute illness at the screening\n2. A subject with clinically significant and active cardiovascular, respiratory, kidney, endocrine, hematological, gastrointestinal, central nervous system diseases, psychiatric disorders, or malignant tumors\n3. A history of gastrointestinal disease\n4. Known hypersensitivity to the active ingredient or excipients of investigational product or a history of clinically significant hypersensitivity\n5. A history of drug abuse\n6. Pregnant women or women who may be pregnant, and breastfeeding women\n7. Subjects who are deemed inappropriate to participate in the study by the investigator for other reasons'}, 'identificationModule': {'nctId': 'NCT04486157', 'briefTitle': 'Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'HK inno.N Corporation'}, 'officialTitle': 'A Phase 1, Open Label, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Crossover Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects', 'orgStudyIdInfo': {'id': 'IN_FNP_101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IN-A012', 'description': 'Intravenous administration of IN-A012', 'interventionNames': ['Drug: IN-A012']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Akynzeo capsules', 'description': 'Single oral administration of Akynzeo capsules', 'interventionNames': ['Drug: Akynzeo 300Mg-0.5Mg Capsule']}], 'interventions': [{'name': 'IN-A012', 'type': 'DRUG', 'description': 'The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.', 'armGroupLabels': ['IN-A012']}, {'name': 'Akynzeo 300Mg-0.5Mg Capsule', 'type': 'DRUG', 'description': 'The subjects will be administrated Akynzeo by Orally with water.', 'armGroupLabels': ['Akynzeo capsules']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': "Catholic Univ. of Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seunghoon Han', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Catholic University of Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HK inno.N Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}