Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-05 @ 1:30 PM
Study NCT ID:
NCT03101293
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2017-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet Formulation
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': 'Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug (up to Day 23)', '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': 'TAK-831 400 mg Fasted', 'description': 'TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of either Intervention Period 1 or Intervention Period 2.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TAK-831 400 mg Fed', 'description': 'TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1 or Intervention Period 2.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for TAK-831', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-831 400 mg Fasted', 'description': 'TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of either Intervention Period 1 or Intervention Period 2.'}, {'id': 'OG001', 'title': 'TAK-831 400 mg Fed', 'description': 'TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1 or Intervention Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '650.04', 'spread': '47.7', 'groupId': 'OG000'}, {'value': '865.48', 'spread': '53.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.343', 'ciLowerLimit': '1.146', 'ciUpperLimit': '1.574', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% confidence intervals (CIs).'}], '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 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': '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': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-831 400 mg Fasted', 'description': 'TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of either Intervention Period 1 or Intervention Period 2.'}, {'id': 'OG001', 'title': 'TAK-831 400 mg Fed', 'description': 'TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1 or Intervention Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2290.8', 'spread': '53.1', 'groupId': 'OG000'}, {'value': '2535.6', 'spread': '58.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1763', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.121', 'ciLowerLimit': '0.969', 'ciUpperLimit': '1.298', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% CIs.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose', 'unitOfMeasure': 'hour*nanogram per milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The 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': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-831 400 mg Fasted', 'description': 'TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of either Intervention Period 1 or Intervention Period 2.'}, {'id': 'OG001', 'title': 'TAK-831 400 mg Fed', 'description': 'TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1 or Intervention Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2194.8', 'spread': '53.1', 'groupId': 'OG000'}, {'value': '2465.9', 'spread': '67.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2745', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.154', 'ciLowerLimit': '0.929', 'ciUpperLimit': '1.433', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% CIs.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The 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': 'SECONDARY', 'title': 'Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-831 400 mg Fasted', 'description': 'TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of either Intervention Period 1 or Intervention Period 2.'}, {'id': 'OG001', 'title': 'TAK-831 400 mg Fed', 'description': 'TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1 or Intervention Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAK-831 400 mg Fasted + TAK-831 400 mg Fed', 'description': 'TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fed state, once on Day 1 of Intervention Period 2.'}, {'id': 'FG001', 'title': 'TAK-831 400 mg Fed + TAK-831 400 mg Fasted', 'description': 'TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fasted state, once on Day 1 of Intervention Period 2.'}], 'periods': [{'title': 'Intervention Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period (at Least 7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Positive drug urine screen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Intervention Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 1 investigative site in the United States from 04 April 2017 to 26 May 2017.', 'preAssignmentDetails': 'Healthy participants were enrolled in this 2-way crossover study and randomized in 1 of the 2 treatment sequences which determined the order to receive TAK-831 400 milligram (mg) film-coated tablets under fasted conditions and TAK-831 400 mg tablet under fed conditions (nutritional drink).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TAK-831 400 mg Fasted + TAK-831 400 mg Fed', 'description': 'TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fed state, once on Day 1 of Intervention Period 2.'}, {'id': 'BG001', 'title': 'TAK-831 400 mg Fed + TAK-831 400 mg Fasted', 'description': 'TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fasted state, once on Day 1 of Intervention Period 2.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'spread': '7.98', 'groupId': 'BG000'}, {'value': '32.6', 'spread': '11.22', 'groupId': 'BG001'}, {'value': '33.9', 'spread': '9.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}, {'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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'spread': '9.65', 'groupId': 'BG000'}, {'value': '78.6', 'spread': '11.19', 'groupId': 'BG001'}, {'value': '76.1', 'spread': '10.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '171.3', 'spread': '6.40', 'groupId': 'BG000'}, {'value': '173.8', 'spread': '7.19', 'groupId': 'BG001'}, {'value': '172.6', 'spread': '6.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '24.9', 'spread': '2.17', 'groupId': 'BG000'}, {'value': '25.9', 'spread': '2.45', 'groupId': 'BG001'}, {'value': '25.5', 'spread': '2.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}, {'title': 'Smoking Classification', 'classes': [{'categories': [{'title': 'Never smoked', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Current smoker', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Ex-smoker', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}, {'title': 'Alcohol Classification', 'classes': [{'categories': [{'title': 'Never drunk', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Current drinker', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Ex-drinker', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}, {'title': 'Caffeine Consumption', 'classes': [{'categories': [{'title': 'Caffeine consumption', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'No caffeine consumption', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}, {'title': 'Xanthine Consumption', 'classes': [{'categories': [{'title': 'Xanthine consumption', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'No xanthine consumption', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}, {'title': 'Female Reproductive Status', 'classes': [{'categories': [{'title': 'Post-menopausal', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Surgically sterile', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not applicable (Male)', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}], 'populationDescription': 'The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-11', 'size': 933193, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-10T08:54', 'hasProtocol': True}, {'date': '2017-06-09', 'size': 620964, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-10T08:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-09', 'studyFirstSubmitDate': '2017-03-28', 'resultsFirstSubmitDate': '2018-05-10', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-15', 'studyFirstPostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}, {'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'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy participants.', 'detailedDescription': 'The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy participants under fasting and fed conditions in order to determine the effect of food on the PK of single oral dose of TAK-831 tablet formulation. The study will enroll approximately 16 participants. Participants will be randomly and equally assigned (by chance, like flipping a coin) to 1 of the 2 treatment sequences following as:\n\n* TAK-831 400 mg Fasted + TAK-831 400 mg Fed\n* TAK-831 400 mg Fed + TAK-831 400 mg Fasted All participants will be asked to take single oral dose of TAK-831 tablet at the same time on Day 1 of each Intervention Period. This single center trial will be conducted in the United States. The overall time to participate in this study is 23 days. Participants will visit the clinic on Day -1 and remained confined until Day 3 of Intervention Period 1 and 2. A washout period of minimum 7 days will be maintained between the doses in each Intervention Period. Participants will make 3 visits to the clinic on Days 4, 6 and 8 on each Intervention Period and will be contacted by telephone 14 days after the last dose of study drug (Day 23) for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Weighs greater than or equal to (\\>=) 45 kilogram (kg) and has a body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m\\^2), inclusive at Screening.\n\nExclusion Criteria:\n\n1. Has received TAK-831 in a previous clinical study.\n2. Has poor peripheral venous access.\n3. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to first dose of study drug.\n4. Has any dietary restrictions or preferences that may interfere with the conduct of the study.'}, 'identificationModule': {'nctId': 'NCT03101293', 'briefTitle': 'A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet Formulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurocrine Biosciences'}, 'officialTitle': 'A Randomized, Open-Label, Single-Dose, 2-Period, Crossover Design, Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 T2 Tablet Formulation in Healthy Subjects', 'orgStudyIdInfo': {'id': 'TAK-831-1004'}, 'secondaryIdInfos': [{'id': 'U1111-1189-8001', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAK-831 400 mg Fasted + TAK-831 400 mg Fed', 'description': 'TAK-831 400 mg, film-coated tablets, orally under fasted state, once on Day 1 of Intervention Period 1, followed by 7 days washout period, further followed by TAK-831 400 mg, film-coated tablets, orally under fed state, once on Day 1 of Intervention Period 2.', 'interventionNames': ['Drug: TAK-831']}, {'type': 'EXPERIMENTAL', 'label': 'TAK-831 400 mg Fed + TAK-831 400 mg Fasted', 'description': 'TAK-831 400 mg, film-coated tablets, orally under fed state, once on Day 1 of Intervention Period 1, followed by 7 days washout period, further followed by TAK-831 400 mg, film-coated tablets, orally under fasted state, once on Day 1 of Intervention Period 2.', 'interventionNames': ['Drug: TAK-831']}], 'interventions': [{'name': 'TAK-831', 'type': 'DRUG', 'description': 'TAK-831 film-coated tablet.', 'armGroupLabels': ['TAK-831 400 mg Fasted + TAK-831 400 mg Fed', 'TAK-831 400 mg Fed + TAK-831 400 mg Fasted']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'PRA Health Sciences', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurocrine Biosciences', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}