Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-03-03 @ 12:38 AM
Study NCT ID:
NCT02917733
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2016-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Absorption, Distribution, Metabolism and Excretion of LY3039478 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654634', 'term': 'crenigacestat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'All the participants who received the \\[14C2\\]-LY3039478 dose.', 'eventGroups': [{'id': 'EG000', 'title': '75 mg [14C2] LY3039478', 'description': 'All the participants received approximately 75 mg \\[14C2\\] LY3039478 containing approximately 100 μCi \\[14C2\\] LY3039478, with the exception of participant 01005 who received a lower than expected dose (84.5249 µCi, rather than the target dose of 100 µCi).', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Urinary and Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg [14C2] LY3039478', 'description': 'Participants received approximately 75 mg \\[14C2\\] LY3039478 containing approximately 100 μCi \\[14C2\\] LY3039478.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.2', 'spread': '2.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312 hours postdose', 'description': 'To determine the disposition of radioactivity and LY3039478 in healthy participants following oral administration of a single dose 14C-labeled LY3039478.', 'unitOfMeasure': 'percentage of administered radioactivity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the \\[14C2\\]-LY3039478 dose.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3039478', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg [14C2] LY3039478', 'description': 'Participants received approximately 75 mg \\[14C2\\] LY3039478 containing approximately 100 μCi \\[14C2\\] LY3039478.'}], 'classes': [{'categories': [{'measurements': [{'value': '2570', 'spread': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose', 'description': 'The AUC\\[0-inf\\]) for plasma LY3039478 was evaluated by using a combination of the linear and logarithmic trapezoidal methods (linear-log trapezoidal rule).', 'unitOfMeasure': 'nanograms*hour/milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the participants who received \\[14C2\\]-LY3039478 dose and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Total Plasma Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg [14C2] LY3039478', 'description': 'Participants received approximately 75 mg \\[14C2\\] LY3039478 containing approximately 100 μCi \\[14C2\\] LY3039478.'}], 'classes': [{'categories': [{'measurements': [{'value': '26100', 'spread': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose', 'description': 'The AUC\\[0-inf\\]) for total plasma radioactivity was evaluated by using a combination of the linear and logarithmic trapezoidal methods (linear-log trapezoidal rule).', 'unitOfMeasure': 'ng quivalents*hour/gram (ng equiv.h/g)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the participants who received \\[14C2\\]-LY3039478 dose and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Maximum Observed Concentration (Cmax) of LY3039478', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg [14C2] LY3039478', 'description': 'Participants received approximately 75 mg \\[14C2\\] LY3039478 containing approximately 100 μCi \\[14C2\\] LY3039478.'}], 'classes': [{'categories': [{'measurements': [{'value': '517', 'spread': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose', 'description': 'The Cmax of LY3039478 was evaluated.', 'unitOfMeasure': 'Nanograms/milliliter (ng/ml)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the participants who received \\[14C2\\]-LY3039478 dose and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Maximum Observed Concentration (Cmax) of Total Plasma Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg [14C2] LY3039478', 'description': 'Participants received approximately 75 mg \\[14C2\\] LY3039478 containing approximately 100 μCi \\[14C2\\] LY3039478.'}], 'classes': [{'categories': [{'measurements': [{'value': '1060', 'spread': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose', 'description': 'Cmax of total plasma radioactivity was evaluated.', 'unitOfMeasure': 'Nanograms equivalents/gram (ng equiv/g)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received \\[14C2\\]-LY3039478 dose and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Total Number of Metabolites of LY3039478 in Plasma, Urine and Feces', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg [14C2] LY3039478', 'description': 'Participants received approximately 75 mg \\[14C2\\] LY3039478 containing approximately 100 μCi \\[14C2\\] LY3039478.'}], 'classes': [{'title': 'Number of Metabolites of LY3039478 in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Number of Metabolites of LY3039478 in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Number of Metabolites of LY3039478 in Feces', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose.', 'description': 'Following oral administration, radio high performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS) profiles were obtained from analysis of plasma, urine and feces.', 'unitOfMeasure': 'Metabolites', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received \\[14C2\\]-LY3039478 dose. For the feces profiling, only one participant had quantifiable radioactive dose recovered in feces adequate for metabolite profiling and was therefore eligible for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '75 mg [14C2] LY3039478', 'description': 'Participants received approximately 75 mg \\[14C2\\] LY3039478 containing approximately 100 μCi \\[14C2\\] LY3039478.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '75 mg [14C2] LY3039478', 'description': 'Participants received approximately 75 mg \\[14C2\\] LY3039478 containing approximately 100 μCi \\[14C2\\] LY3039478.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.0', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', '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': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received the \\[14C2\\]-LY3039478 dose.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2016-09-15', 'resultsFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2016-09-26', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-09', 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary and Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered', 'timeFrame': 'Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312 hours postdose', 'description': 'To determine the disposition of radioactivity and LY3039478 in healthy participants following oral administration of a single dose 14C-labeled LY3039478.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3039478', 'timeFrame': 'Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose', 'description': 'The AUC\\[0-inf\\]) for plasma LY3039478 was evaluated by using a combination of the linear and logarithmic trapezoidal methods (linear-log trapezoidal rule).'}, {'measure': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Total Plasma Radioactivity', 'timeFrame': 'Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose', 'description': 'The AUC\\[0-inf\\]) for total plasma radioactivity was evaluated by using a combination of the linear and logarithmic trapezoidal methods (linear-log trapezoidal rule).'}, {'measure': 'Pharmacokinetics: Maximum Observed Concentration (Cmax) of LY3039478', 'timeFrame': 'Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose', 'description': 'The Cmax of LY3039478 was evaluated.'}, {'measure': 'Pharmacokinetics: Maximum Observed Concentration (Cmax) of Total Plasma Radioactivity', 'timeFrame': 'Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose', 'description': 'Cmax of total plasma radioactivity was evaluated.'}, {'measure': 'Total Number of Metabolites of LY3039478 in Plasma, Urine and Feces', 'timeFrame': 'Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose.', 'description': 'Following oral administration, radio high performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS) profiles were obtained from analysis of plasma, urine and feces.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This type of study is called a radiolabeled study. For this study, LY3039478 (study drug) has been specially prepared to contain radiolabeled carbon \\[¹⁴C\\]. \\[¹⁴C\\] is a naturally occurring radioactive form of the element carbon. This study will help determine how the drug appears in the blood, urine, and stool after it is administered by mouth to healthy people. Information about any side effects that may occur will also be collected. This study will last about 10 weeks for each participant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m²), inclusive\n\nExclusion Criteria:\n\n* Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product\n* Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy\n* Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)\n* Have participated in a \\[¹⁴C\\] study within the last 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of one other previous \\[¹⁴C\\]-study within 6 to 12 months of this study must be within the Code of Federal Regulations (CFR) recommended levels considered safe: less than 5000 millirem (mrem)/year whole body annual exposure'}, 'identificationModule': {'nctId': 'NCT02917733', 'briefTitle': 'A Study of the Absorption, Distribution, Metabolism and Excretion of LY3039478 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Disposition of [¹⁴C₂]-Labeled LY3039478 Following Oral Administration in Healthy Subjects', 'orgStudyIdInfo': {'id': '16343'}, 'secondaryIdInfos': [{'id': 'I6F-MC-JJCF', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiolabelled LY3039478', 'description': 'Single dose of radiolabelled LY3039478 administered orally.', 'interventionNames': ['Drug: LY3039478']}], 'interventions': [{'name': 'LY3039478', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Radiolabelled LY3039478']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Covance Clinical Research Inc', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}