[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590047":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":41,"responsibleParty":66,"collaborators":36,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":36,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":36,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":44,"whyStopped":36,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Exelixis","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Moderate HI","EXPERIMENTAL","Participants with moderate HI will receive a single oral dose of zanzalintinib tablet on Day 1.",[13],"Drug: Zanzalintinib",{"label":15,"type":16,"description":17,"interventionNames":18},"Matched Healthy Control","ACTIVE_COMPARATOR","Matched healthy control participants will receive a single oral dose of zanzalintinib tablet on Day 1.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Zanzalintinib","Administered as specified in the treatment arm.",[15,9],[26],"XL092",[28],{"name":29,"affiliation":5,"role":30},"Medical Director","STUDY_DIRECTOR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Exelixis Clinical Trials","CONTACT","1-888-EXELIXIS (888-393-5494)",null,"druginfo@exelixis.com",{"name":39,"role":34,"phone":40,"phoneExt":36,"email":36},"Backup or International","650-837-7400",[42,56],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":36},"Exelixis Clinical Site #1","RECRUITING","Orlando","Florida","32809","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-81.37924,28.53834,{"lat":54,"lon":53},{"facility":57,"status":44,"city":58,"state":59,"zip":60,"country":48,"countryCode":49,"cosmosGeoPoint":61,"geoPoint":65,"contacts":36},"Exelixis Clinical Site #2","San Antonio","Texas","78215",{"type":51,"coordinates":62},[63,64],-98.49363,29.42412,{"lat":64,"lon":63},{"type":67,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100590047","phase-1-pharmacokinetics-pk-and-safety-of-zanzalintinib-in-participants-with-moderate-hepatic-impairment-hi-100590047",false,"NCT06962332","Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)","A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment","Key Inclusion Criteria:\n\n* All Participants:\n\n  * No clinically significant medical history (aside from the HI for participants in the HI group only), physical examination findings, or vital signs, as deemed by the investigator.\n  * A continuous non-smoker or moderate smoker who smokes ≤ 10 cigarettes, ≤ 2 cigars, or ≤2 pipes per day and agree to limit smoking during the confinement period to ≤ 4 cigarettes or ≤1 cigar or pipe per day. Participant must agree to maintain the same smoking status (smoker or non-smoker) from screening and until after the last PK sample collection.\n  * Has not donated blood within 30 days of dosing or plasma within 7 days of dosing and must agree to refrain from blood donation until at least 30 days following dosing.\n* Participants with Moderate HI Only:\n\n  * Adequate bone marrow function, at the screening and dosing visit.\n  * Is classified as having moderate HI by the Child-Pugh classification system (Class B, score of 7 to 9, inclusive) and has a total bilirubin value within the range of \\> 1.5\\* upper limit of normal (ULN) and ≤ 3\\* ULN at the screening and dosing visit.\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 the screening visit with features of cirrhosis due to any etiology.\n* Healthy Control Participants Only:\n\n  * Age must be within ± 10 years of the mean age of participants with moderate HI. The sex ratio (male\u002Ffemale ratio), and smoking status ratio (smokers\u002Fnon-smokers ratio) must be the same to the sex and smoking status ratio of participants with moderate HI.\n\nKey Exclusion Criteria:\n\n* All Participants:\n\n  * • History of any medical or surgical conditions that would potentially alter absorption, distribution, metabolism, and\u002For excretion of orally administered drugs.\n  * Has or is at risk for major cardiac events or dysfunction.\n* Participants with Moderate HI Only:\n\n  * History of liver or other solid organ transplant.\n  * Fluctuating or rapidly deteriorating hepatic function (the definition of the change of more than 1 Child-Pugh point) within 30 days prior to Day 1, in the opinion of the investigator and Sponsor.\n  * Symptoms or history of Grade 3 or worse degree of encephalopathy within 3 months of dosing.\n  * Clinical evidence of severe ascites at the screening visit or at check in.\n* Healthy Control Participants Only:\n\n  * History or presence of alcohol or drug abuse within the past 2 years prior to dosing.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",true,"ALL","18 Years","75 Years",{"count":80,"type":81},20,"ESTIMATED","INTERVENTIONAL",[84],"PHASE1","The primary purpose of this study is to evaluate the plasma PK of zanzalintinib following a single dose in participants with moderate liver dysfunction compared to matched healthy participants with normal liver function.",[87,88],"Hepatic Impairment","Moderate Hepatic Impairment",[22,90],"Pharmacokinetics","2025-06-17",{"date":93,"type":94},"2025-06-22","ACTUAL",{"date":96,"type":94},"2025-05-13",{"date":98,"type":81},"2026-04",{"name":5,"class":6},2]