Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-01-01 @ 11:23 PM
Study NCT ID:
NCT04481750
Status:
COMPLETED
Last Update Posted:
2024-08-02
First Post:
2020-07-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Oral Edaravone in Healthy Adult Males
Sponsor:
Organization:
Raw JSON
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male subjects receive a single dose of MT-1186 60 mg solution.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S3)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fasted condition in period 1, and fed condition in period 2 with washout period at least 4-day.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S4)', 'description': 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version 21.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 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6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 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'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)', 'description': 'Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG010', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG011', 'title': 'Matching Placebo (Multiple Doses Cohorts)', 'description': 'Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.'}], 'classes': [{'title': 'Participants with AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Participants with ADRs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to 8 in Part 1, up to 12 days in Part 2', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. 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A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration Versus Time Curve (AUC) of Sulfate Conjugate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'AUC from time zero to 24 hour (AUC 0-24): Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '16251', 'spread': '7143', 'groupId': 'OG000'}, {'value': '30004', 'spread': '6103', 'groupId': 'OG001'}, {'value': '45666', 'spread': '10447', 'groupId': 'OG002'}, {'value': '38244', 'spread': '4602', 'groupId': 'OG003'}, {'value': '67693', 'spread': '14170', 'groupId': 'OG004'}, {'value': '68126', 'spread': '15067', 'groupId': 'OG005'}, {'value': '6709', 'spread': '2171', 'groupId': 'OG006'}, {'value': '44797', 'spread': '16374', 'groupId': 'OG007'}, {'value': '26132', 'spread': '4083', 'groupId': 'OG008'}, {'value': '39516', 'spread': '3331', 'groupId': 'OG009'}]}]}, {'title': 'AUC from time zero to 24 hour (AUC 0-24): Day 5, only part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '24578', 'spread': '4186', 'groupId': 'OG008'}, {'value': '39102', 'spread': '4208', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; 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A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of Unchanged Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '755', 'spread': '356', 'groupId': 'OG000'}, {'value': '1735', 'spread': '738', 'groupId': 'OG001'}, {'value': '4933', 'spread': '1268', 'groupId': 'OG002'}, {'value': '899', 'spread': '464', 'groupId': 'OG003'}, {'value': '8805', 'spread': '933', 'groupId': 'OG004'}, {'value': '5426', 'spread': '2496', 'groupId': 'OG005'}, {'value': '208', 'spread': '112', 'groupId': 'OG006'}, {'value': '3692', 'spread': '1529', 'groupId': 'OG007'}, {'value': '1953', 'spread': '838', 'groupId': 'OG008'}, {'value': '3855', 'spread': '1676', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '2308', 'spread': '941', 'groupId': 'OG008'}, {'value': '4092', 'spread': '1715', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of Sulfate Conjugate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5481', 'spread': '2337', 'groupId': 'OG000'}, {'value': '9108', 'spread': '2104', 'groupId': 'OG001'}, {'value': '12190', 'spread': '2087', 'groupId': 'OG002'}, {'value': '7324', 'spread': '743', 'groupId': 'OG003'}, {'value': '14590', 'spread': '2102', 'groupId': 'OG004'}, {'value': '14080', 'spread': '4787', 'groupId': 'OG005'}, {'value': '2913', 'spread': '870', 'groupId': 'OG006'}, {'value': '11510', 'spread': '2502', 'groupId': 'OG007'}, {'value': '7318', 'spread': '612', 'groupId': 'OG008'}, {'value': '10830', 'spread': '2346', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '7402', 'spread': '954', 'groupId': 'OG008'}, {'value': '11200', 'spread': '1744', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of Glucuronide Conjugate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '1313', 'spread': '378', 'groupId': 'OG000'}, {'value': '2272', 'spread': '279', 'groupId': 'OG001'}, {'value': '3507', 'spread': '158', 'groupId': 'OG002'}, {'value': '1893', 'spread': '358', 'groupId': 'OG003'}, {'value': '5322', 'spread': '958', 'groupId': 'OG004'}, {'value': '3968', 'spread': '912', 'groupId': 'OG005'}, {'value': '750', 'spread': '263', 'groupId': 'OG006'}, {'value': '3361', 'spread': '1183', 'groupId': 'OG007'}, {'value': '2145', 'spread': '356', 'groupId': 'OG008'}, {'value': '3219', 'spread': '666', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '2209', 'spread': '156', 'groupId': 'OG008'}, {'value': '3439', 'spread': '428', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Part 2: Minimum Plasma Concentration at Steady State (Ctrough, ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG001', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Unchanged Edaravone', 'categories': [{'measurements': [{'value': '2.34', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '3.79', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Sulfate conjugate', 'categories': [{'measurements': [{'value': '32.91', 'spread': '9.01', 'groupId': 'OG000'}, {'value': '49.98', 'spread': '11.22', 'groupId': 'OG001'}]}]}, {'title': 'Glucuronide conjugate', 'categories': [{'measurements': [{'value': '2.69', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '5.48', 'spread': '1.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (S3-1 and S3-2 are crossover cohort, total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included a total of 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days.'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '1.6', 'groupId': 'OG003'}, {'value': '0.6', 'spread': '0.3', 'groupId': 'OG004'}, {'value': '0.8', 'spread': '0.4', 'groupId': 'OG005'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'OG006'}, {'value': '0.6', 'spread': '0.3', 'groupId': 'OG007'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'OG008'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.1', 'groupId': 'OG008'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax) of Sulfate Conjugate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '0.5', 'groupId': 'OG003'}, {'value': '1.3', 'spread': '0.3', 'groupId': 'OG004'}, {'value': '1.4', 'spread': '0.4', 'groupId': 'OG005'}, {'value': '0.5', 'spread': '0.3', 'groupId': 'OG006'}, {'value': '0.9', 'spread': '0.4', 'groupId': 'OG007'}, {'value': '0.8', 'spread': '0.3', 'groupId': 'OG008'}, {'value': '0.9', 'spread': '0.2', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.3', 'groupId': 'OG008'}, {'value': '0.8', 'spread': '0.3', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax) of Glucuronide Conjugate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '0.6', 'groupId': 'OG003'}, {'value': '1.0', 'spread': '0.3', 'groupId': 'OG004'}, {'value': '1.1', 'spread': '0.4', 'groupId': 'OG005'}, {'value': '0.5', 'spread': '0.3', 'groupId': 'OG006'}, {'value': '0.9', 'spread': '0.4', 'groupId': 'OG007'}, {'value': '0.7', 'spread': '0.3', 'groupId': 'OG008'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.2', 'groupId': 'OG008'}, {'value': '0.7', 'spread': '0.3', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Terminal Elimination Half-life (t1/2) of Unchanged Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '9.1', 'spread': '2.4', 'groupId': 'OG002'}, {'value': '5.2', 'spread': '1.7', 'groupId': 'OG003'}, {'value': '11.8', 'spread': '4.', 'groupId': 'OG004'}, {'value': '9.1', 'spread': '3.3', 'groupId': 'OG005'}, {'value': '2.4', 'spread': '0.7', 'groupId': 'OG006'}, {'value': '6.5', 'spread': '1.7', 'groupId': 'OG007'}, {'value': '4.6', 'spread': '0.4', 'groupId': 'OG008'}, {'value': '4.2', 'spread': '0.2', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '3.2', 'groupId': 'OG008'}, {'value': '12.4', 'spread': '1.9', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Terminal Elimination Half-life (t1/2) of Sulfate Conjugate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '6.0', 'spread': '1.6', 'groupId': 'OG004'}, {'value': '4.9', 'spread': '0.3', 'groupId': 'OG005'}, {'value': '5.2', 'spread': '0.6', 'groupId': 'OG006'}, {'value': '6.4', 'spread': '2.6', 'groupId': 'OG007'}, {'value': '3.7', 'spread': '0.2', 'groupId': 'OG008'}, {'value': '3.4', 'spread': '0.3', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '0.4', 'groupId': 'OG008'}, {'value': '6.8', 'spread': '1.0', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Terminal Elimination Half-life (t1/2) of Glucuronide Conjugate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '3.8', 'spread': '0.9', 'groupId': 'OG003'}, {'value': '5.9', 'spread': '1.4', 'groupId': 'OG004'}, {'value': '4.8', 'spread': '0.5', 'groupId': 'OG005'}, {'value': '2.8', 'spread': '0.9', 'groupId': 'OG006'}, {'value': '4.7', 'spread': '1.2', 'groupId': 'OG007'}, {'value': '3.5', 'spread': '0.2', 'groupId': 'OG008'}, {'value': '3.2', 'spread': '0.4', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.3', 'groupId': 'OG008'}, {'value': '5.2', 'spread': '2.0', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Lambda-z of Unchanged Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.02', 'groupId': 'OG002'}, {'value': '0.14', 'spread': '0.04', 'groupId': 'OG003'}, {'value': '0.07', 'spread': '0.02', 'groupId': 'OG004'}, {'value': '0.08', 'spread': '0.02', 'groupId': 'OG005'}, {'value': '0.31', 'spread': '0.11', 'groupId': 'OG006'}, {'value': '0.11', 'spread': '0.03', 'groupId': 'OG007'}, {'value': '0.15', 'spread': '0.01', 'groupId': 'OG008'}, {'value': '0.17', 'spread': '0.01', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.03', 'groupId': 'OG008'}, {'value': '0.06', 'spread': '0.01', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': '1/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Lambda-z of Sulfate Conjugate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '0.12', 'spread': '0.02', 'groupId': 'OG002'}, {'value': '0.14', 'spread': '0.03', 'groupId': 'OG003'}, {'value': '0.12', 'spread': '0.03', 'groupId': 'OG004'}, {'value': '0.14', 'spread': '0.01', 'groupId': 'OG005'}, {'value': '0.14', 'spread': '0.02', 'groupId': 'OG006'}, {'value': '0.12', 'spread': '0.03', 'groupId': 'OG007'}, {'value': '0.19', 'spread': '0.01', 'groupId': 'OG008'}, {'value': '0.20', 'spread': '0.02', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.01', 'groupId': 'OG008'}, {'value': '0.10', 'spread': '0.02', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': '1/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Lambda-z of Glucuronide Conjugate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '0.19', 'spread': '0.05', 'groupId': 'OG003'}, {'value': '0.12', 'spread': '0.02', 'groupId': 'OG004'}, {'value': '0.15', 'spread': '0.01', 'groupId': 'OG005'}, {'value': '0.27', 'spread': '0.07', 'groupId': 'OG006'}, {'value': '0.16', 'spread': '0.04', 'groupId': 'OG007'}, {'value': '0.20', 'spread': '0.01', 'groupId': 'OG008'}, {'value': '0.22', 'spread': '0.03', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.01', 'groupId': 'OG008'}, {'value': '0.15', 'spread': '0.05', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': '1/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Mean Residence Time (MRT) of Unchanged Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '1.92', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '1.98', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '3.41', 'spread': '0.62', 'groupId': 'OG003'}, {'value': '2.14', 'spread': '0.20', 'groupId': 'OG004'}, {'value': '2.42', 'spread': '0.45', 'groupId': 'OG005'}, {'value': '2.02', 'spread': '0.20', 'groupId': 'OG006'}, {'value': '2.02', 'spread': '0.32', 'groupId': 'OG007'}, {'value': '1.94', 'spread': '0.15', 'groupId': 'OG008'}, {'value': '1.90', 'spread': '0.26', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '2.17', 'spread': '0.24', 'groupId': 'OG008'}, {'value': '2.28', 'spread': '0.37', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Apparent Total Clearance (CL/F) of Unchanged Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension at 30 min before breakfast.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of matching placebo at 30 min before breakfast.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '79.77', 'spread': '26.21', 'groupId': 'OG000'}, {'value': '60.29', 'spread': '22.90', 'groupId': 'OG001'}, {'value': '32.73', 'spread': '6.42', 'groupId': 'OG002'}, {'value': '87.07', 'spread': '22.96', 'groupId': 'OG003'}, {'value': '26.42', 'spread': '2.30', 'groupId': 'OG004'}, {'value': '36.11', 'spread': '13.62', 'groupId': 'OG005'}, {'value': '119.41', 'spread': '43.64', 'groupId': 'OG006'}, {'value': '46.72', 'spread': '20.27', 'groupId': 'OG007'}, {'value': '64.51', 'spread': '11.64', 'groupId': 'OG008'}, {'value': '53.40', 'spread': '20.46', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '57.64', 'spread': '14.54', 'groupId': 'OG008'}, {'value': '50.74', 'spread': '18.08', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'PRIMARY', 'title': 'Apparent Distribution Volume at Elimination Phase (Vz/F) and Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.'}, {'id': 'OG003', 'title': 'A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day.'}, {'id': 'OG004', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG005', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG006', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG007', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.'}, {'id': 'OG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.'}, {'id': 'OG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.'}], 'classes': [{'title': 'Vz/F (Part 1), Vss/F (Part 2): Day1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '348.98', 'spread': '87.82', 'groupId': 'OG000'}, {'value': '422.67', 'spread': '126.97', 'groupId': 'OG001'}, {'value': '426.49', 'spread': '130.84', 'groupId': 'OG002'}, {'value': '620.73', 'spread': '139.24', 'groupId': 'OG003'}, {'value': '457.99', 'spread': '188.01', 'groupId': 'OG004'}, {'value': '457.37', 'spread': '175.69', 'groupId': 'OG005'}, {'value': '384.51', 'spread': '96.92', 'groupId': 'OG006'}, {'value': '408.95', 'spread': '121.29', 'groupId': 'OG007'}, {'value': '126.41', 'spread': '29.65', 'groupId': 'OG008'}, {'value': '105.90', 'spread': '57.04', 'groupId': 'OG009'}]}]}, {'title': 'Vss/F (only Part 2): Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '125.94', 'spread': '40.36', 'groupId': 'OG008'}, {'value': '121.32', 'spread': '66.83', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186).'}, {'type': 'SECONDARY', 'title': 'Change of Heart Rate (HR) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG003', 'title': 'Matching Placebo (a Sngle Dose Cohorts', 'description': 'Healthy Japanese male subjects receive a single dose of matching placebo.'}], 'classes': [{'title': '0.25h', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '0.96', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.92', 'groupId': 'OG003'}]}]}, {'title': '0.5h', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '1.02', 'groupId': 'OG003'}]}]}, {'title': '1h', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.34', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '1.29', 'groupId': 'OG003'}]}]}, {'title': '1.5h', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.04', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '1.01', 'groupId': 'OG003'}]}]}, {'title': '2h', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.99', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '0.96', 'groupId': 'OG003'}]}]}, {'title': '4h', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '1.42', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '1.37', 'groupId': 'OG003'}]}]}, {'title': '6h', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '1.87', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '1.96', 'groupId': 'OG002'}, {'value': '3.8', 'spread': '1.89', 'groupId': 'OG003'}]}]}, {'title': '8h', 'categories': [{'measurements': [{'value': '4.4', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.72', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '1.80', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '1.74', 'groupId': 'OG003'}]}]}, {'title': '12h', 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '2.07', 'groupId': 'OG001'}, {'value': '7.6', 'spread': '2.16', 'groupId': 'OG002'}, {'value': '4.6', 'spread': '2.09', 'groupId': 'OG003'}]}]}, {'title': '24h', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.54', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.61', 'groupId': 'OG002'}, {'value': '-1', 'spread': '1.55', 'groupId': 'OG003'}]}]}, {'title': '36h', 'categories': [{'measurements': [{'value': '8.1', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '3.06', 'groupId': 'OG001'}, {'value': '13.2', 'spread': '3.21', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '3.10', 'groupId': 'OG003'}]}]}, {'title': '48h', 'categories': [{'measurements': [{'value': '4.3', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '2.51', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '2.62', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '2.53', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.', 'description': 'Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose.', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic data were collected in Cohort S4, S5 and S6 with 18 (6x3 subjects receiving MT-1186), and 6 (2x3) receiving the placebo of Part 1.'}, {'type': 'SECONDARY', 'title': 'Change of PR Interval (PR) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG003', 'title': 'Matching Placebo (a Sngle Dose Cohorts', 'description': 'Healthy Japanese male subjects receive a single dose of matching placebo.'}], 'classes': [{'title': '0.25h', 'categories': [{'measurements': [{'value': '-6.8', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '1.99', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '1.92', 'groupId': 'OG002'}, {'value': '-4.5', 'spread': '2.06', 'groupId': 'OG003'}]}]}, {'title': '0.5h', 'categories': [{'measurements': [{'value': '-4.2', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '1.36', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '1.45', 'groupId': 'OG003'}]}]}, {'title': '1h', 'categories': [{'measurements': [{'value': '-4.2', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.74', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '1.68', 'groupId': 'OG002'}, {'value': '-4.7', 'spread': '1.80', 'groupId': 'OG003'}]}]}, {'title': '1.5h', 'categories': [{'measurements': [{'value': '-5.2', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.31', 'groupId': 'OG001'}, {'value': '-4.8', 'spread': '2.24', 'groupId': 'OG002'}, {'value': '-5.3', 'spread': '2.40', 'groupId': 'OG003'}]}]}, {'title': '2h', 'categories': [{'measurements': [{'value': '-5.9', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.97', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '1.91', 'groupId': 'OG002'}, {'value': '-5.9', 'spread': '2.05', 'groupId': 'OG003'}]}]}, {'title': '4h', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '2.74', 'groupId': 'OG001'}, {'value': '-5.3', 'spread': '2.66', 'groupId': 'OG002'}, {'value': '-5.4', 'spread': '2.85', 'groupId': 'OG003'}]}]}, {'title': '6h', 'categories': [{'measurements': [{'value': '-5.5', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '-9.6', 'spread': '1.98', 'groupId': 'OG001'}, {'value': '-6.3', 'spread': '1.92', 'groupId': 'OG002'}, {'value': '-6.6', 'spread': '2.06', 'groupId': 'OG003'}]}]}, {'title': '8h', 'categories': [{'measurements': [{'value': '-11.6', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '2.70', 'groupId': 'OG001'}, {'value': '-9.9', 'spread': '2.62', 'groupId': 'OG002'}, {'value': '-11.9', 'spread': '2.80', 'groupId': 'OG003'}]}]}, {'title': '12h', 'categories': [{'measurements': [{'value': '-6.6', 'spread': '3.91', 'groupId': 'OG000'}, {'value': '-12.0', 'spread': '4.06', 'groupId': 'OG001'}, {'value': '-9.0', 'spread': '3.93', 'groupId': 'OG002'}, {'value': '-11.8', 'spread': '4.21', 'groupId': 'OG003'}]}]}, {'title': '24h', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '2.72', 'groupId': 'OG001'}, {'value': '-8.9', 'spread': '2.63', 'groupId': 'OG002'}, {'value': '-1.1', 'spread': '2.82', 'groupId': 'OG003'}]}]}, {'title': '36h', 'categories': [{'measurements': [{'value': '-5.7', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '3.91', 'groupId': 'OG001'}, {'value': '-6.2', 'spread': '3.78', 'groupId': 'OG002'}, {'value': '-9.5', 'spread': '4.06', 'groupId': 'OG003'}]}]}, {'title': '48h', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.73', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '2.64', 'groupId': 'OG002'}, {'value': '-5.4', 'spread': '2.83', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.', 'description': 'Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose.', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic data were collected in Cohort S4, S5 and S6 with 18 (6x3 subjects receiving MT-1186), and 6 (2x3) receiving the placebo of Part 1.'}, {'type': 'SECONDARY', 'title': 'Change of QTcF Interval (QTcF) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG003', 'title': 'Matching Placebo (a Sngle Dose Cohorts', 'description': 'Healthy Japanese male subjects receive a single dose of matching placebo.'}], 'classes': [{'title': '0.25h', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.60', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.63', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '1.71', 'groupId': 'OG003'}]}]}, {'title': '0.5h', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '1.34', 'groupId': 'OG002'}, {'value': '-4.9', 'spread': '1.41', 'groupId': 'OG003'}]}]}, {'title': '1h', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.02', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '2.06', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '2.17', 'groupId': 'OG003'}]}]}, {'title': '1.5h', 'categories': [{'measurements': [{'value': '-5.2', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '1.71', 'groupId': 'OG002'}, {'value': '-5.3', 'spread': '2.40', 'groupId': 'OG003'}]}]}, {'title': '2h', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '2.34', 'groupId': 'OG001'}, {'value': '-5.1', 'spread': '2.39', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '1.80', 'groupId': 'OG003'}]}]}, {'title': '4h', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '2.85', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '2.90', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '3.06', 'groupId': 'OG003'}]}]}, {'title': '6h', 'categories': [{'measurements': [{'value': '-5.7', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '2.96', 'groupId': 'OG001'}, {'value': '-7.6', 'spread': '3.01', 'groupId': 'OG002'}, {'value': '-2.4', 'spread': '3.18', 'groupId': 'OG003'}]}]}, {'title': '8h', 'categories': [{'measurements': [{'value': '-5.3', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '2.62', 'groupId': 'OG001'}, {'value': '-7.0', 'spread': '2.66', 'groupId': 'OG002'}, {'value': '-6.9', 'spread': '2.81', 'groupId': 'OG003'}]}]}, {'title': '12h', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '2.42', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '2.47', 'groupId': 'OG002'}, {'value': '-3.3', 'spread': '2.6', 'groupId': 'OG003'}]}]}, {'title': '24h', 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '2.42', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '2.46', 'groupId': 'OG002'}, {'value': '-3.1', 'spread': '2.60', 'groupId': 'OG003'}]}]}, {'title': '36h', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '2.96', 'groupId': 'OG001'}, {'value': '-5.1', 'spread': '3.01', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '3.18', 'groupId': 'OG003'}]}]}, {'title': '48h', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '3.22', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '3.28', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '3.46', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.', 'description': 'Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose.', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic data were collected in Cohort S4, S5 and S6 with 18 (6x3 subjects receiving MT-1186), and 6 (2x3) receiving the placebo of Part 1.'}, {'type': 'SECONDARY', 'title': 'Change of QRS Duration (QRS) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.'}, {'id': 'OG001', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.'}, {'id': 'OG002', 'title': 'A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.'}, {'id': 'OG003', 'title': 'Matching Placebo (a Sngle Dose Cohorts', 'description': 'Healthy Japanese male subjects receive a single dose of matching placebo.'}], 'classes': [{'title': '0.25h', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.84', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.87', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '0.88', 'groupId': 'OG003'}]}]}, {'title': '0.5h', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.80', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '0.80', 'groupId': 'OG003'}]}]}, {'title': '1h', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '0.72', 'groupId': 'OG003'}]}]}, {'title': '1.5h', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.80', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.83', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '0.72', 'groupId': 'OG003'}]}]}, {'title': '2h', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.01', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '1.02', 'groupId': 'OG003'}]}]}, {'title': '4h', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '1.42', 'groupId': 'OG003'}]}]}, {'title': '6h', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '1.36', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '1.37', 'groupId': 'OG003'}]}]}, {'title': '8h', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.50', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '1.55', 'groupId': 'OG002'}, {'value': '-1.3', 'spread': '1.57', 'groupId': 'OG003'}]}]}, {'title': '12h', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '1.71', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '1.77', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '1.78', 'groupId': 'OG003'}]}]}, {'title': '24h', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '1.30', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '1.31', 'groupId': 'OG003'}]}]}, {'title': '36h', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.75', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '1.81', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '1.83', 'groupId': 'OG003'}]}]}, {'title': '48h', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '1.22', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '1.23', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.', 'description': 'Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6.', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic data were collected in Cohort S4, S5 and S6 with 18 (6x3 subjects receiving MT-1186), and 6 (2x3) receiving the placebo of Part 1.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution.'}, {'id': 'FG001', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension.'}, {'id': 'FG002', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S3)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fasted condition in period 1, and fed condition in period 2 with washout period at least 4-day.'}, {'id': 'FG003', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan.'}, {'id': 'FG004', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension.'}, {'id': 'FG005', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg suspension.'}, {'id': 'FG006', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension.'}, {'id': 'FG007', 'title': 'Matching Placebo (a Single Dose Cohorts)', 'description': 'Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.'}, {'id': 'FG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension.'}, {'id': 'FG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension.'}, {'id': 'FG010', 'title': 'Matching Placebo (Multiple Doses Cohorts)', 'description': 'Healthy Japanese male subjects receive multiple doses of matching placebo.'}], 'periods': [{'title': 'Period 1 (Fasted)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '14'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '14'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (After Meal)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'This cohort was closed in Period 1', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'This cohort was closed in Period 1', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Cohort S3 is a crossover study consisting of Period 1 (Cohort S3-1) and Period 2 (Cohort S3-2). Out of 6 subjects, only 5 subjects received MT-1186 in COhort S3-2.', 'groupId': 'FG002', 'numSubjects': '5'}, {'comment': 'This cohort was closed in Period 1', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'This cohort was closed in Period 1', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'This cohort was closed in Period 1', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'This cohort was closed in Period 1', 'groupId': 'FG006', 'numSubjects': '0'}, {'comment': 'This cohort was closed in Period 1', 'groupId': 'FG007', 'numSubjects': '0'}, {'comment': 'This cohort was closed in Period 1', 'groupId': 'FG008', 'numSubjects': '0'}, {'comment': 'This cohort was closed in Period 1', 'groupId': 'FG009', 'numSubjects': '0'}, {'comment': 'This cohort was closed in Period 1', 'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '74', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution.'}, {'id': 'BG001', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension.'}, {'id': 'BG002', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S3)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fasted condition in period 1, and fed condition in period 2 with washout period at least 4-day.'}, {'id': 'BG003', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan.'}, {'id': 'BG004', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension.'}, {'id': 'BG005', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 30 mg suspension.'}, {'id': 'BG006', 'title': 'A Single Dose MT-1186 (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension.'}, {'id': 'BG007', 'title': 'Matching Placebo (a Single Dose Cohorts)', 'description': 'Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.'}, {'id': 'BG008', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension.'}, {'id': 'BG009', 'title': 'Multiple Doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension.'}, {'id': 'BG010', 'title': 'Matching Placebo (Multiple Doses Cohorts)', 'description': 'Healthy Japanese male subjects receive multiple doses of matching placebo.'}, {'id': 'BG011', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '74', 'groupId': 'BG011'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '74', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '8', 'groupId': 'BG011'}]}]}, {'title': 'Asian (Japanese)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '66', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-02', 'size': 3359913, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-12T00:05', 'hasProtocol': True}, {'date': '2018-10-09', 'size': 3034726, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-12T00:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single Blind'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2020-07-17', 'resultsFirstSubmitDate': '2023-05-12', 'studyFirstSubmitQcDate': '2020-07-17', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-15', 'studyFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs)', 'timeFrame': 'Day 1 to 8 in Part 1, up to 12 days in Part 2'}, {'measure': 'Area Under the Concentration Versus Time Curve (AUC) of Unchanged Edaravone', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'description': 'Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of unchanged edaravone.'}, {'measure': 'Area Under the Concentration Versus Time Curve (AUC) of Sulfate Conjugate', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'description': 'Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of sulfate conjugate.'}, {'measure': 'Area Under the Concentration Versus Time Curve (AUC) of Glucuronide Conjugate', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5', 'description': 'Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of glucuronide conjugate.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Unchanged Edaravone', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Sulfate Conjugate', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Glucuronide Conjugate', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Part 2: Minimum Plasma Concentration at Steady State (Ctrough, ss)', 'timeFrame': 'Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) of Sulfate Conjugate', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) of Glucuronide Conjugate', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Terminal Elimination Half-life (t1/2) of Unchanged Edaravone', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Terminal Elimination Half-life (t1/2) of Sulfate Conjugate', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Terminal Elimination Half-life (t1/2) of Glucuronide Conjugate', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Lambda-z of Unchanged Edaravone', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Lambda-z of Sulfate Conjugate', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Lambda-z of Glucuronide Conjugate', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Mean Residence Time (MRT) of Unchanged Edaravone', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Apparent Total Clearance (CL/F) of Unchanged Edaravone', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}, {'measure': 'Apparent Distribution Volume at Elimination Phase (Vz/F) and Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone', 'timeFrame': 'Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5'}], 'secondaryOutcomes': [{'measure': 'Change of Heart Rate (HR) From Baseline', 'timeFrame': '0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.', 'description': 'Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose.'}, {'measure': 'Change of PR Interval (PR) From Baseline', 'timeFrame': '0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.', 'description': 'Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose.'}, {'measure': 'Change of QTcF Interval (QTcF) From Baseline', 'timeFrame': '0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.', 'description': 'Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose.'}, {'measure': 'Change of QRS Duration (QRS) From Baseline', 'timeFrame': '0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.', 'description': 'Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adult Subjects']}, 'referencesModule': {'references': [{'pmid': '33704925', 'type': 'RESULT', 'citation': 'Shimizu H, Nishimura Y, Shiide Y, Matsuda H, Akimoto M, Matsuda M, Nakamaru Y, Kato Y, Kondo K. Evaluation of Pharmacokinetics, Safety, and Drug-Drug Interactions of an Oral Suspension of Edaravone in Healthy Adults. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1174-1187. doi: 10.1002/cpdd.925. Epub 2021 Mar 11.'}, {'pmid': '36376130', 'type': 'DERIVED', 'citation': 'Shimizu H, Nishimura Y, Shiide Y, Akimoto M, Matsuda H, Kato Y, Hirai M. Food Effect Study to Assess the Impact on Edaravone Pharmacokinetic Profiles in Healthy Participants. Clin Ther. 2022 Dec;44(12):1552-1565. doi: 10.1016/j.clinthera.2022.10.001. Epub 2022 Nov 12.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of edaravone solution and suspension in healthy adult males'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdditional screening criteria check may apply for qualification:\n\n* Healthy adult male volunteers\n* Japanese or Caucasian\n* Subjects aged between 20 and 45 years at the time of informed consent\n* Subjects who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study\n\nExclusion Criteria:\n\nAdditional screening criteria check may apply for qualification:\n\n* 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\n* Body mass index (BMI) of \\<18.0 or \\>30.0, or body weight of \\<50 kg (BMI formula: body weight \\[kg\\]/height \\[m\\]2, rounded to one decimal place)\n* Subjects who have undergone any surgery known to affect the gastrointestinal absorption of drugs\n* Subjects who do not agree to use an effective method of contraception from initiation of study drug administration to 14 days after completion (discontinuation) of study drug administration\n* Subjects who have previously received edaravone\n* Subjects who have participated in another clinical study and received a study drug within 12 weeks before providing informed consent'}, 'identificationModule': {'nctId': 'NCT04481750', 'briefTitle': 'Study of Oral Edaravone in Healthy Adult Males', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'Phase I Study of Oral Edaravone in Healthy Adult Males (Single- and Multiple-dose Study)', 'orgStudyIdInfo': {'id': 'MT-1186-J01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A single dose MT-1186 (Part 1, Cohort S1)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.', 'interventionNames': ['Drug: MT-1186', 'Drug: MT-1186-matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'A single dose MT-1186 (Part 1, Cohort S2)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.', 'interventionNames': ['Drug: MT-1186', 'Drug: MT-1186-matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'A single dose MT-1186 (Part 1, Cohort S3-1)', 'description': 'Healthy Japanese male subjects receive doses of MT-1186 or matching placebo.', 'interventionNames': ['Drug: MT-1186', 'Drug: MT-1186-matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'A single dose MT-1186 (Part 1, Cohort S3-2)', 'description': 'Healthy Japanese male subjects receive doses of MT-1186 or matching placebo.', 'interventionNames': ['Drug: MT-1186', 'Drug: MT-1186-matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'A single dose MT-1186 (Part 1, Cohort S4)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.', 'interventionNames': ['Drug: MT-1186', 'Drug: MT-1186-matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'A single dose MT-1186 (Part 1, Cohort S5)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.', 'interventionNames': ['Drug: MT-1186', 'Drug: MT-1186-matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'A single dose MT-1186 (Part 1, Cohort S6)', 'description': 'Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.', 'interventionNames': ['Drug: MT-1186', 'Drug: MT-1186-matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'A single dose MT-1186 (Part 1, Cohort S7)', 'description': 'Healthy Caucasian male subjects receive a single dose of MT-1186 or matching placebo.', 'interventionNames': ['Drug: MT-1186', 'Drug: MT-1186-matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple doses MT-1186 (Part 2, Cohort M1)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo.', 'interventionNames': ['Drug: MT-1186', 'Drug: MT-1186-matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple doses MT-1186 (Part 2, Cohort M2)', 'description': 'Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo', 'interventionNames': ['Drug: MT-1186', 'Drug: MT-1186-matching placebo']}], 'interventions': [{'name': 'MT-1186', 'type': 'DRUG', 'otherNames': ['Edaravone'], 'description': 'Solution or suspension', 'armGroupLabels': ['A single dose MT-1186 (Part 1, Cohort S1)', 'A single dose MT-1186 (Part 1, Cohort S2)', 'A single dose MT-1186 (Part 1, Cohort S3-1)', 'A single dose MT-1186 (Part 1, Cohort S3-2)', 'A single dose MT-1186 (Part 1, Cohort S4)', 'A single dose MT-1186 (Part 1, Cohort S5)', 'A single dose MT-1186 (Part 1, Cohort S6)', 'A single dose MT-1186 (Part 1, Cohort S7)', 'Multiple doses MT-1186 (Part 2, Cohort M1)', 'Multiple doses MT-1186 (Part 2, Cohort M2)']}, {'name': 'MT-1186-matching placebo', 'type': 'DRUG', 'description': 'Solution or suspension', 'armGroupLabels': ['A single dose MT-1186 (Part 1, Cohort S1)', 'A single dose MT-1186 (Part 1, Cohort S2)', 'A single dose MT-1186 (Part 1, Cohort S3-1)', 'A single dose MT-1186 (Part 1, Cohort S3-2)', 'A single dose MT-1186 (Part 1, Cohort S4)', 'A single dose MT-1186 (Part 1, Cohort S5)', 'A single dose MT-1186 (Part 1, Cohort S6)', 'A single dose MT-1186 (Part 1, Cohort S7)', 'Multiple doses MT-1186 (Part 2, Cohort M1)', 'Multiple doses MT-1186 (Part 2, Cohort M2)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'country': 'Japan', 'facility': 'Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], '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'}}}}