[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659676":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":11,"studyPopulation":11,"armGroups":28,"interventions":74,"overallOfficials":89,"centralContacts":93,"locations":102,"responsibleParty":150,"collaborators":11,"id":152,"slug":153,"hasResults":154,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":11,"eligibilityCriteria":158,"healthyVolunteers":159,"sex":160,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":11,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":11,"overallStatus":172,"whyStopped":11,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"Eli Lilly and Company","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration",null,"Baseline up to Follow up (Days 12 and 24)",{"measure":14,"description":11,"timeFrame":12},"Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) Considered by the Investigator to be Related to Study Drug Administration",[16],{"measure":17,"description":11,"timeFrame":18},"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY5625573","Baseline up to End of Treatment (Day 17)",{"allocation":20,"interventionModel":21,"interventionModelDescription":11,"primaryPurpose":22,"observationalModel":11,"timePerspective":11,"maskingInfo":23},"RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":24,"maskingDescription":11,"whoMasked":25},"DOUBLE",[26,27],"PARTICIPANT","INVESTIGATOR",[29,35,41,46,50,54,58,62,66,70],{"label":30,"type":31,"description":32,"interventionNames":33},"LY5625573 Part A - Single Dose Healthy","EXPERIMENTAL","Single dose of LY5625573 administered orally in healthy participants",[34],"Drug: LY5625573",{"label":36,"type":37,"description":38,"interventionNames":39},"Placebo Part A - Single Dose Healthy","PLACEBO_COMPARATOR","Single dose of Placebo administered orally in healthy participants",[40],"Drug: Placebo",{"label":42,"type":31,"description":43,"interventionNames":44},"LY5625573 + Midazolam Part B - Multiple Dose Healthy","Multiple-ascending dose (MAD) of LY5625573 and midazolam co-administered orally in healthy participants",[34,45],"Drug: Midazolam",{"label":47,"type":37,"description":48,"interventionNames":49},"Placebo + Midazolam Part B - Multiple Dose Healthy","Multiple doses of Placebo and midazolam co-administered orally in healthy participants",[45,40],{"label":51,"type":31,"description":52,"interventionNames":53},"LY5625573 Part C - Multiple Dose Elevated hsCRP","MAD of LY5625573 administered orally in participants with elevated high-sensitivity C-reactive protein (hsCRP)",[34],{"label":55,"type":37,"description":56,"interventionNames":57},"Placebo Part C - Multiple Dose Elevated hsCRP","Multiple doses of Placebo administered orally in participants with elevated hsCRP",[40],{"label":59,"type":31,"description":60,"interventionNames":61},"LY5625573 Part D - Healthy Japanese","MAD of LY5625573 administered orally in healthy Japanese participants",[34],{"label":63,"type":37,"description":64,"interventionNames":65},"Placebo Part D - Healthy Japanese","Multiple doses of Placebo administered orally in healthy Japanese participants",[40],{"label":67,"type":31,"description":68,"interventionNames":69},"LY5625573 Part E - Healthy Chinese","MAD of LY5625573 administered orally in healthy Chinese participants",[34],{"label":71,"type":37,"description":72,"interventionNames":73},"Placebo Part E - Healthy Chinese","Multiple doses of Placebo administered orally in healthy Chinese participants",[40],[75,82,86],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":80},"DRUG","LY5625573","Administered orally as tablet",[42,30,51,59,67],[81],"VTX3232",{"type":76,"name":83,"description":84,"armGroupLabels":85,"otherNames":11},"Midazolam","Administered orally",[42,47],{"type":76,"name":87,"description":78,"armGroupLabels":88,"otherNames":11},"Placebo",[47,36,55,63,71],[90],{"name":91,"affiliation":5,"role":92},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC\u002FGMT - 5 hours, EST)","STUDY_DIRECTOR",[94,99],{"name":95,"role":96,"phone":97,"phoneExt":11,"email":98},"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","CONTACT","1-317-615-4559","LillyTrials@Lilly.com",{"name":100,"role":96,"phone":11,"phoneExt":11,"email":101},"Physicians interested in becoming principal investigators please contact","clinical_inquiry_hub@lilly.com",[103,120,135],{"facility":104,"status":11,"city":105,"state":106,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"Collaborative Neuroscience Network - CNS","Los Alamitos","California","90720","United States","US",{"type":111,"coordinates":112},"Point",[113,114],-118.07256,33.80307,{"lat":114,"lon":113},[117],{"name":118,"role":119,"phone":11,"phoneExt":11,"email":11},"Steven Reynolds","PRINCIPAL_INVESTIGATOR",{"facility":121,"status":11,"city":122,"state":123,"zip":124,"country":108,"countryCode":109,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Fortrea Clinical Research Unit","Dallas","Texas","75247",{"type":111,"coordinates":126},[127,128],-96.80667,32.78306,{"lat":128,"lon":127},[131,133],{"name":11,"role":96,"phone":132,"phoneExt":11,"email":11},"866-429-3700",{"name":134,"role":119,"phone":11,"phoneExt":11,"email":11},"Gene Voskuhl",{"facility":136,"status":11,"city":137,"state":11,"zip":138,"country":137,"countryCode":139,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Lilly Centre for Clinical Pharmacology","Singapore","138623","SG",{"type":111,"coordinates":141},[142,143],103.85007,1.28967,{"lat":143,"lon":142},[146,148],{"name":11,"role":96,"phone":147,"phoneExt":11,"email":11},"64139811",{"name":149,"role":119,"phone":11,"phoneExt":11,"email":11},"Jeffer Hann Wei Pang",{"type":151,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659676","phase-1-a-study-of-single-and-multiple-doses-of-ly5625573-in-healthy-participants-including-japanese-and-chinese-populations-and-participants-with-inflammation-high-c-reactive-protein-100659676",false,"NCT07867340","A Study of Single and Multiple Doses of LY5625573 in Healthy Participants, Including Japanese and Chinese Populations, and Participants With Inflammation (High C-Reactive Protein)","A Phase 1, Randomized, Participant- and Investigator-Blinded, Placebo Controlled, Single-Dose and Multiple-Ascending Dose Study of Orally Administered LY5625573 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Participants, Including Japanese and Chinese Populations, and in Participants With Elevated C-Reactive Protein","Inclusion Criteria:\n\n* 21 to 65 years of age, inclusive, at the time of signing the informed consent if enrolled in Singapore\n* Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring\n* Have clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator\n* Have a hemoglobin level of at least 12.5 grams per deciliter (g\u002FdL) for participants assigned male at birth (AMAB) and at least 11.4 g\u002FdL for participants assigned female at birth (AFAB)\n* Individuals AFAB who are individual not of childbearing potential (INOCBPs) may participate in this trial\n\nParts A, B, D, and E\n\n* Have a body mass index (BMI) greater than or equal to (≥)18.5 and less than or equal to (≤) 32.0 kilograms per square meter (kg\u002Fm²)\n* Have an estimated glomerular filtration rate (eGFR), using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation 2021, of ≥90 milliliter per minute per 1.73 square meters (mL)\u002Fminute\u002F1.73 m² at screening\n\nPart C\n\n* Have a BMI ≥18.5 and \\\u003C40.0 kg\u002Fm²\n* high-sensitivity C-reactive protein (hsCRP) ≥2 milligrams per liter (mg\u002FL) and ≤15 mg\u002FL at screening and Day -2 (as confirmed by local laboratory).\n* Have an eGFR, using the CKD-EPI creatinine equation 2021, of ≥60 mL\u002Fminute\u002F1.73 m² at screening\n\nPart D\n\n* To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan\n\nPart E\n\n* To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China\n\nExclusion Criteria:\n\n* History of active tuberculosis or presence of active or latent tuberculosis\n* History or evidence of clinically significant opportunistic infection\n* History of serious local infection (for example, cellulitis or abscess) or systemic infection within 90 days prior to screening\n* Have any nonserious but active infections\n* History of more than one episode of herpes zoster infection or history of disseminated herpes zoster infection\n* Have a 12-lead electrocardiogram (ECG) abnormality\n* Clinically significant abnormal laboratory test results at screening, or positive serology test results for hepatitis B surface antigen, hepatitis B core total antibody, hepatitis C virus antibody, or human immunodeficiency virus antigen and antibody, or QuantiFERON®-TB test at screening\n\nParts A, C, D, and E\n\n* History of significant allergic reactions to any medication or known allergic reactions to drugs related to LY5625573 (VTX3232) or to any excipient in the formulation of LY5625573\n\nPart B\n\n* History of significant allergic reactions to any medication or known allergic reactions to drugs related to LY5625573 (VTX3232), midazolam, or to any excipient in the formulation of LY5625573 or midazolam\n\nParts B, C, D, and E\n\n* Have answered \"yes\" to either Question 4 or Question 5 on the \"Suicidal Ideation\" portion of the Columbia Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 90 days (at screening and\u002For Day -1 \\[Day 2 for Part B\\])\n* Have a baseline Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater, and\u002For a score of 2 or greater for either of the first 2 questions on the PHQ-9 questionnaire (at Day -1\\[Day 2 for Part B\\]",true,"ALL","18 Years","65 Years",{"count":164,"type":165},96,"ESTIMATED","INTERVENTIONAL",[168],"PHASE1","The purpose of this study is to learn if LY5625573 is safe and how well it is tolerated in healthy participants, including Japanese and Chinese participants, and in participants with high levels of a marker for inflammation (C-reactive protein). The study will also look at how the body absorbs, breaks down, and clears the study drug (pharmacokinetics), how the study drug works in the body, and whether it interacts with certain other medications by affecting how the body processes them.\n\nParticipation in the study will last up to approximately 7 weeks for Part A and 8.5 weeks for Parts B, C, D, and E. For each participant there will be one stay at the clinical research unit (CRU) lasting 5 nights for Part A, 18 nights for Parts B and C, and 17 nights for Parts D and E.",[171],"C-Reactive Protein","NOT_YET_RECRUITING","2026-10-05",{"date":175,"type":176},"2026-10-09","ACTUAL",{"date":178,"type":165},"2026-09",{"date":180,"type":165},"2027-01",{"name":5,"class":6},3]