[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650770":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":29,"locations":23,"responsibleParty":34,"collaborators":23,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":23,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":23,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":61,"whyStopped":23,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":23},{"fullName":5,"class":6},"Arcus Biosciences, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Moderate Hepatic Impairment","EXPERIMENTAL","Administered as specified in the treatment arm.",[13],"Drug: Casdatifan",{"label":15,"type":10,"description":11,"interventionNames":16},"Group 2: Healthy Control Participants",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Casdatifan","Participants will receive a 100 mg single oral dose of casdatifan.",[9,15],null,[25],{"name":26,"affiliation":27,"role":28},"Medical Director","Arcus Biosciences","STUDY_DIRECTOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":23,"email":33},"CONTACT","+1-510-462-3330","ClinicalTrialInquiry@arcusbio.com",{"type":35,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100650770","phase-1-comparative-pk-assessment-study-of-casdatifan-in-moderate-hepatically-impaired-participants-versus-matched-participants-with-normal-hepatic-function-100650770",false,"NCT07751250","Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function","A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetics of Casdatifan (AB521) in Participants With Moderate Hepatic Impairment Compared to Healthy Matched Participants","Inclusion Criteria:\n\nAll Participants:\n\n* Male participants must be vasectomized\n* BMI ≥ 18.0 and ≤ 42.0 kg\u002Fm2 and body weight ≥ 45 kg at screening.\n\nParticipants with Moderate HI (Group 1)\n\n* Is classified as having moderate HI by the Child-Pugh classification system (Class B, score of 7 to 9, inclusive) at screening.\n* Has a diagnosis of chronic (\\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency at screening\n\nHealthy Participants:\n\n* Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee\n\nExclusion Criteria:\n\nAll Participants:\n\n* Participants with Gilbert's syndrome.\n\nParticipants with Moderate HI (Group 1):\n\n* Positive for HBsAg or HCV Ab, and detectable viral load at screening.\n* Severe complications of liver disease within the preceding 3 months of screening.\n* Fluctuating or rapidly deteriorating hepatic function from screening until prior to dosing, in the opinion of the PI or designee.\n\nHealthy Control Participants:\n\n* History or presence of clinically significant medical or psychiatric condition or disease, or presence of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",true,"ALL","18 Years","84 Years",{"count":48,"type":49},16,"ESTIMATED","INTERVENTIONAL",[52],"PHASE1","The purpose of the study is to compare the single dose PK of casdatifan between participants with moderate hepatic impairment (HI) and healthy matched control participants with normal hepatic function.",[55,56],"Healthy Participants","Hepatic Impairment",[20,58,59,60,56],"AB521","HIF-2α","Pharmacokinetics","NOT_YET_RECRUITING","2026-08-03",{"date":64,"type":65},"2026-08-07","ACTUAL",{"date":67,"type":49},"2026-08",{"date":69,"type":49},"2027-05",{"name":5,"class":6}]