Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-01-07 @ 6:09 AM
Study NCT ID:
NCT03289234
Status:
COMPLETED
Last Update Posted:
2023-04-05
First Post:
2017-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
Sponsor:
Organization:
Raw JSON
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{'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatic Impairment', 'description': 'Child-Pugh score of 5 or 6'}, {'id': 'OG001', 'title': 'Moderate Hepatic Impairment', 'description': 'Child-Pugh score between 7 and 9'}, {'id': 'OG002', 'title': 'Normal Hepatic Function', 'description': 'normal hepatic function'}], 'classes': [{'categories': [{'measurements': [{'value': '538.1', 'spread': '182.3', 'groupId': 'OG000'}, {'value': '533.4', 'spread': '88.57', 'groupId': 'OG001'}, {'value': '429', 'spread': '44.36', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 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'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'AUC0-∞', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatic Impairment', 'description': 'Child-Pugh score of 5 or 6'}, {'id': 'OG001', 'title': 'Moderate Hepatic Impairment', 'description': 'Child-Pugh score between 7 and 9'}, {'id': 'OG002', 'title': 'Normal Hepatic Function', 'description': 'normal hepatic function'}], 'classes': [{'categories': [{'measurements': [{'value': '727.55', 'spread': '262.04', 'groupId': 'OG000'}, {'value': '751.52', 'spread': '148.34', 'groupId': 'OG001'}, {'value': '594.96', 'spread': '63.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 't½', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatic Impairment', 'description': 'Child-Pugh score of 5 or 6'}, {'id': 'OG001', 'title': 'Moderate Hepatic Impairment', 'description': 'Child-Pugh score between 7 and 9'}, {'id': 'OG002', 'title': 'Normal Hepatic Function', 'description': 'normal hepatic function'}], 'classes': [{'categories': [{'measurements': [{'value': '3.14', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '4.37', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '5.41', 'spread': '6.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mild Hepatic Impairment', 'description': 'Child-Pugh score of 5 or 6'}, {'id': 'FG001', 'title': 'Moderate Hepatic Impairment', 'description': 'Child-Pugh score between 7 and 9'}, {'id': 'FG002', 'title': 'Normal Hepatic Function', 'description': 'normal hepatic function'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Mild Hepatic Impairment', 'description': 'Child-Pugh score of 5 or 6'}, {'id': 'BG001', 'title': 'Moderate Hepatic Impairment', 'description': 'Child-Pugh score between 7 and 9'}, {'id': 'BG002', 'title': 'Normal Hepatic Function', 'description': 'normal hepatic function'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '66.2', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '2.7', 'groupId': 'BG002'}, {'value': '62.1', 'spread': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-02', 'size': 2868380, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-11-26T04:19', 'hasProtocol': True}, {'date': '2018-10-09', 'size': 862495, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-11-26T04:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-03', 'studyFirstSubmitDate': '2017-09-19', 'resultsFirstSubmitDate': '2020-02-13', 'studyFirstSubmitQcDate': '2017-09-19', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-13', 'studyFirstPostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose'}, {'measure': 'AUC0-last', 'timeFrame': 'pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose'}, {'measure': 'AUC0-∞', 'timeFrame': 'pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose'}], 'secondaryOutcomes': [{'measure': 't½', 'timeFrame': 'pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Impairment', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '32800532', 'type': 'DERIVED', 'citation': 'Nakamaru Y, Kakubari M, Yoshida K, Akimoto M, Todorovic V, Greis T, Kondo K. Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning. Clin Ther. 2020 Aug;42(8):1467-1482.e4. doi: 10.1016/j.clinthera.2020.06.016. Epub 2020 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects\n\n* Able to provide written informed consent to participate in this study after reading the ICF\n* Subjects is able to understand and willing to cooperate and comply with the Protocol restrictions and requirements.\n* A body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging from 18 to 30 kg/m2\n\nHepatic impaired subjects (in addition)\n\n* A Child-Pugh score of 5 or 6 for subjects with mild hepatic impairment, and between 7 and 9, inclusive, for subjects with moderate hepatic impairment\n* Chronic and stable hepatic impairment\n\nHealthy subjects (in addition)\n\n* Subject with normal hepatic function\n* Good health and free from clinically significant illness or disease\n\nExclusion Criteria:\n\nAll subjects\n\n* Presence or history of severe allergy to food, or any medicinal product or relevant excipient that is of clinical significance\n* Subjects were previously administered MCI-186.\n* Positive urine drug screen (if not due to concomitant medication) or alcohol test\n* History of drug abuse\n* Presence of alcohol abuse\n* Presence of active infection requiring antibiotics\n* Positive test for human immunodeficiency virus (HIV) antigen/antibody\n* Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)\\>160 mmHg and/or diastolic blood pressure (DBP)\\>100 mmHg\n* eGFR \\<60 mL/min/1.73m2\n\nHepatic impairment subject (in addition)\n\n* Subjects with severe ascites\n\nHealthy subject (in addition)\n\n* History or presence of any parenchymal hepatic disease\n* Positive test for hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCVAb)'}, 'identificationModule': {'nctId': 'NCT03289234', 'briefTitle': 'Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Multi-Center, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function', 'orgStudyIdInfo': {'id': 'MCI-186-J23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mild hepatic impairment', 'interventionNames': ['Drug: MCI-186']}, {'type': 'EXPERIMENTAL', 'label': 'moderate hepatic impairment', 'interventionNames': ['Drug: MCI-186']}, {'type': 'EXPERIMENTAL', 'label': 'normal hepatic function', 'interventionNames': ['Drug: MCI-186']}], 'interventions': [{'name': 'MCI-186', 'type': 'DRUG', 'otherNames': ['Edaravone', 'Radicut'], 'description': '30 mg of edaravone will be administered intravenously over 60 minutes', 'armGroupLabels': ['mild hepatic impairment', 'moderate hepatic impairment', 'normal hepatic function']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Investigational site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Investigational site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'General Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}