Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT05136404
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2021-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Relative Bioavailability Study of Selpercatinib (LY3527723) in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656166', 'term': 'selpercatinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '8005955979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 59 days', 'description': 'All enrolled participants who received at least one dose of selpercatinib, whether or not they completed all protocol requirements.', 'eventGroups': [{'id': 'EG000', 'title': 'Selpercatinib Sequence A:', 'description': 'Period 1: 20 milligram (mg) Selpercatinib capsule single oral dose administered orally on Day 1.\n\nPeriod 2: 20 mg per milliliter (mL) Selpercatinib Powder for Oral suspension (PFOS) single oral suspension dose on Day 8.\n\nPeriod 3: 20 mg/mL Selpercatinib Ready to Use (RTU) single oral suspension on Day 15.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Selpercatinib Sequence B:', 'description': 'Period 1: 20 mg/mL Selpercatinib RTU single oral suspension on Day 1.\n\nPeriod 2: 20 mg Selpercatinib capsule single oral dose administered orally on Day 8.\n\nPeriod 3: 20 mg/mL PFOS single oral suspension dose on Day 15.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Selpercatinib Sequence C:', 'description': 'Period 1: 20 mg/mL PFOS single oral suspension dose on Day 1.\n\nPeriod 2: 20 mg/mL Selpercatinib RTU single oral suspension on Day 8.\n\nPeriod 3: 20 mg Selpercatinib capsule single oral dose administered orally on Day 15.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '20 mg Selpercatinib Capsule (Reference)', 'description': '20 mg Selpercatinib capsule administered orally.'}, {'id': 'OG001', 'title': '20 mg Selpercatinib RTU Suspension (Test)', 'description': '20 mg/mL Selpercatinib RTU administered orally.'}, {'id': 'OG002', 'title': '20 mg/mL PFOS (Test)', 'description': '20 mg/mL PFOS administered orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '176', 'spread': '64.2', 'groupId': 'OG000'}, {'value': '174', 'spread': '36.9', 'groupId': 'OG001'}, {'value': '180', 'spread': '39.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.00', 'ciLowerLimit': '0.937', 'ciUpperLimit': '1.08', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Geometric Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.04', 'ciLowerLimit': '0.968', 'ciUpperLimit': '1.11', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1, 8, and 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours (h) postdose', 'description': 'PK: Cmax of Selpercatinib', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of Selpercatinib and have evaluable pharmacokinetic (PK) data.'}, {'type': 'PRIMARY', 'title': 'PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '20 mg Selpercatinib Capsule (Reference)', 'description': '20 mg Selpercatinib capsule administered orally.'}, {'id': 'OG001', 'title': '20 mg Selpercatinib RTU Suspension (Test)', 'description': '20 mg/mL Selpercatinib RTU administered orally.'}, {'id': 'OG002', 'title': '20 mg/mL PFOS (Test)', 'description': '20 mg/mL PFOS administered orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '2540', 'spread': '28.0', 'groupId': 'OG000'}, {'value': '2410', 'spread': '29.0', 'groupId': 'OG001'}, {'value': '2490', 'spread': '27.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.989', 'ciLowerLimit': '0.953', 'ciUpperLimit': '1.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Geometric Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.02', 'ciLowerLimit': '0.982', 'ciUpperLimit': '1.06', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1, 8, and 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 h postdose', 'description': 'PK AUC\\[0-∞\\] of Selpercatinib', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of selpercatinib and have evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '20 mg Selpercatinib Capsule (Reference)', 'description': '20 mg Selpercatinib capsule administered orally.'}, {'id': 'OG001', 'title': '20 mg Selpercatinib RTU Suspension (Test)', 'description': '20 mg/mL Selpercatinib RTU administered orally.'}, {'id': 'OG002', 'title': '20 mg/mL PFOS (Test)', 'description': '20 mg/mL PFOS administered orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '2180', 'spread': '36.9', 'groupId': 'OG000'}, {'value': '2160', 'spread': '31.6', 'groupId': 'OG001'}, {'value': '2190', 'spread': '30.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.01', 'ciLowerLimit': '0.972', 'ciUpperLimit': '1.06', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Geometric Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.03', 'ciLowerLimit': '0.992', 'ciUpperLimit': '1.08', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1, 8, and 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 h postdose', 'description': 'PK: AUC\\[0-tlast\\] of Selpercatinib', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Time to Maximum Observed Concentration (Tmax) of Selpercatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '20 mg Selpercatinib Capsule (Reference)', 'description': '20 mg Selpercatinib capsule administered orally.'}, {'id': 'OG001', 'title': '20 mg Selpercatinib RTU Suspension (Test)', 'description': '20 mg/mL Selpercatinib RTU administered orally.'}, {'id': 'OG002', 'title': '20 mg/mL PFOS (Test)', 'description': '20 mg/mL PFOS administered orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '24.02'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.50', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '3.50'}]}]}], 'analyses': [{'pValue': '0.4728', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.00', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.00', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0142', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.00', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.00', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1, 8, and 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 h postdose', 'description': 'PK: Tmax of Selpercatinib', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Selpercatinib Sequence A:', 'description': 'Period 1: 20 milligram (mg) Selpercatinib capsule single oral dose administered orally on Day 1.\n\nPeriod 2: 20 mg per milliliter (mL) Selpercatinib Powder for Oral suspension (PFOS) single oral suspension dose on Day 8.\n\nPeriod 3: 20 mg/mL Selpercatinib Ready to Use (RTU) single oral suspension on Day 15.\n\nSelpercatinib: Administered orally'}, {'id': 'FG001', 'title': 'Selpercatinib Sequence B', 'description': 'Period 1: 20 mg/mL Selpercatinib RTU single oral suspension on Day 1.\n\nPeriod 2: 20 mg Selpercatinib capsule single oral dose administered orally on Day 8.\n\nPeriod 3: 20 mg/mL PFOS single oral suspension dose on Day 15.\n\nSelpercatinib: Administered orally'}, {'id': 'FG002', 'title': 'Selpercatinib Sequence C', 'description': 'Period 1: 20 mg/mL PFOS single oral suspension dose on Day 1.\n\nPeriod 2: 20 mg/mL Selpercatinib RTU single oral suspension on Day 8.\n\nPeriod 3: 20 mg Selpercatinib capsule single oral dose administered orally on Day 15.\n\nSelpercatinib: Administered orally'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Received atLeast One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Inappropriate Behavior', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '20 mg Selpercatinib', 'description': 'Participants were randomized to 1 of 3 treatment sequences and will receive single doses of 20 mg Selpercatinib on each of Days 1, 8, and 15 as either the RTU suspension, the PFOS, or the capsule.\n\nSequence A: Period 1: 20 milligram (mg) Selpercatinib capsule single oral dose administered orally on Day 1. Period 2: 20 mg per milliliter (mL) Selpercatinib Powder for Oral suspension (PFOS) single oral suspension dose on Day 8. Period 3: 20 mg/mL Selpercatinib Ready to Use (RTU) single oral suspension on Day 15.\n\nSequence B: Period 1: 20 mg/mL Selpercatinib RTU single oral suspension on Day 1. Period 2: 20 mg Selpercatinib capsule single oral dose administered orally on Day 8. Period 3: 20 mg/mL PFOS single oral suspension dose on Day 15.\n\nSequence C: Period 1: 20 mg/mL PFOS single oral suspension dose on Day 1. Period 2: 20 mg/mL Selpercatinib RTU single oral suspension on Day 8. Period 3: 20 mg Selpercatinib capsule single oral dose administered orally on Day 15.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.0', 'spread': '9.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received at least one dose of Selpercatinib.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-22', 'size': 5283713, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-25T07:53', 'hasProtocol': True}, {'date': '2021-11-09', 'size': 2542328, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-25T07:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2021-11-25', 'resultsFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2021-11-25', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-27', 'studyFirstPostDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib', 'timeFrame': 'Days 1, 8, and 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours (h) postdose', 'description': 'PK: Cmax of Selpercatinib'}, {'measure': 'PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib', 'timeFrame': 'Days 1, 8, and 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 h postdose', 'description': 'PK AUC\\[0-∞\\] of Selpercatinib'}, {'measure': 'PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib', 'timeFrame': 'Days 1, 8, and 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 h postdose', 'description': 'PK: AUC\\[0-tlast\\] of Selpercatinib'}, {'measure': 'PK: Time to Maximum Observed Concentration (Tmax) of Selpercatinib', 'timeFrame': 'Days 1, 8, and 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 h postdose', 'description': 'PK: Tmax of Selpercatinib'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to compare the amount of selpercatinib that gets into the blood stream and how long it takes the body to get rid of it, when given as three different formulations in adult healthy participants. The information about any adverse effects experienced will be collected and the tolerability of selpercatinib will also be evaluated. The study may last up to 59 days including the 28 days of screening period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and vital signs\n* Body mass index (BMI) within the range 18.0 to 35.0 kilograms per meter squared (kg/m²)\n\nExclusion Criteria:\n\n* Have a history of allergic reactions to medications or food products\n* Have a clinically significant abnormality of blood pressure and/or pulse rate as determined by the investigator\n* Clinically significant abnormalities on ECG as determined by the investigator or prolongation of the QTcB or QTcF \\>450 msec at screening\n* Have clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to the planned start of selpercatinib\n* Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable\n* Use of H2 blockers, proton pump inhibitors, and other drugs that affect selpercatinib exposure within 7 days of screening\n* Are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen (≤2 g/24 hours), hormonal contraception, or hormone replacement therapy)'}, 'identificationModule': {'nctId': 'NCT05136404', 'briefTitle': 'A Relative Bioavailability Study of Selpercatinib (LY3527723) in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'An Open-Label, Randomized Study to Evaluate the Relative Bioavailability of Selpercatinib in 3 Formulations for Pediatric Use', 'orgStudyIdInfo': {'id': '17821'}, 'secondaryIdInfos': [{'id': 'J2G-MC-JZJU', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selpercatinib Sequence A:', 'description': 'Period 1: 20 milligram (mg) Selpercatinib capsule single oral dose administered orally on Day 1.\n\nPeriod 2: 20 mg per milliliter (mL) Selpercatinib Powder for Oral suspension (PFOS) single oral suspension dose on Day 8.\n\nPeriod 3: 20 mg/mL Selpercatinib Ready to Use (RTU) single oral suspension on Day 15.', 'interventionNames': ['Drug: Selpercatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Selpercatinib Sequence B', 'description': 'Period 1: 20 mg/mL Selpercatinib RTU single oral suspension on Day 1.\n\nPeriod 2: 20 mg Selpercatinib capsule single oral dose administered orally on Day 8.\n\nPeriod 3: 20 mg/mL PFOS single oral suspension dose on Day 15.', 'interventionNames': ['Drug: Selpercatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Selpercatinib Sequence C', 'description': 'Period 1: 20 mg/mL PFOS single oral suspension dose on Day 1.\n\nPeriod 2: 20 mg/mL Selpercatinib RTU single oral suspension on Day 8.\n\nPeriod 3: 20 mg Selpercatinib capsule single oral dose administered orally on Day 15.', 'interventionNames': ['Drug: Selpercatinib']}], 'interventions': [{'name': 'Selpercatinib', 'type': 'DRUG', 'otherNames': ['LY3527723', 'LOXO-292'], 'description': 'Administered orally', 'armGroupLabels': ['Selpercatinib Sequence A:', 'Selpercatinib Sequence B', 'Selpercatinib Sequence C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'LabCorp CRU, Inc.', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loxo Oncology, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}