Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-03-03 @ 3:01 PM
Study NCT ID:
NCT03228433
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2017-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723826', 'term': 'TAK-418'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion .", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohorts 1-5: Placebo', 'description': 'TAK-418 placebo-matching, capsule, orally, once on Day 1.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1: TAK-418 5 mg', 'description': 'TAK-418 5 mg, capsule, orally, once on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2: TAK-418 15 mg', 'description': 'TAK-418 15 mg, capsule, orally, once on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 3A: TAK-418 30 mg Fasted', 'description': 'TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 3B: TAK-418 30 mg Fed', 'description': 'TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 4: TAK-418 40 mg', 'description': 'TAK-418 40 mg, capsule, orally, once on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Cohort 5: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Limb discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-5: Placebo', 'description': 'TAK-418 placebo-matching, capsule, orally, once on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: TAK-418 5 mg', 'description': 'TAK-418 5 mg, capsule, orally, once on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2: TAK-418 15 mg', 'description': 'TAK-418 15 mg, capsule, orally, once on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3A: TAK-418 30 mg Fasted', 'description': 'TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 3B: TAK-418 30 mg Fed', 'description': 'TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 4: TAK-418 40 mg', 'description': 'TAK-418 40 mg, capsule, orally, once on Day 1.'}, {'id': 'OG006', 'title': 'Cohort 5: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up to Day 184', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Due to an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-5: Placebo', 'description': 'TAK-418 placebo-matching, capsule, orally, once on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: TAK-418 5 mg', 'description': 'TAK-418 5 mg, capsule, orally, once on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2: TAK-418 15 mg', 'description': 'TAK-418 15 mg, capsule, orally, once on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3A: TAK-418 30 mg Fasted', 'description': 'TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 3B: TAK-418 30 mg Fed', 'description': 'TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 4: TAK-418 40 mg', 'description': 'TAK-418 40 mg, capsule, orally, once on Day 1.'}, {'id': 'OG006', 'title': 'Cohort 5: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once on Day 1.'}], 'classes': [{'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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up to Day 184', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Meet the Markedly Abnormal Criteria for Neurological Assessment Measurements at Least Once Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-5: Placebo', 'description': 'TAK-418 placebo-matching, capsule, orally, once on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: TAK-418 5 mg', 'description': 'TAK-418 5 mg, capsule, orally, once on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2: TAK-418 15 mg', 'description': 'TAK-418 15 mg, capsule, orally, once on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3A: TAK-418 30 mg Fasted', 'description': 'TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 3B: TAK-418 30 mg Fed', 'description': 'TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 4: TAK-418 40 mg', 'description': 'TAK-418 40 mg, capsule, orally, once on Day 1.'}, {'id': 'OG006', 'title': 'Cohort 5: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once on Day 1.'}], 'classes': [{'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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up to Day 184', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-5: Placebo', 'description': 'TAK-418 placebo-matching, capsule, orally, once on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: TAK-418 5 mg', 'description': 'TAK-418 5 mg, capsule, orally, once on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2: TAK-418 15 mg', 'description': 'TAK-418 15 mg, capsule, orally, once on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3A: TAK-418 30 mg Fasted', 'description': 'TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 3B: TAK-418 30 mg Fed', 'description': 'TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 4: TAK-418 40 mg', 'description': 'TAK-418 40 mg, capsule, orally, once on Day 1.'}, {'id': 'OG006', 'title': 'Cohort 5: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once on Day 1.'}], 'classes': [{'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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up to Day 184', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-5: Placebo', 'description': 'TAK-418 placebo-matching, capsule, orally, once on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: TAK-418 5 mg', 'description': 'TAK-418 5 mg, capsule, orally, once on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2: TAK-418 15 mg', 'description': 'TAK-418 15 mg, capsule, orally, once on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3A: TAK-418 30 mg Fasted', 'description': 'TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 3B: TAK-418 30 mg Fed', 'description': 'TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 4: TAK-418 40 mg', 'description': 'TAK-418 40 mg, capsule, orally, once on Day 1.'}, {'id': 'OG006', 'title': 'Cohort 5: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once on Day 1.'}], 'classes': [{'title': 'Diastolic blood pressure less than (<) 50 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Systolic blood pressure < 85 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Temperature < 35.6 degrees celsius (°C)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Temperature greater than (>) 37.7 (°C)', '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': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up to day 184', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-5: Placebo', 'description': 'TAK-418 placebo-matching, capsule, orally, once on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: TAK-418 5 mg', 'description': 'TAK-418 5 mg, capsule, orally, once on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2: TAK-418 15 mg', 'description': 'TAK-418 15 mg, capsule, orally, once on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3A: TAK-418 30 mg Fasted', 'description': 'TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 3B: TAK-418 30 mg Fed', 'description': 'TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 4: TAK-418 40 mg', 'description': 'TAK-418 40 mg, capsule, orally, once on Day 1.'}, {'id': 'OG006', 'title': 'Cohort 5: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once on Day 1.'}], 'classes': [{'title': 'ECG ventricular rate(Beats/ minute)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'QT interval (Milliseconds)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up to Day 14', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-418F (TAK-418 Free Base)', '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'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TAK-418 5 mg', 'description': 'TAK-418 5 mg, capsule, orally, once on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: TAK-418 15 mg', 'description': 'TAK-418 15 mg, capsule, orally, once on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3A: TAK-418 30 mg Fasted', 'description': 'TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3B: TAK-418 30 mg Fed', 'description': 'TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 4: TAK-418 40 mg', 'description': 'TAK-418 40 mg, capsule, orally, once on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 5: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.3', 'spread': '47.1', 'groupId': 'OG000'}, {'value': '290.4', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '649.4', 'spread': '8.5', 'groupId': 'OG002'}, {'value': '616.2', 'spread': '23.1', 'groupId': 'OG003'}, {'value': '674.1', 'spread': '27.0', 'groupId': 'OG004'}, {'value': '1576.3', 'spread': '33.5', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.951', 'ciLowerLimit': '0.823', 'ciUpperLimit': '1.099', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A linear mixed effect model on the natural log-transformed parameters was performed with a fixed effect for regimen and random effect for participant. The least squares(LS) means and difference of least squares (LS) means for the log-transformed parameters were exponentiated to obtain the point estimates (Geometric LS means) of the food effect and 90% confidence intervals (CIs).'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG004', 'OG005'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.14', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.25', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A linear regression model (power model), log (ln) (parameter) equal to (=) intercept plus (+) slope\\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln(0.8) per (/)l n(r) to 1 + ln(1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose', 'unitOfMeasure': 'hour nanogram per milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.'}, {'type': 'SECONDARY', 'title': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418F', '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'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TAK-418 5 mg', 'description': 'TAK-418 5 mg, capsule, orally, once on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: TAK-418 15 mg', 'description': 'TAK-418 15 mg, capsule, orally, once on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3A: TAK-418 30 mg Fasted', 'description': 'TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3B: TAK-418 30 mg Fed', 'description': 'TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 4: TAK-418 40 mg', 'description': 'TAK-418 40 mg, capsule, orally, once on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 5: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.9', 'spread': '47.4', 'groupId': 'OG000'}, {'value': '296.3', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '659.6', 'spread': '8.0', 'groupId': 'OG002'}, {'value': '626.0', 'spread': '22.7', 'groupId': 'OG003'}, {'value': '681.0', 'spread': '26.9', 'groupId': 'OG004'}, {'value': '1519.9', 'spread': '33.3', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.951', 'ciLowerLimit': '0.825', 'ciUpperLimit': '1.097', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence interval of 627.51 to 659.59'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG004', 'OG005'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.11', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.22', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A linear regression model (power model), ln (parameter) = intercept + slope\\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln (0.8)/l n(r) to 1 + ln (1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for TAK-418F', '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'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TAK-418 5 mg', 'description': 'TAK-418 5 mg, capsule, orally, once on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: TAK-418 15 mg', 'description': 'TAK-418 15 mg, capsule, orally, once on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3A: TAK-418 30 mg Fasted', 'description': 'TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3B: TAK-418 30 mg Fed', 'description': 'TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 4: TAK-418 40 mg', 'description': 'TAK-418 40 mg, capsule, orally, once on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 5: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.54', 'spread': '35.9', 'groupId': 'OG000'}, {'value': '61.90', 'spread': '26.6', 'groupId': 'OG001'}, {'value': '163.64', 'spread': '20.9', 'groupId': 'OG002'}, {'value': '94.93', 'spread': '33.8', 'groupId': 'OG003'}, {'value': '155.32', 'spread': '34.3', 'groupId': 'OG004'}, {'value': '321.52', 'spread': '14.1', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.580', 'ciLowerLimit': '0.431', 'ciUpperLimit': '0.781', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A linear mixed effect model on the natural log-transformed parameters was performed with a fixed effect for regimen and random effect for participant. The LS means and difference of LS means for the log-transformed parameters were exponentiated to obtain the point estimates (Geometric LS means) of the food effect and 90% confidence intervals CIs.'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG004', 'OG005'], 'paramType': 'Slope', 'ciPctValue': '90', 'paramValue': '1.06', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.17', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A linear regression model (power model), ln (parameter) = intercept + slope\\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln (0.8)/l n(r) to 1 + ln (1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose', 'unitOfMeasure': 'nanogram per millilitre (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-418F', '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'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TAK-418 5 mg', 'description': 'TAK-418 5 mg, capsule, orally, once on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: TAK-418 15 mg', 'description': 'TAK-418 15 mg, capsule, orally, once on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3A: TAK-418 30 mg Fasted', 'description': 'TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3B: TAK-418 30 mg Fed', 'description': 'TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 4: TAK-418 40 mg', 'description': 'TAK-418 40 mg, capsule, orally, once on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 5: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.000', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '1.02'}, {'value': '1.000', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.000', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '1.00'}, {'value': '3.000', 'groupId': 'OG003', 'lowerLimit': '1.50', 'upperLimit': '3.02'}, {'value': '1.250', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '1.52'}, {'value': '1.000', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose', 'description': 'The pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohorts 1-5: Placebo', 'description': 'TAK-418 placebo-matching, capsule, orally, once on Day 1.'}, {'id': 'FG001', 'title': 'Cohort 1: TAK-418 5 mg', 'description': 'TAK-418 5 milligram (mg), capsule, orally, once on Day 1.'}, {'id': 'FG002', 'title': 'Cohort 2: TAK-418 15 mg', 'description': 'TAK-418 15 mg, capsule, orally, once on Day 1.'}, {'id': 'FG003', 'title': 'Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed', 'description': 'TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1, followed by a 28-day washout period, further followed by TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.'}, {'id': 'FG004', 'title': 'Cohort 4: TAK-418 40 mg', 'description': 'TAK-418 40 mg, capsule, orally, once on Day 1.'}, {'id': 'FG005', 'title': 'Cohort 5: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Positive alcohol test', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at single site in the United States from 21 July 2017 to 12 May 2018.', 'preAssignmentDetails': 'Healthy participants were randomized to receive TAK-418 or matching placebo in Cohorts 1 to 5.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohorts 1-5: Placebo', 'description': 'TAK-418 placebo-matching, capsule, orally, once on Day 1.'}, {'id': 'BG001', 'title': 'Cohort 1: TAK-418 5 mg', 'description': 'TAK-418 5 mg, capsule, orally, once on Day 1.'}, {'id': 'BG002', 'title': 'Cohort 2: TAK-418 15 mg', 'description': 'TAK-418 15 mg, capsule, orally, once on Day 1.'}, {'id': 'BG003', 'title': 'Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed', 'description': 'TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1, followed by a 28-day washout period, further followed by TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.'}, {'id': 'BG004', 'title': 'Cohort 4: TAK-418 40 mg', 'description': 'TAK-418 40 mg, capsule, orally, once on Day 1.'}, {'id': 'BG005', 'title': 'Cohort 5: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once on Day 1.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'spread': '9.63', 'groupId': 'BG000'}, {'value': '37.2', 'spread': '10.42', 'groupId': 'BG001'}, {'value': '33.3', 'spread': '10.80', 'groupId': 'BG002'}, {'value': '40.0', 'spread': '10.60', 'groupId': 'BG003'}, {'value': '33.2', 'spread': '6.49', 'groupId': 'BG004'}, {'value': '38.7', 'spread': '10.03', 'groupId': 'BG005'}, {'value': '36.5', 'spread': '9.43', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '81.2', 'spread': '12.34', 'groupId': 'BG000'}, {'value': '76.0', 'spread': '13.58', 'groupId': 'BG001'}, {'value': '81.8', 'spread': '6.83', 'groupId': 'BG002'}, {'value': '82.5', 'spread': '4.22', 'groupId': 'BG003'}, {'value': '80.0', 'spread': '12.43', 'groupId': 'BG004'}, {'value': '76.1', 'spread': '15.23', 'groupId': 'BG005'}, {'value': '79.8', 'spread': '11.0', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '173.4', 'spread': '8.66', 'groupId': 'BG000'}, {'value': '171.0', 'spread': '8.10', 'groupId': 'BG001'}, {'value': '174.8', 'spread': '3.19', 'groupId': 'BG002'}, {'value': '172.5', 'spread': '5.09', 'groupId': 'BG003'}, {'value': '181.2', 'spread': '5.08', 'groupId': 'BG004'}, {'value': '171.5', 'spread': '11.78', 'groupId': 'BG005'}, {'value': '174.0', 'spread': '7.89', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.94', 'spread': '3.065', 'groupId': 'BG000'}, {'value': '25.82', 'spread': '2.440', 'groupId': 'BG001'}, {'value': '26.83', 'spread': '2.835', 'groupId': 'BG002'}, {'value': '27.83', 'spread': '2.414', 'groupId': 'BG003'}, {'value': '24.32', 'spread': '2.988', 'groupId': 'BG004'}, {'value': '25.73', 'spread': '2.992', 'groupId': 'BG005'}, {'value': '26.32', 'spread': '2.864', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The safety analysis set included all randomized participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-07', 'size': 987125, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-08T13:05', 'hasProtocol': True}, {'date': '2017-12-07', 'size': 539190, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-08T13:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-09', 'studyFirstSubmitDate': '2017-07-21', 'resultsFirstSubmitDate': '2019-05-08', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-09', 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Baseline Up to Day 184'}, {'measure': 'Number of Participants Who Discontinued Due to an Adverse Event (AE)', 'timeFrame': 'Baseline Up to Day 184'}, {'measure': 'Number of Participants Who Meet the Markedly Abnormal Criteria for Neurological Assessment Measurements at Least Once Post Dose', 'timeFrame': 'Baseline Up to Day 184'}, {'measure': 'Number of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose', 'timeFrame': 'Baseline Up to Day 184'}, {'measure': 'Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose', 'timeFrame': 'Baseline Up to day 184'}, {'measure': 'Number of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose', 'timeFrame': 'Baseline Up to Day 14'}], 'secondaryOutcomes': [{'measure': 'AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-418F (TAK-418 Free Base)', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose'}, {'measure': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418F', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose'}, {'measure': 'Cmax: Maximum Observed Plasma Concentration for TAK-418F', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose'}, {'measure': 'Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-418F', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose', 'description': 'The pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'references': [{'pmid': '33990969', 'type': 'DERIVED', 'citation': 'Yin W, Arkilo D, Khudyakov P, Hazel J, Gupta S, Quinton MS, Lin J, Hartman DS, Bednar MM, Rosen L, Wendland JR. Safety, pharmacokinetics and pharmacodynamics of TAK-418, a novel inhibitor of the epigenetic modulator lysine-specific demethylase 1A. Br J Clin Pharmacol. 2021 Dec;87(12):4756-4768. doi: 10.1111/bcp.14912. Epub 2021 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of TAK-418 following single oral doses in healthy participants.', 'detailedDescription': 'The drug being tested in this study is called TAK-418. TAK-418 is being tested in healthy participants in order to evaluate the safety, tolerability, and pharmacokinetics (PK) of single oral doses.\n\nThe study will enroll approximately 40 healthy participants. The study consists of equally divided 5 sequential cohorts of 8 participants each. In each of the following cohorts, 6 participants will be randomized to receive TAK-418 and 2 participants will receive matching placebo-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):\n\n* Cohort 1: TAK-418 5 mg\n* Cohort 2: TAK-418 15 mg\n* Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed\n* Cohort 4: TAK-418 40 mg\n* Cohort 5: TAK-418 60 mg\n\nAll participants will be asked to take TAK-418 or placebo-matching capsule once on Day 1 in each cohort. A washout period of 28-days will be maintained between the doses in Cohort 3.\n\nThis single center trial will be conducted in the United States. Participants in this study will be assigned to one of 5 possible dose cohorts. Male participants will return for additional outpatient visits on Days 91 and 93 (+/- 7 days) and may return for outpatient visits on Days 182 and 184 (+/- 7 days) (depending on results from the Day 93 Visit).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Is a male or female participants with a body mass index (BMI) within the range of 18.5 -30.0 kilogram per square meter (kg/m\\^2) at the Screening Visit.\n2. Is a nonsmoker who has not used tobacco or nicotine-containing products (example, nicotine patch) for at least 6 months before trial drug administration of the initial dose of trial drug or invasive procedure.\n3. Must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug or invasive procedure as per principal investigator's judgment.\n4. Female subjects with no childbearing potential, defined by at least 1 of the following criteria:\n\n * Postmenopausal (defined as 12 months of spontaneous amenorrhea in women aged greater than \\[\\>\\]45 years, 6 months of spontaneous amenorrhea in women aged \\>45 years with serum follicle-stimulating hormone \\[FSH\\] levels \\>40 milli-international units per milliliter \\[mIU/mL\\]). Appropriate documentation of FSH levels is required.\n * Surgically sterile by hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure.\n * Had a tubal ligation with appropriate documentation of surgical procedure.\n * Has a congenital condition resulting in no uterus.\n\nExclusion Criteria:\n\n1. Has had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter \\[mL\\]) within 4 weeks before the Screening Visit.\n2. Has a risk of suicide according to the investigator's clinical judgment per the Columbia-Suicide Severity Rating Scale at Screening or has made a suicide attempt in the 6 months before Screening."}, 'identificationModule': {'nctId': 'NCT03228433', 'briefTitle': 'A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Ascending Oral Single Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-418 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'TAK-418-1001'}, 'secondaryIdInfos': [{'id': 'U1111-1195-7777', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: TAK-418 5 mg', 'description': 'TAK-418 5 milligram (mg), capsule, orally, once on Day 1.', 'interventionNames': ['Drug: TAK-418']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: TAK-418 15 mg', 'description': 'TAK-418 15 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts.', 'interventionNames': ['Drug: TAK-418']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed', 'description': 'TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1, followed by a 28-day washout period, further followed by TAK-418 30 mg, capsule, in fed state, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts.', 'interventionNames': ['Drug: TAK-418']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: TAK-418 40 mg', 'description': 'TAK-418 40 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts.', 'interventionNames': ['Drug: TAK-418']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts.', 'interventionNames': ['Drug: TAK-418']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohorts 1-5: Placebo', 'description': 'TAK-418 placebo-matching, capsule, orally, once on Day 1.', 'interventionNames': ['Drug: TAK-418 Placebo']}], 'interventions': [{'name': 'TAK-418', 'type': 'DRUG', 'description': 'TAK-418 Capsule.', 'armGroupLabels': ['Cohort 1: TAK-418 5 mg', 'Cohort 2: TAK-418 15 mg', 'Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed', 'Cohort 4: TAK-418 40 mg', 'Cohort 5: TAK-418 60 mg']}, {'name': 'TAK-418 Placebo', 'type': 'DRUG', 'description': 'TAK-418 placebo-matching capsules.', 'armGroupLabels': ['Cohorts 1-5: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'PAREXEL International', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}