[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609820":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":77,"collaborators":30,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":30,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":30,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":30,"overallStatus":35,"whyStopped":30,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Calderasib","EXPERIMENTAL","All participants will receive a single oral dose of calderasib on Day 1.",[13],"Drug: Calderasib",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Oral Tablet",[9],[20],"MK-1084",[22],{"name":23,"affiliation":5,"role":24},"Medical Director","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Toll Free Number","CONTACT","1-888-577-8839",null,"Trialsites@msd.com",[33,51,64],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Arizona Clinical Trials ( Site 0003)","RECRUITING","Chandler","Arizona","85225","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-111.84125,33.30616,{"lat":45,"lon":44},[48],{"name":49,"role":28,"phone":50,"phoneExt":30,"email":30},"Study Coordinator","210-253-3426",{"facility":52,"status":35,"city":53,"state":54,"zip":55,"country":39,"countryCode":40,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Orlando Clinical Research Center ( Site 0001)","Orlando","Florida","32809",{"type":42,"coordinates":57},[58,59],-81.37924,28.53834,{"lat":59,"lon":58},[62],{"name":49,"role":28,"phone":63,"phoneExt":30,"email":30},"407-240-7878",{"facility":65,"status":35,"city":66,"state":67,"zip":68,"country":39,"countryCode":40,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"The Texas Liver Institute ( Site 0002)","San Antonio","Texas","78215",{"type":42,"coordinates":70},[71,72],-98.49363,29.42412,{"lat":72,"lon":71},[75],{"name":49,"role":28,"phone":76,"phoneExt":30,"email":30},"480-470-4000",{"type":78,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100609820","phase-1-a-study-of-calderasib-mk-1084-in-participants-with-hepatic-impairment-and-healthy-volunteers-mk-1084-017-100609820",false,"NCT07219550","A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)","A Clinical Study to Evaluate the Effect of Hepatic Impairment on the Single-Dose Pharmacokinetics of MK-1084","The main inclusion criteria include but are not limited to:\n\nAll participants:\n\n* Has a body mass index (BMI) between 18.0 and 42.0 kg\u002Fm\\^2\n\nParticipants with hepatic impairment (HI):\n\n* Has a diagnosis of chronic, stable hepatic insufficiency at screening with features of cirrhosis\n\nHealthy volunteers:\n\n* Is medically healthy with no clinically significant medical history\n\nThe main exclusion criteria include but are not limited to:\n\nAll participants:\n\n* Has a history of gastrointestinal disease which may affect food and drug absorption\n* Has a history of cancer (malignancy)\n* Has a positive result for human immunodeficiency virus (HIV)\n* Has had major surgery and\u002For donated or lost significant volume of blood within 56 days prior to dosing\n\nParticipants with HI:\n\n* Has had severe complications of liver disease within the preceding 3 months of screening\n* Has a history of recent (within 3 months prior to screening) variceal bleeds\n* Has evidence of hepatorenal syndrome\n* Is not in sufficient health, with regard to stability of HI, to undergo participation in the study with anticipated survival of \\\u003C 3 months\n* Has a history of liver or other solid organ transplantation\n* Has an active infection requiring systemic therapy\n* Requires paracentesis more often than 2 times per month\n* Has transjugular intrahepatic portosystemic shunt and\u002For has undergone portacaval shunting\n* Has received antiviral and\u002For immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to dosing\n* Is using HIV protease inhibitors\n* Is positive for Hepatitis B surface antigen (HBsAg)\n* Is positive for HCV\n\nHealthy volunteers:\n\n* Has positive results for HBsAg or HCV",true,"ALL","18 Years","80 Years",{"count":91,"type":92},58,"ESTIMATED","INTERVENTIONAL",[95],"PHASE1","The purpose of this study is to learn what happens to calderasib levels in a person's body over time. Researchers will measure what happens to calderasib levels in the body when it is given to participants with hepatic (liver) impairment and healthy participants. Researchers also want to learn about the safety of MK-1084 when it is given to people with hepatic impairment and if people with hepatic impairment can tolerate it.",[98,99],"Healthy","Hepatic Impairment","2026-03-03",{"date":102,"type":103},"2026-03-05","ACTUAL",{"date":105,"type":103},"2025-11-05",{"date":107,"type":92},"2026-08-14",{"name":5,"class":6},3]