{"protocolSection":{"identificationModule":{"nctId":"NCT05810597","orgStudyIdInfo":{"id":"18698"},"secondaryIdInfos":[{"id":"I8F-MC-GPIP","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices","officialTitle":"A Bioequivalence Study to Compare the Pharmacokinetics of Tirzepatide Administered Subcutaneously by a Test Device (Test Formulation) Versus Reference Device (Reference Formulation) in Healthy Participants"},"statusModule":{"statusVerifiedDate":"2024-07-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-04-03","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-07-17","type":"ACTUAL"},"completionDateStruct":{"date":"2023-07-17","type":"ACTUAL"},"studyFirstSubmitDate":"2023-03-31","studyFirstSubmitQcDate":"2023-03-31","studyFirstPostDateStruct":{"date":"2023-04-12","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-07-17","resultsFirstSubmitQcDate":"2024-07-17","resultsFirstPostDateStruct":{"date":"2024-10-15","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-07-17","lastUpdatePostDateStruct":{"date":"2024-10-15","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":true},"descriptionModule":{"briefSummary":"The main purpose of this study is to look at the amount of the study drug, tirzepatide, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of tirzepatide and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 14 weeks, including screening."},"conditionsModule":{"conditions":["Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":65,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP)","type":"EXPERIMENTAL","description":"Participants received a single dose of 5 milligrams (mg) tirzepatide administered subcutaneously (SC) via an SDP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 2.\n\nThere was a washout period of at least 35 days between tirzepatide dose administrations.","interventionNames":["Drug: Tirzepatide","Device: Single Dose Pen","Device: Multi-use Prefilled 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equivalent of 10 cigarettes per day\n* Is a known user of drugs of abuse","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_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":"Qps-Mra, Llc","city":"South Miami","state":"Florida","zip":"33143","country":"United States","geoPoint":{"lat":25.7076,"lon":-80.29338}},{"facility":"ICON Early Phase Services","city":"San Antonio","state":"Texas","zip":"78209","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"ICON","city":"Salt Lake City","state":"Utah","zip":"84124","country":"United 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tirzepatide administered SC via an SDP in Period 2.\n\nThere was a washout period of at least 35 days between tirzepatide dose administrations."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"65"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"41.10","spread":"13.32"},{"groupId":"BG001","value":"41.10","spread":"14.52"},{"groupId":"BG002","value":"41.10","spread":"13.79"}]}]}]},{"title":"Sex: Female, 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