[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635954":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":63,"collaborators":24,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":24,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Incyte Corporation","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Severe Renal Impairment","EXPERIMENTAL","Participants with severe renal impairment will be enrolled in Group 1.",[13],"Drug: INCB123667",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2: End Stage Renal Disease","Participants with end stage renal disease will be enrolled in Group 2.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","INCB123667","Group 1: Single dose administered orally. Group 2: Two single doses 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],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":24},"Floridian Clinical Research","RECRUITING","Miami Lakes","Florida","33016","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-80.30866,25.90871,{"lat":52,"lon":51},{"facility":55,"status":42,"city":56,"state":44,"zip":57,"country":46,"countryCode":47,"cosmosGeoPoint":58,"geoPoint":62,"contacts":24},"Orlando Clinical Research Center","Orlando","32809",{"type":49,"coordinates":59},[60,61],-81.37924,28.53834,{"lat":61,"lon":60},{"type":64,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100635954","phase-1-a-study-to-assess-the-safety-and-pharmacokinetics-of-incb123667-when-administered-orally-to-adult-participants-with-severe-renal-impairment-or-end-stage-renal-disease-100635954",false,"NCT07559396","A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease","A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease","Inclusion Criteria:\n\n* Aged 18 to 85 years, inclusive, at the time of signing the ICF.\n* Severe renal impairment or ESRD based on CKD-EPI.\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* Participants with laboratory values outside the accepted range for participants with severe renal impairment or ESRD at screening. Participants with out-of-range values will be assessed by the investigator or designee for eligibility.\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 3 months prior to check-in.\n* Participants who required new medication or an increase in dose for renal disease 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.\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","85 Years",{"count":76,"type":77},16,"ESTIMATED","INTERVENTIONAL",[80],"PHASE1","This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with severe renal impairment or end stage renal disease.",[83],"Renal Impairment",[85,86,87],"severe renal impairment","Kidney failure","end-stage renal disease","2026-06-12",{"date":90,"type":91},"2026-06-16","ACTUAL",{"date":93,"type":91},"2026-05-29",{"date":95,"type":77},"2027-01-04",{"name":5,"class":6},2]