Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-04 @ 11:56 PM
Study NCT ID:
NCT03706469
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2018-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@neurocrine.com', 'phone': '877-641-3461', 'title': 'Neurocrine Medical Information', 'organization': 'Neurocrine Biosciences'}, 'certainAgreement': {'otherDetails': 'Generally, the PI may publish results of the study following the publication of results by the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 post dose up to 14 days after the last dose of study drug ( Up to Day 47).', 'description': 'At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. 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': 'TAK-831 T2 50 mg Fasted', 'description': 'TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TAK-831 T3 50 mg Fasted', 'description': 'TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'TAK-831 T2 600 mg Fasted', 'description': 'TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'TAK-831 T3 600 mg Fasted', 'description': 'TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'TAK-831 T3 600 mg Fed', 'description': 'TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-831 T2 50 mg Fasted', 'description': 'TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG001', 'title': 'TAK-831 T3 50 mg Fasted', 'description': 'TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG002', 'title': 'TAK-831 T2 600 mg Fasted', 'description': 'TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG003', 'title': 'TAK-831 T3 600 mg Fasted', 'description': 'TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG004', 'title': 'TAK-831 T3 600 mg Fed', 'description': 'TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '714.8', 'spread': '28.7', 'groupId': 'OG000'}, {'value': '597.5', 'spread': '37.0', 'groupId': 'OG001'}, {'value': '4563', 'spread': '24.8', 'groupId': 'OG002'}, {'value': '4665', 'spread': '41.8', 'groupId': 'OG003'}, {'value': '8058', 'spread': '29.0', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage of Geometric Mean Ratio (GMR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '83.60', 'ciLowerLimit': '74.50', 'ciUpperLimit': '93.80', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence in the AUClast will be concluded if the 90 percent (%) confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Percentage of GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.22', 'ciLowerLimit': '91.10', 'ciUpperLimit': '114.70', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Percentage of GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '172.73', 'ciLowerLimit': '152.55', 'ciUpperLimit': '195.58', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose', 'unitOfMeasure': 'nanogram*hour per milliliter(ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.'}, {'type': 'PRIMARY', 'title': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-831 T2 50 mg Fasted', 'description': 'TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG001', 'title': 'TAK-831 T3 50 mg Fasted', 'description': 'TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG002', 'title': 'TAK-831 T2 600 mg Fasted', 'description': 'TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG003', 'title': 'TAK-831 T3 600 mg Fasted', 'description': 'TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG004', 'title': 'TAK-831 T3 600 mg Fed', 'description': 'TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '761.8', 'spread': '29.3', 'groupId': 'OG000'}, {'value': '688.6', 'spread': '31.0', 'groupId': 'OG001'}, {'value': '4665', 'spread': '26.0', 'groupId': 'OG002'}, {'value': '4558', 'spread': '41.8', 'groupId': 'OG003'}, {'value': '7934', 'spread': '27.3', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage of GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '84.29', 'ciLowerLimit': '73.92', 'ciUpperLimit': '96.11', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Percentage of GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.61', 'ciLowerLimit': '88.88', 'ciUpperLimit': '111.63', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Percentage of GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '172.70', 'ciLowerLimit': '149.07', 'ciUpperLimit': '200.09', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration. The PK analysis population where data at specified time points were available.'}, {'type': 'PRIMARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for TAK-831', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-831 T2 50 mg Fasted', 'description': 'TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG001', 'title': 'TAK-831 T3 50 mg Fasted', 'description': 'TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG002', 'title': 'TAK-831 T2 600 mg Fasted', 'description': 'TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG003', 'title': 'TAK-831 T3 600 mg Fasted', 'description': 'TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG004', 'title': 'TAK-831 T3 600 mg Fed', 'description': 'TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '397.5', 'spread': '38.8', 'groupId': 'OG000'}, {'value': '314.6', 'spread': '40.0', 'groupId': 'OG001'}, {'value': '1384', 'spread': '28.9', 'groupId': 'OG002'}, {'value': '1381', 'spread': '24.6', 'groupId': 'OG003'}, {'value': '2394', 'spread': '37.1', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage of GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '79.14', 'ciLowerLimit': '67.36', 'ciUpperLimit': '92.99', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Percentage of GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.80', 'ciLowerLimit': '84.94', 'ciUpperLimit': '117.27', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Percentage of GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '173.30', 'ciLowerLimit': '150.05', 'ciUpperLimit': '200.16', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-831 T2 50 mg Fasted', 'description': 'TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG001', 'title': 'TAK-831 T3 50 mg Fasted', 'description': 'TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG002', 'title': 'TAK-831 T2 600 mg Fasted', 'description': 'TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG003', 'title': 'TAK-831 T3 600 mg Fasted', 'description': 'TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.'}, {'id': 'OG004', 'title': 'TAK-831 T3 600 mg Fed', 'description': 'TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 post dose up to 14 days after the last dose of study drug (Up to Day 47)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who received at least one dose of the study drug(s).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg)', 'description': 'TAK-831 T2 50 milligram (mg), tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.'}, {'id': 'FG001', 'title': 'Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg)', 'description': 'TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.'}, {'id': 'FG002', 'title': 'Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg)', 'description': 'TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.'}, {'id': 'FG003', 'title': 'Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg)', 'description': 'TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 1 investigative site in the United States from 18 October 2018 to 22 December 2018.', 'preAssignmentDetails': 'Healthy participants were enrolled and randomized in one of the 4 treatment sequences to receive TAK-831.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg)', 'description': 'TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.'}, {'id': 'BG001', 'title': 'Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg)', 'description': 'TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.'}, {'id': 'BG002', 'title': 'Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg)', 'description': 'TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.'}, {'id': 'BG003', 'title': 'Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg)', 'description': 'TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.3', 'spread': '10.94', 'groupId': 'BG000'}, {'value': '49.0', 'spread': '8.49', 'groupId': 'BG001'}, {'value': '31.8', 'spread': '9.22', 'groupId': 'BG002'}, {'value': '30.0', 'spread': '9.56', 'groupId': 'BG003'}, {'value': '37.8', 'spread': '11.60', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'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'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'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'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '80.48', 'spread': '9.694', 'groupId': 'BG000'}, {'value': '67.55', 'spread': '6.815', 'groupId': 'BG001'}, {'value': '70.63', 'spread': '19.643', 'groupId': 'BG002'}, {'value': '76.07', 'spread': '4.666', 'groupId': 'BG003'}, {'value': '73.68', 'spread': '11.660', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram (Kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '175.3', 'spread': '5.74', 'groupId': 'BG000'}, {'value': '168.3', 'spread': '6.65', 'groupId': 'BG001'}, {'value': '169.5', 'spread': '13.48', 'groupId': 'BG002'}, {'value': '169.3', 'spread': '2.06', 'groupId': 'BG003'}, {'value': '170.6', 'spread': '7.79', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.060', 'spread': '1.6219', 'groupId': 'BG000'}, {'value': '24.090', 'spread': '4.1222', 'groupId': 'BG001'}, {'value': '24.250', 'spread': '3.3966', 'groupId': 'BG002'}, {'value': '26.620', 'spread': '1.9483', 'groupId': 'BG003'}, {'value': '25.255', 'spread': '2.8796', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The safety analysis set included all participants who received at least one dose of the study drug(s).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-28', 'size': 3794828, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-12-02T15:24', 'hasProtocol': True}, {'date': '2018-12-19', 'size': 1992298, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-12-02T15:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2018-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-09', 'studyFirstSubmitDate': '2018-10-11', 'resultsFirstSubmitDate': '2019-12-02', 'studyFirstSubmitQcDate': '2018-10-11', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-02', 'studyFirstPostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose'}, {'measure': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose'}, {'measure': 'Cmax: Maximum Observed Plasma Concentration for TAK-831', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)', 'timeFrame': 'Day 1 post dose up to 14 days after the last dose of study drug (Up to Day 47)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the oral BA of TAK-831 T3 tablet formulation relative to TAK-831 T2 tablet formulation under fasting conditions and to assess the effect of food on the pharmacokinetics (PK) of TAK-831 T3 tablet formulation.', 'detailedDescription': 'The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy participants to evaluate the relative BA and effect of food on the PK of TAK-831 tablet formulation.\n\nThe study will enroll approximately 16 participants. Participants will be randomly assigned (by chance, like flipping a coin) to TAK-831 in 1 of the 4 treatment sequences as following:\n\n* T2 50 mg Fasted + T3 50 mg Fasted + T3 600 mg Fasted + T2 600 mg Fasted + T3 600 mg Fed\n* T3 50 mg Fasted + T2 600 mg Fasted + T2 50 mg Fasted + T3 600 mg Fasted + T3 600 mg Fed\n* T2 600 mg Fasted + T3 600 mg Fasted + T3 50 mg Fasted + T2 50 mg Fasted + T3 600 mg Fed\n* T3 600 mg Fasted + T2 50 mg Fasted + T2 600 mg Fasted + T3 50 mg Fasted + T3 600 mg Fed\n\nAll participants will be asked to take tablet of assigned TAK-831 on Day 1 of each treatment period.\n\nThis single center trial will be conducted in the United States. The overall time to participate in this study is approximately 70 days. Participants will make multiple visits to the clinic and will be contacted by clinic approximately 14 days after the last dose of study drug for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Body mass index (BMI) greater than or equal to (\\>=) 18.0 and less than (\\<) 30.0 kilogram per square meter (kg/m\\^2), at Screening.\n\nExclusion Criteria:\n\n1. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.\n2. Smokes more than 20 cigarettes or equivalent per day within 3 months prior to the first dose and is unwilling to discontinue use of any tobacco- or nicotine-containing products during the confinement period(s) of the study.\n3. 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.\n4. Is lactose intolerant or unable/unwilling to eat the high-fat breakfast.\n5. Donation of blood or significant blood loss within 56 days prior to the first dosing.'}, 'identificationModule': {'nctId': 'NCT03706469', 'briefTitle': 'A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurocrine Biosciences'}, 'officialTitle': 'A Phase 1, Open-Label, Randomized, Single Dose, 5-Period, 5-Treatment Study to Evaluate the Relative Bioavailability and Effect of Food on TAK-831 Tablet Formulations in Healthy Subjects', 'orgStudyIdInfo': {'id': 'TAK-831-1006'}, 'secondaryIdInfos': [{'id': 'U1111-1217-5483', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg)', 'description': 'TAK-831 T2 50 milligram (mg), tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods.', 'interventionNames': ['Drug: TAK-831 T2', 'Drug: TAK-831 T3']}, {'type': 'EXPERIMENTAL', 'label': 'Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg)', 'description': 'TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods.', 'interventionNames': ['Drug: TAK-831 T2', 'Drug: TAK-831 T3']}, {'type': 'EXPERIMENTAL', 'label': 'Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg)', 'description': 'TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods.', 'interventionNames': ['Drug: TAK-831 T2', 'Drug: TAK-831 T3']}, {'type': 'EXPERIMENTAL', 'label': 'Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg)', 'description': 'TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods.', 'interventionNames': ['Drug: TAK-831 T2', 'Drug: TAK-831 T3']}], 'interventions': [{'name': 'TAK-831 T2', 'type': 'DRUG', 'description': 'TAK-831 T2 Tablets.', 'armGroupLabels': ['Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg)', 'Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg)', 'Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg)', 'Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg)']}, {'name': 'TAK-831 T3', 'type': 'DRUG', 'description': 'TAK-831 T3 Tablets.', 'armGroupLabels': ['Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg)', 'Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg)', 'Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg)', 'Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurocrine Biosciences', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}