Viewing Study NCT04118127

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Ignite Creation Date: 2025-12-25 @ 5:08 AM
Ignite Modification Date: 2026-02-25 @ 12:56 AM
Study NCT ID: NCT04118127
Status: COMPLETED
Last Update Posted: 2024-08-05
First Post: 2019-10-04
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CL_OPCJ_RDA_Team@otsuka.jp', 'phone': '+81-3-6361-7366', 'title': 'Director of Clinical Trials', 'organization': 'Otsuka Pharmaceutical Co., LTD.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)', 'description': 'Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 Period 2', 'description': 'Subjects received a brexpiprazole QW formulation at 24 mg on Day 1. Subjects washed out brexpiprazole for 27 days until Period 3(Cohort 1).', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 21, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1 Period 3', 'description': 'Subjects received a brexpiprazole QW formulation at 48 mg on Day 1', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 11, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Cohort 2 Period 2', 'description': 'Subjects received a brexpiprazole QW formulation at 24 mg on Day 1. Subjects repeated administration of the QW formulation at 48 mg on Days 8, 15, 22, and 29.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 20, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 1 Period 1', 'description': 'Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Cohort 1 Period 2.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 16, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 2 Period 1', 'description': 'Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Cohort 2 Period 2.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 16, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Atrioventricular Block First Degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Hyperprolactinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Infected Dermal Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Ligament Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Skin Abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Blood Bilirubin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Blood Creatine Phosphokinase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Blood Glucose Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Blood Insulin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Blood Lactate Dehydrogenase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Blood Pressure Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Blood Pressure Systolic Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Blood Pressure Systolic Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Blood Prolactin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Platelet Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Urinary Occult Blood Positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Tooth Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Blood Cholesterol Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Blood Triglycerides Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Blood Uric Acid Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Musculoskeletal Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Vagus Nerve Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Scrotal Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Haemorrhage Subcutaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}, {'term': 'Dermatitis Atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}], 'seriousEvents': [{'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 23.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Tablet 2mg', 'description': 'Subjects received a brexpiprazole 2 mg conventional tablet on Day 1.'}, {'id': 'OG001', 'title': 'QW Formuration 24mg', 'description': 'Subjects received a brexpiprazole QW formulation at 24 mg on Day 1.'}, {'id': 'OG002', 'title': 'QW Formuration 48mg', 'description': 'Subjects received a brexpiprazole QW formulation at 48 mg on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '25.37', 'spread': '10.46', 'groupId': 'OG000'}, {'value': '98.62', 'spread': '46.76', 'groupId': 'OG001'}, {'value': '222.3', 'spread': '114.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose', 'description': 'To evaluate Cmax of OPC-34712 following single oral administration of the QW formulation (24 mg and 48 mg) and 2 mg conventional tablet .', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time to Maximum (Peak) Plasma Concentration (Tmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Tablet 2mg', 'description': 'Subjects received a brexpiprazole 2 mg conventional tablet on Day 1.'}, {'id': 'OG001', 'title': 'QW Formuration 24mg', 'description': 'Subjects received a brexpiprazole QW formulation at 24 mg on Day 1.'}, {'id': 'OG002', 'title': 'QW Formuration 48mg', 'description': 'Subjects received a brexpiprazole QW formulation at 48 mg on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '1.75', 'upperLimit': '24.37'}, {'value': '25.37', 'groupId': 'OG001', 'lowerLimit': '8.75', 'upperLimit': '49.50'}, {'value': '25.00', 'groupId': 'OG002', 'lowerLimit': '8.60', 'upperLimit': '46.42'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose', 'description': 'To evaluate Tmax of OPC-34712 following single oral administration of the QW formulation (24 mg and 48 mg) and 2 mg conventional tablet .', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Cmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QW Formuration 48mg', 'description': 'Subjects received a brexpiprazole QW formulation at 48 mg on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '225.0', 'spread': '147.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'prepose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours postdose', 'description': 'To evaluate Tmax of OPC-34712 following multiple oral administration of the QW formulation 48 mg.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QW Formuration 48mg', 'description': 'Subjects received a brexpiprazole QW formulation at 48 mg on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '24.61', 'groupId': 'OG000', 'lowerLimit': '8.50', 'upperLimit': '49.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'prepose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours postdose', 'description': 'To evaluate Tmax of OPC-34712 following multiple oral administration of the QW formulation 48 mg.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 2', 'description': 'Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Period 2(Cohort 2). Subjects received a brexpiprazole QW formulation at 24 mg on Day 1. Subjects repeated administration of the QW formulation at 48 mg on Days 8, 15, 22, and 29.'}, {'id': 'FG001', 'title': 'Cohort 1', 'description': 'Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Cohort 1 Period 2. Subjects received a brexpiprazole QW formulation at 24 mg on Day 1. Subjects washed out brexpiprazole for 27 days until Cohort 1 Period 3. Subjects received a brexpiprazole QW formulation at 48 mg on Day 1'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Trial terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The total number of subjects who participated in Cohort 1 and Cohort 2 was 73.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 Period 1', 'description': 'Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Cohort 1 Period 2.'}, {'id': 'BG001', 'title': 'Cohort 2 Period 1', 'description': 'Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Period 2(Cohort 2).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.8', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '47.1', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '46.9', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The total number of subjects who participated in Cohort 1 and Cohort 2 was 73. The total age average was calculated from 73 subjects in period 1 of Cohort 1 and Cohort 2.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-18', 'size': 1491606, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-24T20:52', 'hasProtocol': True}, {'date': '2021-03-31', 'size': 7329601, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-07-24T20:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2019-10-04', 'resultsFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2019-10-04', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-27', 'studyFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1', 'timeFrame': 'prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose', 'description': 'To evaluate Cmax of OPC-34712 following single oral administration of the QW formulation (24 mg and 48 mg) and 2 mg conventional tablet .'}, {'measure': 'Time to Maximum (Peak) Plasma Concentration (Tmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1', 'timeFrame': 'prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose', 'description': 'To evaluate Tmax of OPC-34712 following single oral administration of the QW formulation (24 mg and 48 mg) and 2 mg conventional tablet .'}, {'measure': 'Cmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2', 'timeFrame': 'prepose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours postdose', 'description': 'To evaluate Tmax of OPC-34712 following multiple oral administration of the QW formulation 48 mg.'}, {'measure': 'Tmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2', 'timeFrame': 'prepose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours postdose', 'description': 'To evaluate Tmax of OPC-34712 following multiple oral administration of the QW formulation 48 mg.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia,brexpiprazole,open-label,linical pharmacology'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'To evaluate the pharmacokinetics (PK), tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses in patients with schizophrenia.', 'detailedDescription': 'A multi-center, open-label clinical pharmacology trial to investigate the PK, tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses.\n\nThe trial comprises the single-dose period (Cohort 1) and the multiple-dose period (Cohort 2). The dose used in the multiple-dose period (Cohort 2) will be determined based on plasma drug concentrations obtained in the single-dose period (Cohort 1).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)\n2. Patients capable of staying at the trial site from the day before investigational medicinal product (IMP) administration to the 8th day following IMP administration in both Period 1 and Period 2\n3. Patients with a body mass index \\[BMI = body weight (kg)/height (m)2\\] of 18.5 or higher and lower than 35.0 at screening\n4. Persons who provide written informed consent before commencement of any trial-related procedures and whom the investigator or subinvestigator judges to be capable of following all the conditions of this trial\n5. Patients who, in the judgement of the investigator or subinvestigator, have stable psychotic symptoms maintained by administration of an antipsychotic (other than clozapine) within the dosing range indicated separately, before commencement of investigational medicinal product (IMP) administration"\n\nExclusion Criteria:\n\n1. Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (schizoaffective disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, personality disorder, etc) based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) (However, this exclusion does not apply to caffeine- or tobacco-related disorders)\n2. Patients who fail to meet the specified requisite washout periods for the prohibited concomitant drugs and foods before commencement of IMP administration, or patients who are anticipated to take any of these drugs or foods during the study period\n3. Patients who have previously undergone gastrointestinal surgery that could affect pharmacokinetic evaluations\n4. Patients who are using clozapine at the time of informed consent\n5. Patients who have received electro-convulsive therapy within 60 days before commencement of IMP administration\n6. Patients with clinically problematic disorders of the nervous system, liver, kidneys, metabolic system, blood, immune system, cardiovascular system, lungs, or digestive system (However, such patients may be included if the condition is mild or well-controlled and is considered to not affect safety or pharmacokinetic evaluations.)'}, 'identificationModule': {'nctId': 'NCT04118127', 'briefTitle': 'A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multi-center, Open-label Clinical Pharmacology Trial to Investigate the Pharmacokinetics, Tolerability, and Safety of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': '331-102-00150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2mg conventional tablet, once-weekly tablets', 'interventionNames': ['Drug: 2mg conventional tablet, once-weekly tablets']}], 'interventions': [{'name': '2mg conventional tablet, once-weekly tablets', 'type': 'DRUG', 'description': 'In each cohort, subjects will receive a brexpiprazole 2 mg conventional tablet on Day 1of Period 1, the QW formulation on Day 1 of Period 2 and 3, as single and multiple dose in a fasted state.', 'armGroupLabels': ['2mg conventional tablet, once-weekly tablets']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Sankeikai Nishigahara Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Takehisa Matsumaru', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Otsuka Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.', 'ipdSharing': 'YES', 'description': 'Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.', 'accessCriteria': 'Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}