Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-30 @ 9:54 AM
Study NCT ID:
NCT05284760
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2022-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Soticlestat Tablets in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712808', 'term': 'soticlestat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TrialDisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Study Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "No publication related to study results was made without Sponsor's prior written approval. Any proposed publication or presentation was submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From screening up to 14 days after the last dose of soticlestat (Day 51)', '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': 'Part A: Treatment A', 'description': 'Soticlestat T4 tablets 300 mg, orally, once on Day 1 of each period under fasted condition.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 4, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A: Treatment B', 'description': 'Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of each period under fasted condition.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 5, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A: Treatment C', 'description': 'Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of each period under fasted condition.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 0, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part B: Treatment D', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fasted condition.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part B: Treatment E', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fed condition.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 2, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part B: Treatment F', 'description': 'Soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of each period under fasted condition.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 1, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for Soticlestat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A - Treatment A', 'description': 'Soticlestat T4 tablets 300 mg, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG001', 'title': 'Part A - Treatment B', 'description': 'Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG002', 'title': 'Part A - Treatment C', 'description': 'Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG003', 'title': 'Part B - Treatment D', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG004', 'title': 'Part B - Treatment E', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fed condition.'}, {'id': 'OG005', 'title': 'Part B - Treatment F', 'description': 'Soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of each period under fasted condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '1762', 'spread': '66.3', 'groupId': 'OG000'}, {'value': '1428', 'spread': '76.0', 'groupId': 'OG001'}, {'value': '1708', 'spread': '65.1', 'groupId': 'OG002'}, {'value': '1509', 'spread': '65.7', 'groupId': 'OG003'}, {'value': '565.6', 'spread': '49.0', 'groupId': 'OG004'}, {'value': '1350', 'spread': '63.1', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Mean Ratio (GMR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.28', 'ciLowerLimit': '87.66', 'ciUpperLimit': '107.96', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '81.04', 'ciLowerLimit': '73.06', 'ciUpperLimit': '89.89', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '37.48', 'ciLowerLimit': '31.10', 'ciUpperLimit': '45.17', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.45', 'ciLowerLimit': '74.24', 'ciUpperLimit': '107.79', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose', 'unitOfMeasure': 'nanogram per milllilitre (ng/ml)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied sufficiently with the protocol and displayed an evaluable Pharmacokinetic (PK) profile (eg, exposure to treatment, availability of measurements, and absence of major protocol violations) were included in the PK set.'}, {'type': 'PRIMARY', 'title': 'AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A - Treatment A', 'description': 'Soticlestat T4 tablets 300 mg, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG001', 'title': 'Part A - Treatment B', 'description': 'Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG002', 'title': 'Part A - Treatment C', 'description': 'Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG003', 'title': 'Part B - Treatment D', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG004', 'title': 'Part B - Treatment E', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fed condition.'}, {'id': 'OG005', 'title': 'Part B - Treatment F', 'description': 'Soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of each period under fasted condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '1649', 'spread': '50.2', 'groupId': 'OG000'}, {'value': '1433', 'spread': '54.8', 'groupId': 'OG001'}, {'value': '1606', 'spread': '51.6', 'groupId': 'OG002'}, {'value': '1503', 'spread': '49.1', 'groupId': 'OG003'}, {'value': '1317', 'spread': '37.0', 'groupId': 'OG004'}, {'value': '1435', 'spread': '61.9', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.52', 'ciLowerLimit': '92.17', 'ciUpperLimit': '103.17', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '86.88', 'ciLowerLimit': '82.14', 'ciUpperLimit': '91.89', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '87.63', 'ciLowerLimit': '75.92', 'ciUpperLimit': '101.15', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.49', 'ciLowerLimit': '82.73', 'ciUpperLimit': '110.22', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose', 'unitOfMeasure': 'ng.hour (hr)/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied sufficiently with the protocol and displayed an evaluable PK profile (eg, exposure to treatment, availability of measurements, and absence of major protocol violations) were included in the PK set.'}, {'type': 'PRIMARY', 'title': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A - Treatment A', 'description': 'Soticlestat T4 tablets 300 mg, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG001', 'title': 'Part A - Treatment B', 'description': 'Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG002', 'title': 'Part A - Treatment C', 'description': 'Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG003', 'title': 'Part B - Treatment D', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG004', 'title': 'Part B - Treatment E', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fed condition.'}, {'id': 'OG005', 'title': 'Part B - Treatment F', 'description': 'Soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of each period under fasted condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '1659', 'spread': '51.0', 'groupId': 'OG000'}, {'value': '1459', 'spread': '58.1', 'groupId': 'OG001'}, {'value': '1639', 'spread': '53.7', 'groupId': 'OG002'}, {'value': '1525', 'spread': '50.6', 'groupId': 'OG003'}, {'value': '1354', 'spread': '35.1', 'groupId': 'OG004'}, {'value': '1395', 'spread': '49.6', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.25', 'ciLowerLimit': '92.84', 'ciUpperLimit': '106.10', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '86.98', 'ciLowerLimit': '81.33', 'ciUpperLimit': '93.03', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.28', 'ciLowerLimit': '78.92', 'ciUpperLimit': '100.99', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.77', 'ciLowerLimit': '81.77', 'ciUpperLimit': '105.25', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose', 'unitOfMeasure': 'ng.hr/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied sufficiently with the protocol and displayed an evaluable PK profile (eg, exposure to treatment, availability of measurements, and absence of major protocol violations) were included in the PK set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A - Treatment A', 'description': 'Soticlestat T4 tablets 300 mg, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG001', 'title': 'Part A - Treatment B', 'description': 'Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG002', 'title': 'Part A - Treatment C', 'description': 'Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG003', 'title': 'Part B - Treatment D', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fasted condition.'}, {'id': 'OG004', 'title': 'Part B - Treatment E', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fed condition.'}, {'id': 'OG005', 'title': 'Part B - Treatment F', 'description': 'Soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of each period under fasted condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening up to 14 days after the last dose of soticlestat (Day 51)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the study drug(s) were included in the safety set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A, Sequence 1: Treatment A + Treatment B + Treatment C', 'description': 'Soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment A, followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment B, and followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment C. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'FG001', 'title': 'Part A, Sequence 2: Treatment A + Treatment C + Treatment B', 'description': 'Soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment A, followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment C, and followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment B. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'FG002', 'title': 'Part A, Sequence 3: Treatment B + Treatment A + Treatment C', 'description': 'Soticlestat T3 mini-tablets 300 milligram (mg), orally, once on Day 1 of Period 1 under fasted condition as Treatment B, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment A, and followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment C. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'FG003', 'title': 'Part A, Sequence 4: Treatment B + Treatment C + Treatment A', 'description': 'Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment B, followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment C, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment A. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'FG004', 'title': 'Part A, Sequence 5: Treatment C + Treatment A + Treatment B', 'description': 'Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment C, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment A, and followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment B. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'FG005', 'title': 'Part A, Sequence 6: Treatment C + Treatment B + Treatment A', 'description': 'Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment C, followed by soticlestat T3 mini-tablets 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment B, and followed by soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment A. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'FG006', 'title': 'Part B, Sequence 1: Treatment D + Treatment E + Treatment F', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fasted condition as Treatment D, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fed condition as Treatment E, and followed by soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 3 under fasted condition as Treatment F. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'FG007', 'title': 'Part B, Sequence 2: Treatment D + Treatment F + Treatment E', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fasted condition as Treatment D, followed by soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 2 under fasted condition as Treatment F, and followed by soticlestat T4 300 mg, orally, once on Day 1 of Period 3 under fed condition as Treatment E. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'FG008', 'title': 'Part B, Sequence 3: Treatment E + Treatment D + Treatment F', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fed condition as Treatment E, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment D, and followed by soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 3 under fasted condition as Treatment F. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'FG009', 'title': 'Part B, Sequence 4: Treatment E + Treatment F + Treatment D', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fed condition as Treatment E, followed by soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 2 under fasted condition as Treatment F, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment D. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'FG010', 'title': 'Part B, Sequence 5: Treatment F + Treatment D + Treatment E', 'description': 'Soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 1 under fasted condition as Treatment F, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment D, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fed condition as Treatment E. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'FG011', 'title': 'Part B, Sequence 6: Treatment F + Treatment E + Treatment D', 'description': 'Soticlestat T4 300 mg tablets, crushed and mixed with applesauce, orally, once on Day 1 of Period 1 under fasted condition as Treatment F, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fed condition as Treatment E, and followed by soticlestat T4 300 mg tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment D. A washout interval of exactly 4 days was maintained between each Treatment Period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '96', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A, Sequence 1: Treatment A + Treatment B + Treatment C', 'description': 'Soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment A, followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment B, and followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment C. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'BG001', 'title': 'Part A, Sequence 2: Treatment A + Treatment C + Treatment B', 'description': 'Soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment A, followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment C, and followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment B. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'BG002', 'title': 'Part A, Sequence 3: Treatment B + Treatment A + Treatment C', 'description': 'Soticlestat T3 mini-tablets 300 milligram (mg), orally, once on Day 1 of Period 1 under fasted condition as Treatment B, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment A, and followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment C. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'BG003', 'title': 'Part A, Sequence 4: Treatment B + Treatment C + Treatment A', 'description': 'Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment B, followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment C, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment A. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'BG004', 'title': 'Part A, Sequence 5: Treatment C + Treatment A + Treatment B', 'description': 'Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment C, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment A, and followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment B. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'BG005', 'title': 'Part A, Sequence 6: Treatment C + Treatment B + Treatment A', 'description': 'Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment C, followed by soticlestat T3 mini-tablets 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment B, and followed by soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment A. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'BG006', 'title': 'Part B, Sequence 1: Treatment D + Treatment E + Treatment F', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fasted condition as Treatment D, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fed condition as Treatment E, and followed by soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 3 under fasted condition as Treatment F. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'BG007', 'title': 'Part B, Sequence 2: Treatment D + Treatment F + Treatment E', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fasted condition as Treatment D, followed by soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 2 under fasted condition as Treatment F, and followed by soticlestat T4 300 mg, orally, once on Day 1 of Period 3 under fed condition as Treatment E. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'BG008', 'title': 'Part B, Sequence 3: Treatment E + Treatment D + Treatment F', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fed condition as Treatment E, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment D, and followed by soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 3 under fasted condition as Treatment F. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'BG009', 'title': 'Part B, Sequence 4: Treatment E + Treatment F + Treatment D', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fed condition as Treatment E, followed by soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 2 under fasted condition as Treatment F, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment D. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'BG010', 'title': 'Part B, Sequence 5: Treatment F + Treatment D + Treatment E', 'description': 'Soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 1 under fasted condition as Treatment F, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment D, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fed condition as Treatment E. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'BG011', 'title': 'Part B, Sequence 6: Treatment F + Treatment E + Treatment D', 'description': 'Soticlestat T4 300 mg tablets, crushed and mixed with applesauce, orally, once on Day 1 of Period 1 under fasted condition as Treatment F, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fed condition as Treatment E, and followed by soticlestat T4 300 mg tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment D. A washout interval of exactly 4 days was maintained between each Treatment Period.'}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '54'}, {'value': '38.3', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '52'}, {'value': '43.1', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '55'}, {'value': '38.3', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '54'}, {'value': '40.4', 'groupId': 'BG004', 'lowerLimit': '25', 'upperLimit': '54'}, {'value': '40.3', 'groupId': 'BG005', 'lowerLimit': '28', 'upperLimit': '53'}, {'value': '40.0', 'groupId': 'BG006', 'lowerLimit': '36', 'upperLimit': '52'}, {'value': '37.8', 'groupId': 'BG007', 'lowerLimit': '32', 'upperLimit': '44'}, {'value': '49.5', 'groupId': 'BG008', 'lowerLimit': '46', 'upperLimit': '53'}, {'value': '42.3', 'groupId': 'BG009', 'lowerLimit': '35', 'upperLimit': '49'}, {'value': '30.3', 'groupId': 'BG010', 'lowerLimit': '20', 'upperLimit': '50'}, {'value': '38.3', 'groupId': 'BG011', 'lowerLimit': '30', 'upperLimit': '45'}, {'value': '40.1', 'groupId': 'BG012', 'lowerLimit': '20', 'upperLimit': '55'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '23', 'groupId': 'BG012'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '73', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '75', 'groupId': 'BG012'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '21', 'groupId': 'BG012'}]}, {'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'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}]}], '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'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'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'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '10', 'groupId': 'BG012'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '85', 'groupId': 'BG012'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}]}, {'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'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.626', 'groupId': 'BG000', 'lowerLimit': '21.23', 'upperLimit': '31.28'}, {'value': '27.249', 'groupId': 'BG001', 'lowerLimit': '22.97', 'upperLimit': '31.23'}, {'value': '27.859', 'groupId': 'BG002', 'lowerLimit': '25.48', 'upperLimit': '30.85'}, {'value': '27.943', 'groupId': 'BG003', 'lowerLimit': '24.07', 'upperLimit': '31.68'}, {'value': '26.840', 'groupId': 'BG004', 'lowerLimit': '20.89', 'upperLimit': '30.97'}, {'value': '26.626', 'groupId': 'BG005', 'lowerLimit': '21.23', 'upperLimit': '31.28'}, {'value': '26.843', 'groupId': 'BG006', 'lowerLimit': '24.61', 'upperLimit': '28.18'}, {'value': '26.285', 'groupId': 'BG007', 'lowerLimit': '23.49', 'upperLimit': '29.24'}, {'value': '28.030', 'groupId': 'BG008', 'lowerLimit': '25.76', 'upperLimit': '31.62'}, {'value': '27.120', 'groupId': 'BG009', 'lowerLimit': '24.98', 'upperLimit': '29.10'}, {'value': '26.130', 'groupId': 'BG010', 'lowerLimit': '22.07', 'upperLimit': '28.27'}, {'value': '26.960', 'groupId': 'BG011', 'lowerLimit': '23.58', 'upperLimit': '30.91'}, {'value': '27.286', 'groupId': 'BG012', 'lowerLimit': '20.89', 'upperLimit': '31.68'}]}]}], 'paramType': 'MEAN', 'description': 'BMI was calculated based on the height and weight, using the formula: BMI = weight (kg)/\\[height (m)\\^2\\].', 'unitOfMeasure': 'kilogram per meters squared (kg/m^2)', 'dispersionType': 'FULL_RANGE'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '166.8', 'groupId': 'BG000', 'lowerLimit': '153', 'upperLimit': '189'}, {'value': '169.4', 'groupId': 'BG001', 'lowerLimit': '154', 'upperLimit': '179'}, {'value': '174.8', 'groupId': 'BG002', 'lowerLimit': '161', 'upperLimit': '185'}, {'value': '167.5', 'groupId': 'BG003', 'lowerLimit': '151', 'upperLimit': '191'}, {'value': '171.8', 'groupId': 'BG004', 'lowerLimit': '156', 'upperLimit': '186'}, {'value': '168.5', 'groupId': 'BG005', 'lowerLimit': '151', 'upperLimit': '184'}, {'value': '172.3', 'groupId': 'BG006', 'lowerLimit': '167', 'upperLimit': '175'}, {'value': '171.8', 'groupId': 'BG007', 'lowerLimit': '159', 'upperLimit': '182'}, {'value': '172.0', 'groupId': 'BG008', 'lowerLimit': '171', 'upperLimit': '173'}, {'value': '168.0', 'groupId': 'BG009', 'lowerLimit': '155', 'upperLimit': '180'}, {'value': '172.0', 'groupId': 'BG010', 'lowerLimit': '167', 'upperLimit': '177'}, {'value': '170.0', 'groupId': 'BG011', 'lowerLimit': '158', 'upperLimit': '181'}, {'value': '170.1', 'groupId': 'BG012', 'lowerLimit': '151', 'upperLimit': '191'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'FULL_RANGE'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '74.09', 'groupId': 'BG000', 'lowerLimit': '58.1', 'upperLimit': '98.7'}, {'value': '78.38', 'groupId': 'BG001', 'lowerLimit': '54.4', 'upperLimit': '95.7'}, {'value': '85.33', 'groupId': 'BG002', 'lowerLimit': '68.4', 'upperLimit': '100.4'}, {'value': '78.12', 'groupId': 'BG003', 'lowerLimit': '64.1', 'upperLimit': '92.9'}, {'value': '78.83', 'groupId': 'BG004', 'lowerLimit': '63.4', 'upperLimit': '97.0'}, {'value': '79.67', 'groupId': 'BG005', 'lowerLimit': '60.4', 'upperLimit': '98.2'}, {'value': '79.35', 'groupId': 'BG006', 'lowerLimit': '75.4', 'upperLimit': '82.5'}, {'value': '77.33', 'groupId': 'BG007', 'lowerLimit': '68.1', 'upperLimit': '87.5'}, {'value': '82.90', 'groupId': 'BG008', 'lowerLimit': '76.4', 'upperLimit': '92.4'}, {'value': '77.03', 'groupId': 'BG009', 'lowerLimit': '63.7', 'upperLimit': '90.1'}, {'value': '77.78', 'groupId': 'BG010', 'lowerLimit': '61.8', 'upperLimit': '88.9'}, {'value': '78.80', 'groupId': 'BG011', 'lowerLimit': '62.6', 'upperLimit': '101.4'}, {'value': '79.02', 'groupId': 'BG012', 'lowerLimit': '54.4', 'upperLimit': '101.4'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'All participants who received at least one dose of the study drug(s) were included in the safety set.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-21', 'size': 3246260, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-22T15:35', 'hasProtocol': True}, {'date': '2022-03-22', 'size': 1819195, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-22T15:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2022-03-10', 'resultsFirstSubmitDate': '2023-05-22', 'studyFirstSubmitQcDate': '2022-03-10', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-26', 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax: Maximum Observed Plasma Concentration for Soticlestat', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose'}, {'measure': 'AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose'}, {'measure': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From screening up to 14 days after the last dose of soticlestat (Day 51)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/30b7d725c12c42a5?idFilter=%5B%22TAK-935-1014%22%5D', 'label': 'To obtain more information on the study, click here/on this link'}]}, 'descriptionModule': {'briefSummary': 'The main aim is to see how soticlestat tablets of different strengths work and to compare how it works alone in contrast to administration along with food.\n\nIn the study will be 2 groups of participants (part A and part B). Participants in part A will receive 300 mg of soticlestat administered in different kind of tablets (regular tablets, mini-tablets, commercial tablets) and participant in part B will also receive 300 mg of soticlestat in tablets but with food and crushed tablets with applesauce.\n\nParticipants will complete several assessments including clinical laboratory evaluations, physical examinations, Columbia-Suicide Severity Rating Scale (C-SSRS) assessment, electrocardiographs (ECGs), and vital signs.', 'detailedDescription': 'The drug being tested in this study is called soticlestat (TAK-935). The study will assess the bioequivalence, effect of food and tablet crushing, safety and tolerability following single oral dose of 3 different soticlestat oral tablet formulations in healthy participants.\n\nThe study will enroll approximately 96 participants. This study will be conducted in two parts (Part A and Part B) having 6 treatment sequences each. Participants will be randomly assigned (by chance, like flipping a coin) to one of the study parts as per treatment sequence:\n\n* Part A, Sequence 1: Treatment A + Treatment B + Treatment C\n* Part A, Sequence 2: Treatment A + Treatment C + Treatment B\n* Part A, Sequence 3: Treatment B + Treatment A + Treatment C\n* Part A, Sequence 4: Treatment B + Treatment C + Treatment A\n* Part A, Sequence 5: Treatment C + Treatment A + Treatment B\n* Part A, Sequence 6: Treatment C + Treatment B + Treatment A\n* Part B, Sequence 1: Treatment D + Treatment E + Treatment F\n* Part B, Sequence 2: Treatment D + Treatment F + Treatment E\n* Part B, Sequence 3: Treatment E + Treatment D + Treatment F\n* Part B, Sequence 4: Treatment E + Treatment F + Treatment D\n* Part B, Sequence 5: Treatment F + Treatment D + Treatment E\n* Part B, Sequence 6: Treatment F + Treatment E + Treatment D\n\nThis single center trial will be conducted in the United States. The overall duration of the study is approximately 51 days. Participants will be followed up for 14 days after the last dose of study drug for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Body mass index (BMI) greater than or equal to (\\>=) 18.0 and less than or equal to (\\<=) 32.0 kilogram per square meter (kg/m\\^2) at screening.\n2. Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing.\n3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the Investigator or designee.\n4. Able to swallow multiple tablets.\n\nKey Exclusion Criteria:\n\n1. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.\n2. Positive urine drug or alcohol results at screening or check-in.\n3. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).\n4. Unable to refrain from or anticipates the use of:\n\n * Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to the first dosing.\n * Any drugs known to be significant inducers of cytochrome P450 (CYP) 3A, CYP2C19, uridine 5'-diphospho-glucuronosyltransferase (UGT) 1A9 or UGT2B4 enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, within 28 days prior to the first dosing. Appropriate sources will be consulted to confirm lack of PK/pharmacodynamics interaction with study drug.\n5. History of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer \\[354 milliliter per 12 ounce {mL/12 oz}\\], wine \\[118 mL/4 oz\\], or distilled spirits \\[29.5 mL/1 oz\\] per day).\n6. Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120mg of caffeine), of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.\n7. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.\n8. Donation of blood or significant blood loss within 56 days prior to the first dosing.\n9. Plasma donation within 7 days prior to the first dosing."}, 'identificationModule': {'nctId': 'NCT05284760', 'briefTitle': 'A Study of Soticlestat Tablets in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of Soticlestat Oral Tablet Formulations and the Effect of Food and Tablet Crushing on the Pharmacokinetics of Soticlestat in Healthy Adult Participants', 'orgStudyIdInfo': {'id': 'TAK-935-1014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A, Sequence 1: Treatment A + Treatment B + Treatment C', 'description': 'Soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment A, followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment B, and followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment C. A washout interval of exactly 4 days will be maintained between each Treatment Period.', 'interventionNames': ['Drug: Soticlestat']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Sequence 2: Treatment A + Treatment C + Treatment B', 'description': 'Soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment A, followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment C, and followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment B. A washout interval of exactly 4 days will be maintained between each Treatment Period.', 'interventionNames': ['Drug: Soticlestat']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Sequence 3: Treatment B + Treatment A + Treatment C', 'description': 'Soticlestat T3 mini-tablets 300 milligram (mg), orally, once on Day 1 of Period 1 under fasted condition as Treatment B, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment A, and followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment C. A washout interval of exactly 4 days will be maintained between each Treatment Period.', 'interventionNames': ['Drug: Soticlestat']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Sequence 4: Treatment B + Treatment C + Treatment A', 'description': 'Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment B, followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment C, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment A. A washout interval of exactly 4 days will be maintained between each Treatment Period.', 'interventionNames': ['Drug: Soticlestat']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Sequence 5: Treatment C + Treatment A + Treatment B', 'description': 'Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment C, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment A, and followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment B. A washout interval of exactly 4 days will be maintained between each Treatment Period.', 'interventionNames': ['Drug: Soticlestat']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Sequence 6: Treatment C + Treatment B + Treatment A', 'description': 'Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment C, followed by soticlestat T3 mini-tablets 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment B, and followed by soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment A. A washout interval of exactly 4 days will be maintained between each Treatment Period.', 'interventionNames': ['Drug: Soticlestat']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Sequence 1: Treatment D + Treatment E + Treatment F', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fasted condition as Treatment D, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fed condition as Treatment E, and followed by soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 3 under fasted condition as Treatment F. A washout interval of exactly 4 days will be maintained between each Treatment Period.', 'interventionNames': ['Drug: Soticlestat']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Sequence 2: Treatment D + Treatment F + Treatment E', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fasted condition as Treatment D, followed by soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 2 under fasted condition as Treatment F, and followed by soticlestat T4 300 mg, orally, once on Day 1 of Period 3 under fed condition as Treatment E. A washout interval of exactly 4 days will be maintained between each Treatment Period.', 'interventionNames': ['Drug: Soticlestat']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Sequence 3: Treatment E + Treatment D + Treatment F', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fed condition as Treatment E, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment D, and followed by soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 3 under fasted condition as Treatment F. A washout interval of exactly 4 days will be maintained between each Treatment Period.', 'interventionNames': ['Drug: Soticlestat']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Sequence 4: Treatment E + Treatment F + Treatment D', 'description': 'Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fed condition as Treatment E, followed by soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 2 under fasted condition as Treatment F, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment D. A washout interval of exactly 4 days will be maintained between each Treatment Period.', 'interventionNames': ['Drug: Soticlestat']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Sequence 5: Treatment F + Treatment D + Treatment E', 'description': 'Soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 1 under fasted condition as Treatment F, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment D, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fed condition as Treatment E. A washout interval of exactly 4 days will be maintained between each Treatment Period.', 'interventionNames': ['Drug: Soticlestat']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Sequence 3: Treatment F + Treatment E + Treatment D', 'description': 'Soticlestat T4 300 mg tablets, crushed and mixed with applesauce, orally, once on Day 1 of Period 1 under fasted condition as Treatment F, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fed condition as Treatment E, and followed by soticlestat T4 300 mg tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment D. A washout interval of exactly 4 days will be maintained between each Treatment Period.', 'interventionNames': ['Drug: Soticlestat']}], 'interventions': [{'name': 'Soticlestat', 'type': 'DRUG', 'otherNames': ['TAK-935'], 'description': 'Soticlestat T4 tablets.', 'armGroupLabels': ['Part A, Sequence 1: Treatment A + Treatment B + Treatment C', 'Part A, Sequence 2: Treatment A + Treatment C + Treatment B', 'Part A, Sequence 3: Treatment B + Treatment A + Treatment C', 'Part A, Sequence 4: Treatment B + Treatment C + Treatment A', 'Part A, Sequence 5: Treatment C + Treatment A + Treatment B', 'Part A, Sequence 6: Treatment C + Treatment B + Treatment A', 'Part B, Sequence 1: Treatment D + Treatment E + Treatment F', 'Part B, Sequence 2: Treatment D + Treatment F + Treatment E', 'Part B, Sequence 3: Treatment E + Treatment D + Treatment F', 'Part B, Sequence 3: Treatment F + Treatment E + Treatment D', 'Part B, Sequence 4: Treatment E + Treatment F + Treatment D', 'Part B, Sequence 5: Treatment F + Treatment D + Treatment E']}, {'name': 'Soticlestat', 'type': 'DRUG', 'otherNames': ['TAK-935'], 'description': 'Soticlestat T3 mini-tablets.', 'armGroupLabels': ['Part A, Sequence 1: Treatment A + Treatment B + Treatment C', 'Part A, Sequence 2: Treatment A + Treatment C + Treatment B', 'Part A, Sequence 3: Treatment B + Treatment A + Treatment C', 'Part A, Sequence 4: Treatment B + Treatment C + Treatment A', 'Part A, Sequence 5: Treatment C + Treatment A + Treatment B', 'Part A, Sequence 6: Treatment C + Treatment B + Treatment A', 'Part B, Sequence 1: Treatment D + Treatment E + Treatment F', 'Part B, Sequence 2: Treatment D + Treatment F + Treatment E', 'Part B, Sequence 3: Treatment E + Treatment D + Treatment F', 'Part B, Sequence 3: Treatment F + Treatment E + Treatment D', 'Part B, Sequence 4: Treatment E + Treatment F + Treatment D', 'Part B, Sequence 5: Treatment F + Treatment D + Treatment E']}, {'name': 'Soticlestat', 'type': 'DRUG', 'otherNames': ['TAK-935'], 'description': 'Soticlestat commercial tablets.', 'armGroupLabels': ['Part A, Sequence 1: Treatment A + Treatment B + Treatment C', 'Part A, Sequence 2: Treatment A + Treatment C + Treatment B', 'Part A, Sequence 3: Treatment B + Treatment A + Treatment C', 'Part A, Sequence 4: Treatment B + Treatment C + Treatment A', 'Part A, Sequence 5: Treatment C + Treatment A + Treatment B', 'Part A, Sequence 6: Treatment C + Treatment B + Treatment A', 'Part B, Sequence 1: Treatment D + Treatment E + Treatment F', 'Part B, Sequence 2: Treatment D + Treatment F + Treatment E', 'Part B, Sequence 3: Treatment E + Treatment D + Treatment F', 'Part B, Sequence 3: Treatment F + Treatment E + Treatment D', 'Part B, Sequence 4: Treatment E + Treatment F + Treatment D', 'Part B, Sequence 5: Treatment F + Treatment D + Treatment E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}