[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07219550":3,"trial-entities:NCT07219550":139,"trial-summary:NCT07219550":143},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":64,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":75,"eligibility_criteria":76,"std_ages":100,"locations":103,"central_contacts":129,"overall_officials":130,"references":134,"see_also_links":135},"NCT07219550","1084-017","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","COMPLETED","2026-07-15","2026-08","2026-08-04","2025-11-05","Merck Sharp & Dohme LLC","INDUSTRY",false,"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.",null,[19,20],"Healthy","Hepatic Impairment",[],"INTERVENTIONAL","BASIC_SCIENCE",[25],"PHASE1",{"count":27,"type":28},32,"ACTUAL",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Calderasib","Oral Tablet",[32],[36],"MK-1084",[38,42,45,49,52,55,58,61],{"measure":39,"description":40,"timeFrame":41},"Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib","Blood samples will be collected to determine the AUC0-last of calderasib in plasma.","At designated timepoints up to approximately 7 days post-dose",{"measure":43,"description":44,"timeFrame":41},"Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Calderasib","Blood samples will be collected to determine the AUC0-inf of calderasib in plasma.",{"measure":46,"description":47,"timeFrame":48},"Area Under the Concentration Versus Time Curve from 0 to 24 hours post-dose (AUC0-24) of Calderasib","Blood samples will be collected to determine the AUC0-24 of calderasib in plasma.","Up to approximately 24 hours post-dose",{"measure":50,"description":51,"timeFrame":41},"Maximum Observed Drug Concentration (Cmax) of Calderasib","Blood samples will be collected to determine the Cmax of calderasib in plasma.",{"measure":53,"description":54,"timeFrame":41},"Time to Maximum Observed Drug Concentration (Tmax) of Calderasib","Blood samples will be collected to determine the Tmax of calderasib in plasma.",{"measure":56,"description":57,"timeFrame":41},"Apparent Terminal Half-life (t1\u002F2) of Calderasib","Blood samples will be collected to determine the t1\u002F2 of calderasib in plasma.",{"measure":59,"description":60,"timeFrame":41},"Apparent Clearance (CL\u002FF) of Calderasib","Blood samples will be collected to determine the CL\u002FF of calderasib in plasma.",{"measure":62,"description":63,"timeFrame":41},"Apparent Volume of Distribution During Terminal Phase (Vz\u002FF) of Calderasib","Blood samples will be collected to determine the Vz\u002FF of calderasib in plasma.",[65,69],{"measure":66,"description":67,"timeFrame":68},"Number of Participants Who Experience an Adverse Event (AE)","An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants experiencing AEs will be reported.","Up to approximately 14 days",{"measure":70,"description":71,"timeFrame":68},"Number of Participants Who Discontinue Study Due to an AE","An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants discontinuing the study due to AEs will be reported.","ALL","18 Years","80 Years",true,{"inclusion":77,"exclusion":81,"raw_text":99},[78,79,80],"Has a body mass index (BMI) between 18.0 and 42.0 kg\u002Fm\\^2","Has a diagnosis of chronic, stable hepatic insufficiency at screening with features of cirrhosis","Is medically healthy with no clinically significant medical history",[82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98],"Has a history of gastrointestinal disease which may affect food and drug absorption","Has a history of cancer (malignancy)","Has a positive result for human immunodeficiency virus (HIV)","Has had major surgery and\u002For donated or lost significant volume of blood within 56 days prior to dosing","Has had severe complications of liver disease within the preceding 3 months of screening","Has a history of recent (within 3 months prior to screening) variceal bleeds","Has evidence of hepatorenal syndrome","Is not in sufficient health, with regard to stability of HI, to undergo participation in the study with anticipated survival of \\\u003C 3 months","Has a history of liver or other solid organ transplantation","Has an active infection requiring systemic therapy","Requires paracentesis more often than 2 times per month","Has transjugular intrahepatic portosystemic shunt and\u002For has undergone portacaval shunting","Has received antiviral and\u002For immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to dosing","Is using HIV protease inhibitors","Is positive for Hepatitis B surface antigen (HBsAg)","Is positive for HCV","Has positive results for HBsAg or HCV","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",[101,102],"ADULT","OLDER_ADULT",[104,113,121],{"facility":105,"city":106,"state":107,"zip":108,"country":109,"geoPoint":110},"Arizona Clinical Trials ( Site 0003)","Chandler","Arizona","85225","United States",{"lat":111,"lon":112},33.30616,-111.84125,{"facility":114,"city":115,"state":116,"zip":117,"country":109,"geoPoint":118},"Orlando Clinical Research Center ( Site 0001)","Orlando","Florida","32809",{"lat":119,"lon":120},28.53834,-81.37924,{"facility":122,"city":123,"state":124,"zip":125,"country":109,"geoPoint":126},"The Texas Liver Institute ( Site 0002)","San Antonio","Texas","78215",{"lat":127,"lon":128},29.42412,-98.49363,[],[131],{"name":132,"affiliation":13,"role":133},"Medical Director","STUDY_DIRECTOR",[],[136],{"label":137,"url":138},"Merck Clinical Trials Information","https:\u002F\u002Fwww.merckclinicaltrials.com\u002F",{"nct_id":4,"conditions":140,"biomarkers":142},[19,141],"Liver Failure",[],{"nct_id":4,"found":75,"summary":144,"prompt_version":154},{"design":145,"status":146,"heading":147,"summary":148,"follow_up":149,"word_count":150,"commitments":151,"compensation":152,"drugs_mentioned":153},"This is an interventional study involving 58 participants, including both healthy volunteers and individuals with hepatic impairment.","completed","A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers","This study is looking at a drug called Calderasib (MK-1084) to understand how it moves through the body in people with liver problems (hepatic impairment) and in healthy individuals. Researchers want to see how much Calderasib is in the body over time and how safe and tolerable it is for people with liver impairment. You might be able to join if you are between 18 and 80 years old and have a BMI between 18.0 and 42.0. Participants with liver impairment must have a chronic, stable diagnosis of liver insufficiency with cirrhosis. Healthy volunteers must be medically healthy. The study aims to enroll 58 participants.","Researchers will measure drug levels for up to approximately 7 days after you take the dose.",105,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]