[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635960":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":80,"collaborators":24,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":24,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":24,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Incyte Corporation","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Moderate hepatic function","EXPERIMENTAL","Participants with moderate hepatic impairment will be enrolled in Cohort 1.",[13],"Drug: INCB123667",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: Severe hepatic function","Participants with severe hepatic impairment will be enrolled in Cohort 2.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","INCB123667","single dose administered orally",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Incyte Medical Monitor","STUDY_DIRECTOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Incyte Corporation Call Center (US)","CONTACT","1.855.463.3463","medinfo@incyte.com",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Incyte Corporation Call Center (ex-US)","+800 00027423","eumedinfo@incyte.com",[40,54,64,74],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":24},"Arizona Clinical Trials - the Institute For Liver Health","RECRUITING","Chandler","Arizona","85225","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-111.84125,33.30616,{"lat":52,"lon":51},{"facility":55,"status":42,"city":56,"state":57,"zip":58,"country":46,"countryCode":47,"cosmosGeoPoint":59,"geoPoint":63,"contacts":24},"Orlando Clinical Research Center","Orlando","Florida","32809",{"type":49,"coordinates":60},[61,62],-81.37924,28.53834,{"lat":62,"lon":61},{"facility":65,"status":42,"city":66,"state":67,"zip":68,"country":46,"countryCode":47,"cosmosGeoPoint":69,"geoPoint":73,"contacts":24},"Texas Liver Institute - American Research Corporation","San Antonio","Texas","78215",{"type":49,"coordinates":70},[71,72],-98.49363,29.42412,{"lat":72,"lon":71},{"facility":75,"status":42,"city":66,"state":67,"zip":76,"country":46,"countryCode":47,"cosmosGeoPoint":77,"geoPoint":79,"contacts":24},"Pinnacle Clinical Research","78229",{"type":49,"coordinates":78},[71,72],{"lat":72,"lon":71},{"type":81,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100635960","phase-1-a-study-to-assess-the-safety-and-pharmacokinetics-of-incb123667-when-administered-orally-to-adult-participants-with-moderate-or-severe-hepatic-impairment-100635960",false,"NCT07559474","A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment","A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment","Inclusion Criteria:\n\n* Ability to comprehend and willingness to sign a written ICF for the study.\n* Aged 18 to 80 years, inclusive, at the time of signing the ICF.\n* Moderate or severe hepatic impairment based on CP score.\n* Medical findings consistent with the degree of hepatic dysfunction, determined by medical history, physical examination, vital sign measurements, 12-lead ECGs, and clinical laboratory determinations at screening or check-in (as applicable). Participants with abnormal findings considered not clinically significant by the medical monitor or investigator are eligible.\n* Body mass index of 18.0 to 43.0 kg\u002Fm2 (inclusive).\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* Participants who have a current, functioning organ transplant or are on the national transplant list and expected to receive a transplant within 3 months.\n* Tobacco or nicotine-containing product use of \\> 10 cigarettes per day within 1 month before screening.\n* Participants who had a change in disease status within 30 days before screening, as documented by the participant's medical history, that is deemed clinically significant by the investigator.\n* Participants who have a history of paracentesis within 2 months prior to check-in.\n* Participants who required new medication or an increase in dose for hepatic encephalopathy within 3 months prior to check-in.\n* Participants who have a history of unstable diabetes mellitus (as evidenced by hemoglobin A1c ≥ 10.0%). Medications for treatment of diabetes mellitus must be reviewed and approved by the investigator and medical monitor. Participants who have a portal systemic shunt. Up to 3 participants with transjugular intrahepatic portosystemic shunt may be included.\n* Participants who had esophageal banding within 3 months prior to check-in or required any other treatment for gastrointestinal bleeding within 6 months prior to check-in.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","ALL","18 Years","80 Years",{"count":93,"type":94},16,"ESTIMATED","INTERVENTIONAL",[97],"PHASE1","This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with moderate or severe hepatic impairment.",[100,101],"Hepatic Insufficiency","Liver Diseases",[103,104],"hepatic impairment","liver impairment (moderate and severe)","2026-06-12",{"date":107,"type":108},"2026-06-16","ACTUAL",{"date":110,"type":108},"2026-05-27",{"date":112,"type":94},"2027-04-13",{"name":5,"class":6},4]