{"protocolSection":{"identificationModule":{"nctId":"NCT04311424","orgStudyIdInfo":{"id":"17378"},"secondaryIdInfos":[{"id":"I8F-MC-GPHX","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2019-003664-44","type":"EUDRACT_NUMBER"},{"id":"2019","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2019"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"Study of Tirzepatide in Healthy Participants","officialTitle":"Disposition of [14C]-Tirzepatide Following Subcutaneous Administration in Healthy Male Subjects"},"statusModule":{"statusVerifiedDate":"2022-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-07-28","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-10-02","type":"ACTUAL"},"completionDateStruct":{"date":"2020-10-02","type":"ACTUAL"},"studyFirstSubmitDate":"2020-03-16","studyFirstSubmitQcDate":"2020-03-16","studyFirstPostDateStruct":{"date":"2020-03-17","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-06-09","resultsFirstSubmitQcDate":"2022-06-09","resultsFirstPostDateStruct":{"date":"2023-03-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-06-09","lastUpdatePostDateStruct":{"date":"2023-03-24","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"The purpose of this study is to look at how much tirzepatide gets into the bloodstream and how long the body takes to get rid of it. This study will involve a single dose of 14C radiolabelled tirzepatide. This means that a radioactive tracer substance, C14, will be incorporated into the study drug to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine, feces and expired air.\n\nScreening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 15 weeks, including screening."},"conditionsModule":{"conditions":["Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":6,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"14C Tirzepatide","type":"EXPERIMENTAL","description":"A single dose of \\[14C\\]-tirzepatide administered subcutaneously (SC).","interventionNames":["Drug: 14C Tirzepatide"]}],"interventions":[{"type":"DRUG","name":"14C Tirzepatide","description":"Administered SC.","armGroupLabels":["14C Tirzepatide"],"otherNames":["LY3298176"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered","description":"Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered.","timeFrame":"Pre-dose and up to 63 days post-dose"},{"measure":"Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered","description":"Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered.","timeFrame":"Pre-dose and up to 63 days post-dose"}],"secondaryOutcomes":[{"measure":"Total Number of Metabolites","description":"Total Number of Metabolites.","timeFrame":"Pre-dose and up to 63 days post-dose"},{"measure":"Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable)","description":"Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable).","timeFrame":"Pre-dose and up to 63 days post-dose"},{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Tirzepatide","description":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC\\[0-∞\\]) of tirzepatide.","timeFrame":"Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose"},{"measure":"PK: Maximum Concentration (Cmax) of Tirzepatide","description":"PK: Maximum Concentration (Cmax) of tirzepatide.","timeFrame":"Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose"},{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Total Radioactivity","description":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC\\[0-∞\\]) of Total Radioactivity. Total radioactivity is reported as hours\\*nanogram equivalents per milliliter (h\\*ng Eq/mL).","timeFrame":"Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose"},{"measure":"PK: Maximum Concentration (Cmax) of Total Radioactivity","description":"PK: Cmax of total radioactivity in plasma and whole blood. The Cmax of total radioactivity in plasma and whole blood are reported as nanogram equivalents per milliliter (ng Eq/mL).","timeFrame":"Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Overtly healthy males as determined by medical history, physical examination, and other screening procedures\n* Have a body mass index (BMI) between 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive at screening\n* Are willing to be available for the full duration of the study\n\nExclusion Criteria:\n\n* Have known allergies to tirzepatide or related compounds\n* Have a medical condition or medical history that makes participation in the study unsafe or which may interfere in the interpretation of the results of the study\n* Have had exposure to significant radiation within 12 months prior to dosing (for example, multiple x-ray or computed tomography \\[CT\\] scans, barium meal, being employed in a job requiring radiation exposure monitoring)\n* Have participated in any clinical trial involving a radiolabeled substance within the past 12 months","healthyVolunteers":true,"sex":"MALE","minimumAge":"30 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"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)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Covance Clinical Research Ltd","city":"Leeds","state":"West Yorkshire","zip":"LS2 9LH","country":"United Kingdom","geoPoint":{"lat":53.79648,"lon":-1.54785}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"[14C]-Tirzepatide","description":"Participants received single dose of approximately 4.1 milligrams (mg) tirzepatide containing approximately 100 microcurie (μCi) of \\[14C\\]- tirzepatide administered as a subcutaneous injection."}],"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":{"populationDescription":"All randomized participants.","groups":[{"id":"BG000","title":"[14C]-Tirzepatide","description":"Participants received single dose of approximately 4.1 mg tirzepatide containing approximately 100 μCi of \\[14C\\]- tirzepatide administered as a subcutaneous injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"6"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"41.0","spread":"10.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"6"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"6"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"6"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"United Kingdom","categories":[{"measurements":[{"groupId":"BG000","value":"6"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered","description":"Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered.","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of the total radioactive dose","timeFrame":"Pre-dose and up to 63 days post-dose","groups":[{"id":"OG000","title":"[14C]-Tirzepatide","description":"Participants received single dose of approximately 4.1 mg tirzepatide containing approximately 100 μCi of \\[14C\\]- tirzepatide administered as a subcutaneous injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"49.56","spread":"2.58"}]}]}]},{"type":"PRIMARY","title":"Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered","description":"Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered.","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of the total radioactive dose","timeFrame":"Pre-dose and up to 63 days post-dose","groups":[{"id":"OG000","title":"[14C]-Tirzepatide","description":"Participants received single dose of approximately 4.1 mg tirzepatide containing approximately 100 μCi of \\[14C\\]- tirzepatide administered as a subcutaneous injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20.46","spread":"2.05"}]}]}]},{"type":"SECONDARY","title":"Total Number of Metabolites","description":"Total Number of Metabolites.","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"metabolites","timeFrame":"Pre-dose and up to 63 days post-dose","groups":[{"id":"OG000","title":"[14C]-Tirzepatide","description":"Participants received single dose of approximately 4.1 mg tirzepatide containing approximately 100 μCi of \\[14C\\]- tirzepatide administered as a subcutaneous injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"}]}],"classes":[{"title":"Plasma","categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]},{"title":"Urine","categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]},{"title":"Feces","categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]}]},{"type":"SECONDARY","title":"Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable)","description":"Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable).","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of the total radioactive dose","timeFrame":"Pre-dose and up to 63 days post-dose","groups":[{"id":"OG000","title":"[14C]-Tirzepatide","description":"Participants received single dose of approximately 4.1 mg tirzepatide containing approximately 100 μCi of \\[14C\\]- tirzepatide administered as a subcutaneous injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"70.03","spread":"1.98"}]}]}]},{"type":"SECONDARY","title":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Tirzepatide","description":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC\\[0-∞\\]) of tirzepatide.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable PK data of tirzepatide.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram*hour per milliliter (ng*h/mL)","timeFrame":"Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose","groups":[{"id":"OG000","title":"[14C]-Tirzepatide","description":"Participants received single dose of approximately 4.1 mg tirzepatide containing approximately 100 μCi of \\[14C\\]- tirzepatide administered as a subcutaneous injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"96100","spread":"13"}]}]}]},{"type":"SECONDARY","title":"PK: Maximum Concentration (Cmax) of Tirzepatide","description":"PK: Maximum Concentration (Cmax) of tirzepatide.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable PK data of tirzepatide.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/mL","timeFrame":"Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose","groups":[{"id":"OG000","title":"[14C]-Tirzepatide","description":"Participants received single dose of approximately 4.1 mg tirzepatide containing approximately 100 μCi of \\[14C\\]- tirzepatide administered as a subcutaneous injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"453","spread":"29"}]}]}]},{"type":"SECONDARY","title":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Total Radioactivity","description":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC\\[0-∞\\]) of Total Radioactivity. Total radioactivity is reported as hours\\*nanogram equivalents per milliliter (h\\*ng Eq/mL).","populationDescription":"All randomized participants who received at least one dose and had evaluable PK data for total radioactivity.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"h*ng Eq/mL","timeFrame":"Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose","groups":[{"id":"OG000","title":"[14C]-Tirzepatide","description":"Participants received single dose of approximately 4.1 mg tirzepatide containing approximately 100 μCi of \\[14C\\]- tirzepatide administered as a subcutaneous injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"}]}],"classes":[{"title":"Plasma","categories":[{"measurements":[{"groupId":"OG000","value":"87900","spread":"13"}]}]},{"title":"Whole blood","categories":[{"measurements":[{"groupId":"OG000","value":"44000","spread":"11"}]}]}]},{"type":"SECONDARY","title":"PK: Maximum Concentration (Cmax) of Total Radioactivity","description":"PK: Cmax of total radioactivity in plasma and whole blood. The Cmax of total radioactivity in plasma and whole blood are reported as nanogram equivalents per milliliter (ng Eq/mL).","populationDescription":"All randomized participants who received at least one dose and had evaluable PK data for total radioactivity.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng Eq/mL","timeFrame":"Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose","groups":[{"id":"OG000","title":"[14C]-Tirzepatide","description":"Participants received single dose of approximately 4.1 mg tirzepatide containing approximately 100 μCi of \\[14C\\]- tirzepatide administered as a subcutaneous injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"}]}],"classes":[{"title":"Plasma","categories":[{"measurements":[{"groupId":"OG000","value":"327","spread":"16"}]}]},{"title":"Whole Blood","categories":[{"measurements":[{"groupId":"OG000","value":"173","spread":"14"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Up To Day 64","description":"All randomized participants","eventGroups":[{"id":"EG000","title":"[14C]-Tirzepatide","description":"Participants received single dose of approximately 4.1 mg tirzepatide containing approximately 100 μCi of \\[14C\\]- tirzepatide administered as a subcutaneous injection.","deathsNumAffected":0,"deathsNumAtRisk":6,"seriousNumAffected":0,"seriousNumAtRisk":6,"otherNumAffected":6,"otherNumAtRisk":6}],"otherEvents":[{"term":"Palpitations","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":6}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6}]},{"term":"Toothache","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6}]},{"term":"Feeling of body temperature change","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":6}]},{"term":"Presyncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","email":"ClinicalTrials.gov@lilly.com","phone":"800-545-5979"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2020-05-19","uploadDate":"2021-05-18T00:49","filename":"Prot_000.pdf","size":913493},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2020-05-14","uploadDate":"2021-05-18T00:49","filename":"SAP_001.pdf","size":400072}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"interventionBrowseModule":{"meshes":[{"id":"D000098860","term":"Tirzepatide"}],"ancestors":[{"id":"D000067757","term":"Glucagon-Like Peptide-1 Receptor"},{"id":"D000067756","term":"Glucagon-Like Peptide Receptors"},{"id":"D043562","term":"Receptors, G-Protein-Coupled"},{"id":"D011956","term":"Receptors, Cell Surface"},{"id":"D008565","term":"Membrane Proteins"},{"id":"D011506","term":"Proteins"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D011964","term":"Receptors, Gastrointestinal Hormone"},{"id":"D018000","term":"Receptors, Peptide"}]}},"hasResults":true}