{"protocolSection":{"identificationModule":{"nctId":"NCT05469126","orgStudyIdInfo":{"id":"18507"},"secondaryIdInfos":[{"id":"J2A-MC-GZGM","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants","officialTitle":"A Phase 1, Open-label, Drug Interaction Study to Investigate the Effect of Multiple Doses of Clarithromycin on the Pharmacokinetics of LY3502970 in Healthy Participants"},"statusModule":{"statusVerifiedDate":"2026-04-15","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-08-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-11-03","type":"ACTUAL"},"completionDateStruct":{"date":"2022-11-03","type":"ACTUAL"},"studyFirstSubmitDate":"2022-07-20","studyFirstSubmitQcDate":"2022-07-20","studyFirstPostDateStruct":{"date":"2022-07-21","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-04-30","resultsFirstSubmitQcDate":"2026-04-30","resultsFirstPostDateStruct":{"date":"2026-05-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-04-30","lastUpdatePostDateStruct":{"date":"2026-05-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with clarithromycin in healthy participants. This study will last up to approximately 85 days for each participant."},"conditionsModule":{"conditions":["Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":26,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"LY3502970 alone (Period 1)","type":"EXPERIMENTAL","description":"Participants received a single 3 milligram (mg) dose of LY3502970 administered orally on Day 1. Participants were fasted overnight and remained in a fasted state for 4 hours after taking the study drug.","interventionNames":["Drug: LY3502970"]},{"label":"Clarithromycin + LY3502970 (Period 2)","type":"EXPERIMENTAL","description":"Participants received below:\n\nDay 15 to 31: 500 mg of clarithromycin administered orally every 12 hours (Q12H).\n\nDay 21: 500 mg clarithromycin followed by 3 mg LY3502970 administered orally.\n\nParticipants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later","interventionNames":["Drug: LY3502970","Drug: Clarithromycin"]}],"interventions":[{"type":"DRUG","name":"LY3502970","description":"Administered orally.","armGroupLabels":["Clarithromycin + LY3502970 (Period 2)","LY3502970 alone (Period 1)"]},{"type":"DRUG","name":"Clarithromycin","description":"Administered orally.","armGroupLabels":["Clarithromycin + LY3502970 (Period 2)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity AUC(0-∞) of LY3502970","description":"PK: AUC(0-∞) of LY3502970 is reported.","timeFrame":"Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose"},{"measure":"PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of LY3502970","description":"PK: AUC(0-tlast) of LY3502970 is reported.","timeFrame":"Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose"},{"measure":"PK: Maximum Observed Concentration (Cmax) of LY3502970","description":"PK: Cmax of LY3502970 is reported.","timeFrame":"Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Participants who are overtly healthy as determined by medical evaluation\n* Participants with a body weight of 45 kilograms (kg) or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²)\n* Participants who have a hemoglobin level of at least 11.4 grams/deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants\n* Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential\n\nExclusion Criteria:\n\n* Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs\n* Participants who regularly use known drugs of abuse\n* Women who are lactating and who are of child-bearing potential\n* Participants who have known allergies to LY3502970, related compounds, or any components of the formulation","healthyVolunteers":true,"sex":"ALL","minimumAge":"21 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":"Lilly Centre for Clinical Pharmacology","city":"Singapore","zip":"138623","country":"Singapore","geoPoint":{"lat":1.28967,"lon":103.85007}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"3 mg LY3502970 (Day 1) and 500 mg Clarithromycin Q12H + 3 mg LY3502970 (Day 21)","description":"Participants received below\n\nPeriod 1:\n\nDay 1: Single dose of 3 milligram (mg) LY3502970 administered orally on Day 1.\n\nParticipants were fasted overnight and remained in a fasted state with no access to food for 4 hours after taking the study drug.\n\nPeriod 2:\n\nDay 15 to 31: 500 mg of clarithromycin administered orally every 12 hours (Q12H).\n\nDay 21: 500 mg clarithromycin followed by 3 mg LY3502970 administered orally.\n\nParticipants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later\n\nThere was a washout period of at least 14 days between Period 1 and Period 2."}],"periods":[{"title":"LY3502970 Alone (Period 1)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"26"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"26"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"21"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"}]}]},{"title":"Clarithromycin + LY3502970 (Period 2)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"21"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"21"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"21"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All participants who received at least one dose of the study drug.","groups":[{"id":"BG000","title":"Overall Participants","description":"Participants received below\n\nPeriod 1:\n\nDay 1: Single dose of 3 mg LY3502970 administered orally on Day 1. Participants were fasted overnight and remained in a fasted state with no access to food for 4 hours after taking the study drug.\n\nPeriod 2:\n\nDay 15 to 31: 500 mg of clarithromycin administered orally Q12H.\n\nDay 21: 500 mg clarithromycin followed by 3 mg LY3502970 administered orally.\n\nParticipants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later\n\nThere was a washout period of at least 14 days between Period 1 and Period 2."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"26"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.9","spread":"11.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"3"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"23"}]}]}]},{"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":"26"}]},{"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":"26"}]},{"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":"0"}]},{"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":"Singapore","categories":[{"measurements":[{"groupId":"BG000","value":"26"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity AUC(0-∞) of LY3502970","description":"PK: AUC(0-∞) of LY3502970 is reported.","populationDescription":"All participants who received at least one dose of LY3502970 and had evaluable PK data. Participants may have been excluded from the PK summary statistics and statistical analysis if a participant had an adverse event (AE) of vomiting that occurred at or before 2 times median time of maximum observed drug concentration (tmax).","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram*hour per milliliter (ng*hr/mL)","timeFrame":"Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose","groups":[{"id":"OG000","title":"LY3502970 (Day 1)","description":"Period 1: Participants received a single 3 mg dose of LY3502970 administered orally on Day 1. 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On day 21, one hour after the 500 mg of clarithromycin was administered, a single dose of 3 mg of LY3502970 was administered orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"380","spread":"40"},{"groupId":"OG001","value":"1380","spread":"31"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Geometric LS Mean Ratio","paramValue":"3.54","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.96","ciUpperLimit":"4.22","estimateComment":"The least square means (LSMs) and differences in LSMs were back transformed to produce the geometric least square means (GLSMs) and ratio between GLSMs."}]},{"type":"PRIMARY","title":"PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of LY3502970","description":"PK: AUC(0-tlast) of LY3502970 is reported.","populationDescription":"All participants who received at least one dose of LY3502970 and had evaluable PK data. 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On day 21, one hour after the 500 mg of clarithromycin was administered, a single dose of 3 mg of LY3502970 was administered orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"333","spread":"37"},{"groupId":"OG001","value":"1270","spread":"30"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Geometric LS Mean Ratio","paramValue":"3.69","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.19","ciUpperLimit":"4.28","estimateComment":"The least square means (LSMs) and differences in LSMs were back transformed to produce the geometric least square means (GLSMs) and ratio between GLSMs."}]},{"type":"PRIMARY","title":"PK: Maximum Observed Concentration (Cmax) of LY3502970","description":"PK: Cmax of LY3502970 is reported.","populationDescription":"All participants who received at least one dose of LY3502970 and had evaluable PK data. Participants may have been excluded from the PK summary statistics and statistical analysis if a participant had an AE of vomiting that occurred at or before 2 times median time of tmax.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanograms per milliliter (ng/mL)","timeFrame":"Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose","groups":[{"id":"OG000","title":"LY3502970 (Day 1)","description":"Period 1: Participants received a single 3 mg dose of LY3502970 administered orally on Day 1. 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25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":26},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":21},{"groupId":"EG002","numEvents":5,"numAffected":4,"numAtRisk":21}]},{"term":"Catheter site swelling","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":26},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":21},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":21}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":26},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":21},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":21}]},{"term":"Vessel puncture site bruise","organSystem":"General 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