Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-01 @ 4:17 PM
Study NCT ID:
NCT04776135
Status:
COMPLETED
Last Update Posted:
2024-01-08
First Post:
2021-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077553', 'term': 'Edaravone'}], 'ancestors': [{'id': 'D000983', 'term': 'Antipyrine'}, {'id': 'D047069', 'term': 'Pyrazolones'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cti-inq-ml@ml.mt-pharma.co.jp', 'phone': 'Please email', 'title': 'Clinical Trials, Information Desk', 'organization': 'Mitsubishi Tanabe Pharma Corporation'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The provision of informed consent to Day 11', 'description': 'This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.', 'eventGroups': [{'id': 'EG000', 'title': 'MT-1186 Orally', 'description': 'Healthy subjects were administered a single dose of Edaravone oral suspension (105 mg) orally under fasted condition.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 1, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MT-1186 Via NGT', 'description': 'Healthy subjects were administered a single dose of Edaravone oral suspension (105 mg) via NGT under fasted condition.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 3, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration Versus Time Curve (AUC) of Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MT-1186 Orally', 'description': 'Subjects receive the edaravone oral suspension orally.'}, {'id': 'OG001', 'title': 'MT-1186 Via NGT', 'description': 'Subjects receive the edaravone oral suspension via NGT'}], 'classes': [{'title': 'AUC0-t', 'categories': [{'measurements': [{'value': '2612', 'spread': '787', 'groupId': 'OG000'}, {'value': '2592', 'spread': '866', 'groupId': 'OG001'}]}]}, {'title': 'AUC0-inf', 'categories': [{'measurements': [{'value': '2657', 'spread': '801', 'groupId': 'OG000'}, {'value': '2617', 'spread': '870', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (NGT/oral)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.987', 'ciLowerLimit': '0.936', 'ciUpperLimit': '1.041', 'groupDescription': 'For AUC0-t, MT-1186 orally Versus MT-1186 via NGT', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'AUC0-t was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (NGT/oral)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.981', 'ciLowerLimit': '0.931', 'ciUpperLimit': '1.033', 'groupDescription': 'For AUC0-inf, MT-1186 orally Versus MT-1186 via NGT', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'AUC0-inf was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.'}], 'paramType': 'MEAN', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hours after administration.', 'description': 'Area under the plasma concentration versus time curve from time zero up to the last quantifiable concentration time-point (AUC0-t) of edaravone, and Area under the plasma concentration versus time curve from time zero up to infinity with extrapolation of the terminal phase (AUC0-inf) of edaravone.', 'unitOfMeasure': 'ng·h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MT-1186 Orally', 'description': 'Subjects receive the edaravone oral suspension orally.'}, {'id': 'OG001', 'title': 'MT-1186 Via NGT', 'description': 'Subjects receive the edaravone oral suspension via NGT'}], 'classes': [{'categories': [{'measurements': [{'value': '2470', 'spread': '839.8', 'groupId': 'OG000'}, {'value': '2775', 'spread': '1444', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (NGT/oral)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.052', 'ciLowerLimit': '0.903', 'ciUpperLimit': '1.227', 'groupDescription': 'MT-1186 orally Versus MT-1186 via NGT', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Cmax was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.'}], 'paramType': 'MEAN', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax) of Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MT-1186 Orally', 'description': 'Subjects receive the edaravone oral suspension orally.'}, {'id': 'OG001', 'title': 'MT-1186 Via NGT', 'description': 'Subjects receive the edaravone oral suspension via NGT'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '0.50'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.'}, {'type': 'PRIMARY', 'title': 'Terminal Elimination Half-life (t1/2) of Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MT-1186 Orally', 'description': 'Subjects receive the edaravone oral suspension orally.'}, {'id': 'OG001', 'title': 'MT-1186 Via NGT', 'description': 'Subjects receive the edaravone oral suspension via NGT'}], 'classes': [{'categories': [{'measurements': [{'value': '21.52', 'spread': '33.83', 'groupId': 'OG000'}, {'value': '13.53', 'spread': '13.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Elimination Rate Constant (Kel) of Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MT-1186 Orally', 'description': 'Subjects receive the edaravone oral suspension orally.'}, {'id': 'OG001', 'title': 'MT-1186 Via NGT', 'description': 'Subjects receive the edaravone oral suspension via NGT'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06430', 'spread': '0.03776', 'groupId': 'OG000'}, {'value': '0.07713', 'spread': '0.03269', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.', 'unitOfMeasure': '1/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.'}, {'type': 'PRIMARY', 'title': 'Mean Residence Time (MRT) of Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MT-1186 Orally', 'description': 'Subjects receive the edaravone oral suspension orally.'}, {'id': 'OG001', 'title': 'MT-1186 Via NGT', 'description': 'Subjects receive the edaravone oral suspension via NGT'}], 'classes': [{'categories': [{'measurements': [{'value': '4.66', 'spread': '8.89', 'groupId': 'OG000'}, {'value': '2.89', 'spread': '1.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.'}, {'type': 'PRIMARY', 'title': 'Apparent Total Clearance (CL/F) of Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MT-1186 Orally', 'description': 'Subjects receive the edaravone oral suspension orally.'}, {'id': 'OG001', 'title': 'MT-1186 Via NGT', 'description': 'Subjects receive the edaravone oral suspension via NGT'}], 'classes': [{'categories': [{'measurements': [{'value': '42.8', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '43.8', 'spread': '12.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.'}, {'type': 'PRIMARY', 'title': 'Apparent Distribution Volume at Elimination Phase (Vz/F) of Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MT-1186 Orally', 'description': 'Subjects receive the edaravone oral suspension orally.'}, {'id': 'OG001', 'title': 'MT-1186 Via NGT', 'description': 'Subjects receive the edaravone oral suspension via NGT'}], 'classes': [{'categories': [{'measurements': [{'value': '1209', 'spread': '1682', 'groupId': 'OG000'}, {'value': '816', 'spread': '782', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.'}, {'type': 'PRIMARY', 'title': 'Apparent Distribution Volume at Steady State (Vss/F) of Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MT-1186 Orally', 'description': 'Subjects receive the edaravone oral suspension orally.'}, {'id': 'OG001', 'title': 'MT-1186 Via NGT', 'description': 'Subjects receive the edaravone oral suspension via NGT'}], 'classes': [{'categories': [{'measurements': [{'value': '183.7', 'spread': '299.9', 'groupId': 'OG000'}, {'value': '125.4', 'spread': '67.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events and Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MT-1186 Orally', 'description': 'Subjects receive the edaravone oral suspension orally.'}, {'id': 'OG001', 'title': 'MT-1186 Via NGT', 'description': 'Subjects receive the edaravone oral suspension via NGT'}], 'classes': [{'title': 'Number of Participants with Adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Number of Participants with adverse drug reactions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to 11', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MT-1186 Orally, Then MT-1186 Via a Nasogastric Tube (NGT)', 'description': 'Period 1: a single dose of Edaravone oral suspension orally. Period 2: a single dose of Edaravone oral suspension via a NGT.'}, {'id': 'FG001', 'title': 'MT-1186 Via NGT, Then MT-1186 Orally', 'description': 'Period 1: a single dose of Edaravone oral suspension via NGT. Period 2 : a single dose of Edaravone oral suspension orally.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MT-1186 Orally, Then MT-1186 Via a Nasogastric Tube (NGT)', 'description': 'Period 1: a single dose of Edaravone oral suspension orally. Period 2: a single dose of Edaravone oral suspension via a NGT.'}, {'id': 'BG001', 'title': 'MT-1186 Via NGT, Then MT-1186 Orally', 'description': 'Period 1: a single dose of Edaravone oral suspension via NGT. Period 2 : a single dose of Edaravone oral suspension orally.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-12', 'size': 2690286, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-17T05:58', 'hasProtocol': True}, {'date': '2021-06-22', 'size': 872182, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-17T05:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2021-02-25', 'resultsFirstSubmitDate': '2023-03-17', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-05', 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration Versus Time Curve (AUC) of Edaravone', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hours after administration.', 'description': 'Area under the plasma concentration versus time curve from time zero up to the last quantifiable concentration time-point (AUC0-t) of edaravone, and Area under the plasma concentration versus time curve from time zero up to infinity with extrapolation of the terminal phase (AUC0-inf) of edaravone.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Edaravone', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) of Edaravone', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.'}, {'measure': 'Terminal Elimination Half-life (t1/2) of Edaravone', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.'}, {'measure': 'Apparent Terminal Elimination Rate Constant (Kel) of Edaravone', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.'}, {'measure': 'Mean Residence Time (MRT) of Edaravone', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.'}, {'measure': 'Apparent Total Clearance (CL/F) of Edaravone', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.'}, {'measure': 'Apparent Distribution Volume at Elimination Phase (Vz/F) of Edaravone', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.'}, {'measure': 'Apparent Distribution Volume at Steady State (Vss/F) of Edaravone', 'timeFrame': 'Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events and Adverse Drug Reactions', 'timeFrame': 'Day 1 to 11'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adult Subjects']}, 'referencesModule': {'references': [{'pmid': '36225132', 'type': 'RESULT', 'citation': 'Shimizu H, Nishimura Y, Shiide Y, Ueda M, Yokota S, Kato Y, Hirai M. Edaravone Administered Orally and Via Nasogastric Tube in Healthy Adults: A Comparative Bioavailability Phase 1 Study. Clin Pharmacol Drug Dev. 2023 Jan;12(1):77-84. doi: 10.1002/cpdd.1175. Epub 2022 Oct 12.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the comparative bioavailability of edaravone oral suspension administered orally and via a nasogastric tube in healthy adult subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Subjects who meet all of the following criteria and who have the capability of giving informed consent will be included in the study.\n\n1. Healthy adult male or female volunteers\n2. Japanese\n3. Subjects aged between 20 and 45 years at the time of informed consent\n4. Subjects who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study\n\nExclusion Criteria: Subjects who meet any of the following criteria between screening and investigational product administration will be excluded from the study.\n\n1. Subjects with a current or previous history of cardiac, hepatic, renal, gastrointestinal, respiratory, psychiatric/nervous, hematopoietic, or endocrine diseases, and those whom the investigator (or subinvestigator) deems unsuitable for the study\n2. History of drug or food allergies\n3. History of alcohol or drug abuse or dependence\n4. Body mass index (BMI) of \\<18.0 or \\>30.0, or a body weight of \\<50 kg (BMI formula: body weight \\[kg\\]/height \\[m\\]2, rounded to one decimal place)\n5. Positive test for any of the following at screening: Hepatitis B surface antigen, serological test for syphilis, hepatitis C virus antibody, or human immunodeficiency virus antigen/antibody, subject has a positive COVID-19 virus test on Day -1\n6. Any clinically significant 12-lead ECG abnormality or QTcF interval ≥450 msec\n7. Blood donation or sampling with a total volume of ≥400 mL within 12 weeks, ≥200 mL within 4 weeks, or ≥800 mL within one year before providing informed consent\n8. Blood component donation or blood sampling within 2 weeks before providing informed consent, or blood donation and transfusion from informed consent to the start of investigational product administration\n9. Subjects who have undergone any surgery known to affect the gastrointestinal absorption of drugs (except for appendectomy and herniotomy)\n10. Female subjects of childbearing potential who do not agree to use an effective method of contraception from screening or 2 weeks before the start of investigational product administration, whichever comes earlier, to 14 days after the completion (or discontinuation) of investigational product administration. Male subjects who do not agree to use an effective method of contraception from the start of investigational product administration to 14 days after the completion (or discontinuation) of investigational product administration\n11. Subjects who have previously received edaravone\n12. Subjects who have participated in another clinical study and received an investigational product within 12 weeks before providing informed consent\n13. Subjects who have used any drugs other than the single use of acetylsalicylic acid within 7 days before the initiation of investigational product administration\n14. Use of alcohol or any products containing xanthin or caffeine within 24 hours before screening and visit on Day -1\n15. Use of any nutritional supplement(s) within 7 days before the initiation of investigational product administration\n16. Use of grapefruit, grapefruit juice, or any processed food(s) containing these substances within 24 hours before screening and visit on Day -1\n17. Use of any tobacco or nicotine-containing product(s) within 24 hours before screening and visit on Day -1\n18. Female subjects who have a positive pregnancy test at screening and on Day -1, are pregnant or breast feeding, or plan to get pregnant during the study\n19. Subjects with a history of reconstructive nasal surgery, or any evidence of deformities or asymmetry of the nose, non-patent nares/obstructed nasal airway, or the presence of nasal ulcers or polyps that would prevent an adequate NGT insertion.\n20. Subjects judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason'}, 'identificationModule': {'nctId': 'NCT04776135', 'briefTitle': 'Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Phase I, Randomized, Open-Label, Crossover-Design, Single-Dose Study to Investigate the Safety, Tolerability and Comparative Bioavailability of Oral Edaravone Administered Orally and Via a Nasogastric Tube (NGT) in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'MT-1186-Z-101'}, 'secondaryIdInfos': [{'id': 'jRCT2031200361', 'type': 'REGISTRY', 'domain': 'Japan Registry of Clinical Trials (jRCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MT-1186 orally', 'description': 'Subjects receive the edaravone oral suspension orally.', 'interventionNames': ['Drug: MT-1186']}, {'type': 'EXPERIMENTAL', 'label': 'MT-1186 via a nasogastric tube', 'description': 'Subjects receive the edaravone oral suspension via a nasogastric tube', 'interventionNames': ['Drug: MT-1186']}], 'interventions': [{'name': 'MT-1186', 'type': 'DRUG', 'otherNames': ['Edaravone'], 'description': 'Suspension', 'armGroupLabels': ['MT-1186 orally', 'MT-1186 via a nasogastric tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '171-0014', 'city': 'Tokyo', 'state': 'Toshima-ku', 'country': 'Japan', 'facility': 'Investigational site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'General Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}