Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:28 PM
Study NCT ID:
NCT03501069
Status:
TERMINATED
Last Update Posted:
2020-06-16
First Post:
2018-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single and Multiple Oral Dose of TAK-418 in Healthy Female 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': 'TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)', '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': 'Non-Japanese Cohort 1; Period A: Placebo', 'description': 'TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-Japanese Cohort 1; Period B: Placebo', 'description': 'TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Non-Japanese Cohort 1: TAK 418 120 mg', 'description': 'TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Non-Japanese Cohort 1: TAK 418 160 mg', 'description': 'TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Non-Japanese Cohorts 2 to 4: Pooled Placebo', 'description': 'TAK-418 placebo-matching capsule, orally, once daily for 10 days.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Japanese Cohort 5: Placebo', 'description': 'TAK-418 placebo-matching capsule, orally, once daily for 10 days.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Non-Japanese Cohort 2: TAK-418 20 mg', 'description': 'TAK-418 20 mg, capsule, orally, once daily for 10 days.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Non-Japanese Cohort 3: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once daily for 10 days.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Non-Japanese Cohort 4: TAK-418 160 mg', 'description': 'TAK-418 160 mg, capsule, orally, once daily for 10 days.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Japanese Cohort 5: TAK-418 20 mg', 'description': 'TAK-418 20 mg, capsule, orally, once daily for 10 days.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 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{'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 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{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 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[{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Japanese Cohort 1; Period A: Placebo', 'description': 'TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.'}, {'id': 'OG001', 'title': 'Non-Japanese Cohort 1; Period B: Placebo', 'description': 'TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.'}, {'id': 'OG002', 'title': 'Non-Japanese Cohort 1: TAK 418 120 mg', 'description': 'TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.'}, {'id': 'OG003', 'title': 'Non-Japanese Cohort 1: TAK 418 160 mg', 'description': 'TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.'}], 'classes': [{'title': 'ECG Mean Heart Rate <50 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'QT Interval >=460 millisecond (msec)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 60', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set included all randomized participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Cohorts 2 to 5: Number of Participants Who Meet the Markedly Abnormal Values of 12-lead ECG Parameters at Least Once Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Japanese Cohorts 2 to 4: Pooled Placebo', 'description': 'TAK-418 placebo-matching capsule, orally, once daily for 10 days.'}, {'id': 'OG001', 'title': 'Japanese Cohort 5: Placebo', 'description': 'TAK-418 placebo-matching capsule, orally, once daily for 10 days.'}, {'id': 'OG002', 'title': 'Non-Japanese Cohort 2: TAK-418 20 mg', 'description': 'TAK-418 20 mg, capsule, orally, once daily for 10 days.'}, {'id': 'OG003', 'title': 'Non-Japanese Cohort 3: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once daily for 10 days.'}, {'id': 'OG004', 'title': 'Non-Japanese Cohort 4: TAK-418 160 mg', 'description': 'TAK-418 160 mg, capsule, orally, once daily for 10 days.'}, {'id': 'OG005', 'title': 'Japanese Cohort 5: TAK-418 20 mg', 'description': 'TAK-418 20 mg, capsule, orally, once daily for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 70', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set included all randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Cohort 1; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418 on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Japanese Cohort 1: TAK 418 120 mg', 'description': 'TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.'}, {'id': 'OG001', 'title': 'Non-Japanese Cohort 1: TAK 418 160 mg', 'description': 'TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.'}], 'classes': [{'categories': [{'measurements': [{'value': '3761.2', 'spread': '20.8', 'groupId': 'OG000'}, {'value': '4229.0', 'spread': '40.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose', 'unitOfMeasure': 'hour*nanogram per milliliter (hr*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) set included all participants from the safety set who had at least 1 measurable post dose plasma or cerebrospinal fluid (CSF) concentration or amount of drug in urine of TAK-418F.'}, {'type': 'SECONDARY', 'title': 'Cohort 2 to 5: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Over the Dosing Interval for TAK-418 on Days 1 and 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Japanese Cohort 2: TAK-418 20 mg', 'description': 'TAK-418 20 mg, capsule, orally, once daily for 10 days.'}, {'id': 'OG001', 'title': 'Non-Japanese Cohort 3: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once daily for 10 days.'}, {'id': 'OG002', 'title': 'Non-Japanese Cohort 4: TAK-418 160 mg', 'description': 'TAK-418 160 mg, capsule, orally, once daily for 10 days.'}, {'id': 'OG003', 'title': 'Japanese Cohort 5: TAK-418 20 mg', 'description': 'TAK-418 20 mg, capsule, orally, once daily for 10 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '503.3', 'spread': '165.71', 'groupId': 'OG000'}, {'value': '1445.5', 'spread': '353.26', 'groupId': 'OG001'}, {'value': '3747.3', 'spread': '239.53', 'groupId': 'OG002'}, {'value': '610.3', 'spread': '87.89', 'groupId': 'OG003'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '668.2', 'spread': '228.83', 'groupId': 'OG000'}, {'value': '1660.5', 'spread': '421.77', 'groupId': 'OG001'}, {'value': '4058.3', 'spread': '249.49', 'groupId': 'OG002'}, {'value': '677.3', 'spread': '73.66', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 10 pre-dose and at multiple time points (up to 24 hours) post-dose', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants from the safety set who had at least 1 measurable post dose plasma or CSF concentration or amount of drug in urine of TAK-418F.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for TAK-418', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Japanese Cohort 1: TAK 418 120 mg', 'description': 'TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.'}, {'id': 'OG001', 'title': 'Non-Japanese Cohort 1: TAK 418 160 mg', 'description': 'TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.'}, {'id': 'OG002', 'title': 'Non-Japanese Cohort 2: TAK-418 20 mg', 'description': 'TAK-418 20 mg, capsule, orally, once daily for 10 days.'}, {'id': 'OG003', 'title': 'Non-Japanese Cohort 3: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once daily for 10 days.'}, {'id': 'OG004', 'title': 'Non-Japanese Cohort 4: TAK-418 160 mg', 'description': 'TAK-418 160 mg, capsule, orally, once daily for 10 days.'}, {'id': 'OG005', 'title': 'Japanese Cohort 5: TAK-418 20 mg', 'description': 'TAK-418 20 mg, capsule, orally, once daily for 10 days.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '714.7', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '750.3', 'spread': '40.3', 'groupId': 'OG001'}, {'value': '81.1', 'spread': '35.8', 'groupId': 'OG002'}, {'value': '270.8', 'spread': '21.6', 'groupId': 'OG003'}, {'value': '657.8', 'spread': '33.0', 'groupId': 'OG004'}, {'value': '154.5', 'spread': '5.9', 'groupId': 'OG005'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '113.4', 'spread': '30.8', 'groupId': 'OG002'}, {'value': '303.4', 'spread': '17.6', 'groupId': 'OG003'}, {'value': '692.4', 'spread': '15.4', 'groupId': 'OG004'}, {'value': '171.1', 'spread': '5.9', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohort 1: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohorts 2 to 5: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants from the safety set who had at least 1 measurable post dose plasma or CSF concentration or amount of drug in urine of TAK-418F. PK-evaluable population where data at specified time points was available.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time to Reach the Cmax for TAK-418', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Japanese Cohort 1: TAK 418 120 mg', 'description': 'TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.'}, {'id': 'OG001', 'title': 'Non-Japanese Cohort 1: TAK 418 160 mg', 'description': 'TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.'}, {'id': 'OG002', 'title': 'Non-Japanese Cohort 2: TAK-418 20 mg', 'description': 'TAK-418 20 mg, capsule, orally, once daily for 10 days.'}, {'id': 'OG003', 'title': 'Non-Japanese Cohort 3: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once daily for 10 days.'}, {'id': 'OG004', 'title': 'Non-Japanese Cohort 4: TAK-418 160 mg', 'description': 'TAK-418 160 mg, capsule, orally, once daily for 10 days.'}, {'id': 'OG005', 'title': 'Japanese Cohort 5: TAK-418 20 mg', 'description': 'TAK-418 20 mg, capsule, orally, once daily for 10 days.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.500', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '1.250', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.750', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.500', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '1.500', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.000', 'groupId': 'OG005', 'lowerLimit': '0.50', 'upperLimit': '1.50'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.260', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.250', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.000', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '1.000', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '1.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohort 1: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohorts 2 to 5: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants from the safety set who had at least 1 measurable post dose plasma or CSF concentration or amount of drug in urine of TAK-418F. PK-evaluable population where data at specified time points was available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-Japanese Cohort 1: TAK-418 120 mg + Placebo', 'description': 'TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 120 mg placebo-matching capsule, orally, once on Day 1 of Period B.'}, {'id': 'FG001', 'title': 'Non-Japanese Cohort 1: TAK-418 120 mg + TAK-418 160 mg', 'description': 'TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B.'}, {'id': 'FG002', 'title': 'Non-Japanese Cohort 1: Placebo + TAK-418 160 mg', 'description': 'TAK-418 160 mg placebo-matching capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B.'}, {'id': 'FG003', 'title': 'Non-Japanese Cohorts 2 to 4: Pooled Placebo', 'description': 'TAK-418 placebo-matching capsule, orally, once daily for 10 days.'}, {'id': 'FG004', 'title': 'Japanese Cohort 5: Placebo', 'description': 'TAK-418 placebo-matching capsule, orally, once daily for 10 days.'}, {'id': 'FG005', 'title': 'Non-Japanese Cohort 2: TAK-418 20 mg', 'description': 'TAK-418 20 mg, capsule, orally, once daily for 10 days.'}, {'id': 'FG006', 'title': 'Non-Japanese Cohort 3: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once daily for 10 days.'}, {'id': 'FG007', 'title': 'Non-Japanese Cohort 4: TAK-418 160 mg', 'description': 'TAK-418 160 mg, capsule, orally, once daily for 10 days.'}, {'id': 'FG008', 'title': 'Japanese Cohort 5: TAK-418 20 mg', 'description': 'TAK-418 20 mg, capsule, orally, once daily for 10 days.'}], 'periods': [{'title': 'Period A', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Washout Period (at Least 14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'comment': 'Participants other than Cohort 1 were not to continue in subsequent Periods after Period A.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Participants other than Cohort 1 were not to continue in subsequent Periods after Period A.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Participants other than Cohort 1 were not to continue in subsequent Periods after Period A.', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'Participants other than Cohort 1 were not to continue in subsequent Periods after Period A.', 'groupId': 'FG006', 'numSubjects': '0'}, {'comment': 'Participants other than Cohort 1 were not to continue in subsequent Periods after Period A.', 'groupId': 'FG007', 'numSubjects': '0'}, {'comment': 'Participants other than Cohort 1 were not to continue in subsequent Periods after Period A.', 'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Period B', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'comment': 'Participants other than Cohort 1 were not to continue in subsequent Periods after Period A.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Participants other than Cohort 1 were not to continue in subsequent Periods after Period A.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Participants other than Cohort 1 were not to continue in subsequent Periods after Period A.', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'Participants other than Cohort 1 were not to continue in subsequent Periods after Period A.', 'groupId': 'FG006', 'numSubjects': '0'}, {'comment': 'Participants other than Cohort 1 were not to continue in subsequent Periods after Period A.', 'groupId': 'FG007', 'numSubjects': '0'}, {'comment': 'Participants other than Cohort 1 were not to continue in subsequent Periods after Period A.', 'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 2 investigative sites in the United States from 30 May 2018 to 26 December 2018.', 'preAssignmentDetails': 'Healthy female participants were enrolled to receive TAK-418 as single rising dose (SRD) dose of 120 milligram (mg), or 160 mg (non-Japanese cohort), and/or placebo in a crossover fashion; and multiple rising dose (MRD) of 20 mg, 60 mg, 160 mg (non-Japanese cohort) or 20 mg (Japanese cohort). The study was terminated early due to business decision.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '32', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-Japanese Cohort 1: TAK-418 120 mg + Placebo', 'description': 'TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 120 mg placebo-matching capsule, orally, once on Day 1 of Period B.'}, {'id': 'BG001', 'title': 'Non-Japanese Cohort 1: TAK-418 120 mg + TAK-418 160 mg', 'description': 'TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B.'}, {'id': 'BG002', 'title': 'Non-Japanese Cohort 1: Placebo + TAK-418 160 mg', 'description': 'TAK-418 160 mg placebo-matching capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B.'}, {'id': 'BG003', 'title': 'Non-Japanese Cohorts 2 to 4: Pooled Placebo', 'description': 'TAK-418 placebo-matching capsule, orally, once daily for 10 days.'}, {'id': 'BG004', 'title': 'Japanese Cohort 5: Placebo', 'description': 'TAK-418 placebo-matching capsule, orally, once daily for 10 days.'}, {'id': 'BG005', 'title': 'Non-Japanese Cohort 2: TAK-418 20 mg', 'description': 'TAK-418 20 mg, capsule, orally, once daily for 10 days.'}, {'id': 'BG006', 'title': 'Non-Japanese Cohort 3: TAK-418 60 mg', 'description': 'TAK-418 60 mg, capsule, orally, once daily for 10 days.'}, {'id': 'BG007', 'title': 'Non-Japanese Cohort 4: TAK-418 160 mg', 'description': 'TAK-418 160 mg, capsule, orally, once daily for 10 days.'}, {'id': 'BG008', 'title': 'Japanese Cohort 5: TAK-418 20 mg', 'description': 'TAK-418 20 mg, capsule, orally, once daily for 10 days.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.5', 'spread': '7.78', 'groupId': 'BG000'}, {'value': '39.8', 'spread': '11.32', 'groupId': 'BG001'}, {'value': '39.0', 'spread': '18.38', 'groupId': 'BG002'}, {'value': '47.8', 'spread': '11.78', 'groupId': 'BG003'}, {'value': '49.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was analyzed.', 'groupId': 'BG004'}, {'value': '39.2', 'spread': '12.32', 'groupId': 'BG005'}, {'value': '46.7', 'spread': '10.93', 'groupId': 'BG006'}, {'value': '43.3', 'spread': '4.04', 'groupId': 'BG007'}, {'value': '50.3', 'spread': '3.51', 'groupId': 'BG008'}, {'value': '43.4', 'spread': '10.60', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '32', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '28', 'groupId': 'BG009'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}], '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': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Asian', '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': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}]}, {'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': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '22', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '32', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '71.050', 'spread': '9.8288', 'groupId': 'BG000'}, {'value': '67.875', 'spread': '5.5506', 'groupId': 'BG001'}, {'value': '66.250', 'spread': '13.7886', 'groupId': 'BG002'}, {'value': '70.60', 'spread': '7.090', 'groupId': 'BG003'}, {'value': '67.90', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was analyzed.', 'groupId': 'BG004'}, {'value': '66.60', 'spread': '6.690', 'groupId': 'BG005'}, {'value': '70.22', 'spread': '9.100', 'groupId': 'BG006'}, {'value': '78.27', 'spread': '5.848', 'groupId': 'BG007'}, {'value': '49.60', 'spread': '3.857', 'groupId': 'BG008'}, {'value': '67.859', 'spread': '9.4141', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '173.00', 'spread': '5.657', 'groupId': 'BG000'}, {'value': '161.00', 'spread': '4.243', 'groupId': 'BG001'}, {'value': '166.50', 'spread': '6.364', 'groupId': 'BG002'}, {'value': '162.8', 'spread': '7.85', 'groupId': 'BG003'}, {'value': '167.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was analyzed.', 'groupId': 'BG004'}, {'value': '164.7', 'spread': '6.47', 'groupId': 'BG005'}, {'value': '163.0', 'spread': '8.15', 'groupId': 'BG006'}, {'value': '172.3', 'spread': '7.23', 'groupId': 'BG007'}, {'value': '154.7', 'spread': '2.52', 'groupId': 'BG008'}, {'value': '164.09', 'spread': '7.485', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '23.90', 'spread': '4.808', 'groupId': 'BG000'}, {'value': '26.23', 'spread': '2.636', 'groupId': 'BG001'}, {'value': '23.75', 'spread': '3.182', 'groupId': 'BG002'}, {'value': '26.62', 'spread': '1.599', 'groupId': 'BG003'}, {'value': '24.30', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was analyzed.', 'groupId': 'BG004'}, {'value': '24.53', 'spread': '1.401', 'groupId': 'BG005'}, {'value': '26.42', 'spread': '2.872', 'groupId': 'BG006'}, {'value': '26.47', 'spread': '3.202', 'groupId': 'BG007'}, {'value': '20.77', 'spread': '1.553', 'groupId': 'BG008'}, {'value': '25.16', 'spread': '2.775', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The safety set included all randomized participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-20', 'size': 19752171, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-12-13T09:59', 'hasProtocol': True}, {'date': '2019-01-28', 'size': 4911527, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-12-13T09:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'whyStopped': 'Business Decision; no human safety concern; evaluating preclinical toxicology finding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-03', 'studyFirstSubmitDate': '2018-04-10', 'resultsFirstSubmitDate': '2019-12-13', 'studyFirstSubmitQcDate': '2018-04-10', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-03', 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohort 1: Number of Participants Who Experienced at Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAE)', 'timeFrame': 'Baseline up to Day 60'}, {'measure': 'Cohorts 2 to 5: Number of Participants Who Experienced at Least One TEAEs and SAE', 'timeFrame': 'Baseline up to Day 70'}, {'measure': 'Cohort 1: Number of Participants With Markedly Abnormal Criteria for Clinical Laboratory Values at Least Once Postdose', 'timeFrame': 'Baseline up to Day 60'}, {'measure': 'Cohorts 2 to 5: Number of Participants With Markedly Abnormal Criteria for Clinical Laboratory Values at Least Once Postdose', 'timeFrame': 'Baseline up to Day 70'}, {'measure': 'Cohort 1: Number of Participants With Markedly Abnormal Criteria for Vital Signs at Least Once Postdose', 'timeFrame': 'Baseline up to Day 60'}, {'measure': 'Cohorts 2 to 5: Number of Participants With Markedly Abnormal Criteria for Vital Signs at Least Once Postdose', 'timeFrame': 'Baseline up to Day 70'}, {'measure': 'Cohort 1: Number of Participants Who Meet the Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose', 'timeFrame': 'Baseline up to Day 60'}, {'measure': 'Cohorts 2 to 5: Number of Participants Who Meet the Markedly Abnormal Values of 12-lead ECG Parameters at Least Once Post Dose', 'timeFrame': 'Baseline up to Day 70'}], 'secondaryOutcomes': [{'measure': 'Cohort 1; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418 on Day 1', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose'}, {'measure': 'Cohort 2 to 5: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Over the Dosing Interval for TAK-418 on Days 1 and 10', 'timeFrame': 'Days 1 and 10 pre-dose and at multiple time points (up to 24 hours) post-dose'}, {'measure': 'Cmax: Maximum Observed Plasma Concentration for TAK-418', 'timeFrame': 'Cohort 1: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohorts 2 to 5: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose'}, {'measure': 'Tmax: Time to Reach the Cmax for TAK-418', 'timeFrame': 'Cohort 1: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohorts 2 to 5: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Healthy Volunteers']}, '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 characterize safety and tolerability of TAK-418 in non-Japanese and Japanese healthy female participants when administered at single or multiple (once daily \\[QD\\]) oral doses.', 'detailedDescription': 'The drug being tested in this study is called TAK-418. This study will assess the safety, tolerability, PK and PD of single and multiple rising doses of TAK-418 in healthy Japanese or non-Japanese females.\n\nThe study will enroll approximately 48 participants in 6 cohorts and each cohort will have 8 participants. The study will include 2 parts: single rising dose (SRD) in Cohort 1 and multiple rising dose (MRD) in Cohorts 2 to 6. Cohort 3 will include cerebrospinal fluid (CSF) collection. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 6 cohorts.\n\nThis two-center trial will be conducted in the United States. The overall time to participate in Cohort 1 of this study is approximately 105 days and 98 days in Cohort 2. Participants will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Has a body mass index (BMI) greater than or equal to (\\>=) 18.5 and less than or equal to (\\<=) 30.0 kilogram per square meter (kg/m\\^2) at the Screening Visit. (Cohorts 1 to 4 only).\n2. Is a nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before administration of the first dose of trial drug or invasive procedure.\n3. The participant either is of nonchildbearing potential, OR, if of childbearing potential, is using a highly effective method of contraception with low user dependency during the entire duration of the study.\n\nFor Cohorts 5 and 6 (Japanese participants) only:\n\n1\\. Has a BMI \\>=18.0 and \\<= 26.0 kg/m\\^2, at the Screening Visit.\n\nExclusion Criteria:\n\n1. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), or human immunodeficiency virus (HIV) antibody/antigen, at Screening.\n2. Had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter \\[mL\\]) within 4 weeks before the Screening Visit.\n3. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to beer \\[354 mL/12 ounces\\], wine \\[118 mL/4 ounces\\], or distilled spirits \\[29.5 mL/1 ounce\\] per day).\n4. Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.\n5. Has a substance abuse disorder.\n6. Has risk of suicide according to the investigator's clinical judgment per Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening or has made a suicide attempt in the 6 months before Screening.\n7. Has luteinizing hormone (LH), follicle-stimulating hormone (FSH), or estradiol levels that are clinically abnormal.\n8. Has a resting heart rate outside of the range of 50 to 100 beats per minute, confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (Day -1).\n\nFor Cohort 3 only (includes CSF sample collection):\n\n1. Has had CSF collection performed within 30 days before Check-in (Day -1).\n2. Has significant vertebral deformities (scoliosis or kyphosis) that, in the opinion of the investigator, may interfere with the lumbar puncture procedure.\n3. Has a local infection at the puncture site.\n4. Has thrombocytopenia or other suspected bleeding tendencies noted before the procedure.\n5. Has developed signs and symptoms of spinal radiculopathy, including lower extremity pain and paresthesia.\n6. Has any focal neurological deficit that might suggest an increase in intracranial pressure.\n7. Has any abnormal finding on ophthalmological assessment/fundoscopy indicative of raised intracranial pressure (that is, optic disc swelling/edema; or \\[uncontrolled\\] hypertensive retinopathy).\n8. Regularly has moderate-to-severe headaches requiring analgesics.\n9. Has any bleeding abnormality or history of bleeding abnormalities.\n10. Has abnormal coagulation tests (prothrombin time \\[PT\\]/international normalized ratio \\[INR\\], partial thromboplastin time \\[PTT\\]) at Screening."}, 'identificationModule': {'nctId': 'NCT03501069', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single and Multiple Oral Dose of TAK-418 in Healthy Female Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-418 in Healthy Female Subjects', 'orgStudyIdInfo': {'id': 'TAK-418-1003'}, 'secondaryIdInfos': [{'id': 'U1111-1209-4647', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-Japanese Cohort 1: TAK-418 120 mg and TAK-418 160 mg', 'description': 'TAK-418 120 milligram (mg) or TAK-418 matching placebo, capsule, orally, once on Day 1 of Period A followed by a minimum of 14 days of washout period, followed by TAK-418 160 mg or TAK-418 matching placebo, capsule, orally, once on Day 1 of Period B. The actual TAK-418 dose for Period B will be determined based on safety, tolerability, and PK data available from the previous dose in Period A.', 'interventionNames': ['Drug: TAK-418', 'Drug: TAK-418 Matching Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Non-Japanese Cohort 2: TAK-418 20 mg', 'description': 'TAK-418 20 mg or TAK-418 matching placebo, capsule, orally, once daily for 10 days.', 'interventionNames': ['Drug: TAK-418', 'Drug: TAK-418 Matching Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Non-Japanese Cohort 3: TAK-418 40 mg', 'description': 'TAK-418 40 mg or TAK-418 matching placebo, capsule, orally, once daily for 10 days. The actual TAK-418 dose for Cohort 3 will be determined based on safety, tolerability, and PK data available from the previous doses.', 'interventionNames': ['Drug: TAK-418', 'Drug: TAK-418 Matching Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Non-Japanese Cohort 4: TAK-418 60 mg', 'description': 'TAK-418 60 mg or TAK-418 matching placebo, capsule, orally, once daily for 10 days. The actual TAK-418 dose for Cohort 4 will be determined based on safety, tolerability, and PK data available from the previous doses.', 'interventionNames': ['Drug: TAK-418', 'Drug: TAK-418 Matching Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Japanese Cohort 5: TAK-418 20 mg', 'description': 'TAK-418 20 mg or TAK-418 matching placebo, capsule, orally, once daily for 10 days. The actual TAK-418 dose for Cohort 5 will be determined based on safety, tolerability, and PK data available from the previous doses.', 'interventionNames': ['Drug: TAK-418', 'Drug: TAK-418 Matching Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Japanese Cohort 6: TAK-418 40 mg', 'description': 'TAK-418 40 mg or TAK-418 matching placebo, capsule, orally, once daily for 10 days. The actual TAK-418 dose for Cohort 6 will be determined based on safety, tolerability, and PK data available from the previous doses.', 'interventionNames': ['Drug: TAK-418', 'Drug: TAK-418 Matching Placebo']}], 'interventions': [{'name': 'TAK-418', 'type': 'DRUG', 'description': 'TAK-418 capsules.', 'armGroupLabels': ['Japanese Cohort 5: TAK-418 20 mg', 'Japanese Cohort 6: TAK-418 40 mg', 'Non-Japanese Cohort 1: TAK-418 120 mg and TAK-418 160 mg', 'Non-Japanese Cohort 2: TAK-418 20 mg', 'Non-Japanese Cohort 3: TAK-418 40 mg', 'Non-Japanese Cohort 4: TAK-418 60 mg']}, {'name': 'TAK-418 Matching Placebo', 'type': 'DRUG', 'description': 'TAK-418 matching placebo capsules.', 'armGroupLabels': ['Japanese Cohort 5: TAK-418 20 mg', 'Japanese Cohort 6: TAK-418 40 mg', 'Non-Japanese Cohort 1: TAK-418 120 mg and TAK-418 160 mg', 'Non-Japanese Cohort 2: TAK-418 20 mg', 'Non-Japanese Cohort 3: TAK-418 40 mg', 'Non-Japanese Cohort 4: TAK-418 60 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Parexel International', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'PRA Health Sciences', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], '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 for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com 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': 'Millennium Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}