[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658545":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":42,"studyPopulation":42,"armGroups":49,"interventions":60,"overallOfficials":66,"centralContacts":70,"locations":42,"responsibleParty":80,"collaborators":42,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":42,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":42,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":105,"whyStopped":42,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":42},{"fullName":5,"class":6},"Incyte Corporation","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":42},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"PK for plasma INCB161734: Cmax","Defined as the maximum plasma concentration.","Up to approximately 1.5 months",{"measure":14,"description":15,"timeFrame":12},"PK for plasma INCB161734: AUClast","Defined as the area under the concentration-time curve from time zero to time of the last quantifiable concentration.",{"measure":17,"description":18,"timeFrame":12},"PK for plasma INCB161734: AUCinf","Defined as the area under concentration-time curve from time zero extrapolated to infinity.",[20,24,27,30,33,36,39],{"measure":21,"description":22,"timeFrame":23},"Number of Treatment-Emergent Adverse Events (TEAEs)","Adverse events reported for the first time or worsening of a pre-existing event, occurring after first dose of study drug.","Up to approximately 1.5 months and 15 days",{"measure":25,"description":26,"timeFrame":12},"PK for plasma INCB161734: Tmax","Defined as the time to maximum concentration.",{"measure":28,"description":29,"timeFrame":12},"PK for plasma INCB161734: t½","Defined as the terminal-phase half-life.",{"measure":31,"description":32,"timeFrame":12},"PK for plasma INCB161734: Tlast","Defined as the time at which the last quantifiable concentration is observed.",{"measure":34,"description":35,"timeFrame":12},"PK for plasma INCB161734: CL\u002FF","Defined as the apparent clearance.",{"measure":37,"description":38,"timeFrame":12},"PK for plasma INCB161734: Vz\u002FF","Defined as the apparent volume of distribution.",{"measure":40,"description":41,"timeFrame":12},"PK for plasma INCB161734: AUCextrap%","Defined as the percentage of area under the plasma concentration-time curve from time zero extrapolated to infinity obtained by forward extrapolation.",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":48,"maskingDescription":42,"whoMasked":42},"NONE",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"Cohort 1: Moderate hepatic impairment","EXPERIMENTAL","Participants with moderate hepatic impairment will be enrolled in Cohort 1.",[55],"Drug: INCB161734",{"label":57,"type":52,"description":58,"interventionNames":59},"Cohort 2: Severe hepatic impairment","Participants with severe hepatic impairment will be enrolled in Cohort 2.",[55],[61],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":42},"DRUG","INCB161734","single dose administered orally",[51,57],[67],{"name":68,"affiliation":5,"role":69},"Incyte Medical Monitor","STUDY_DIRECTOR",[71,76],{"name":72,"role":73,"phone":74,"phoneExt":42,"email":75},"Incyte Corporation Call Center (US)","CONTACT","1.855.463.3463","medinfo@incyte.com",{"name":77,"role":73,"phone":78,"phoneExt":42,"email":79},"Incyte Corporation Call Center (ex-US)","+800 00027423","eumedinfo@incyte.com",{"type":81,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100658545","phase-1-a-study-to-evaluate-the-pharmacokinetics-and-safety-of-incb161734-in-participants-with-hepatic-impairment-100658545",false,"NCT07853040","A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Hepatic Impairment","A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Hepatic Impairment","Inclusion Criteria:\n\n* Ability to comprehend and willingness to sign a written ICF for the study.\n* Age 18 to 80 years (inclusive) at the time of signing the ICF.\n* Moderate or severe hepatic impairment based on Child-Pugh 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 examinations at screening and check-in.\n* BMI of 18.0 to 44.0 kg\u002Fm2 (inclusive) at screening.\n* Ability to swallow and retain oral tablets.\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* In the opinion of the investigator, history of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and\u002For neurological disease within 6 months before screening or evidence of rapidly deteriorating hepatic function.\n* History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study.\n* Current, functioning organ transplant or on the national transplant list and expected to receive a transplant within 3 months.\n* History of an autoimmune disease diagnosis (eg, myasthenia gravis).\n* History of malignancy within 5 years before screening, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.\n* History of clinically significant GI disease or surgery (cholecystectomy and appendectomy are allowed) that could impact the absorption of study drug.\n* Severe ascites (ascites requiring paracentesis more than twice every 4 weeks) or encephalopathy ≥ Grade 2 (precludes them from understanding and signing an ICF).\n* Any major surgery within 4 weeks before screening.\n* Donation of blood within 4 weeks before screening (within 2 weeks for plasma only).\n* Blood transfusion within 4 weeks before check-in (Day -1).\n* Current or recent history (within 30 days before screening) of a clinically significant bacterial, fungal, parasitic, or mycobacterial infection, or currently receiving systemic antibiotics or current clinically significant viral infection at screening or check-in (Day -1).\n* History of alcoholism within 3 months before screening.\n* Positive breath, urine, or blood test for ethanol or positive serum or urine screen for drugs of abuse that is not otherwise explained by permitted concomitant medications.\n* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before study drug administration with another investigational medication or current enrollment in another investigational drug study.\n* Current treatment or treatment within 15 days or 5 half-lives (whichever is longer) before study drug administration with an inducer or inhibitor of CYP3A4, P-gp, or BCRP.\n* Use of prescription drugs (including hormonal contraceptives) within 14 days before study drug administration or nonprescription medications\u002Fproducts (including megadose vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations as well as pre\u002Fprobiotics) within 7 days before study drug administration.\n\n  * Note 1: Occasional acetaminophen, standard-dose ibuprofen, and standard-dose vitamins are permitted.\n  * Note 2: Established therapy for hepatic disease, or the treatment of associated disorders, that has been stable for at least 7 days prior to study drug administration is allowed if approved by the medical monitor and investigator.\n* Consumption of alcohol within 1 month before screening.\n* Consumption of caffeine-containing foods and beverages within 3 days before check-in (Day -1).\n* Consumption of Seville oranges, grapefruits, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices within 7 days before the first dose of study drug.\n* Current use of prohibited medication.\n* Receipt of live (including attenuated) vaccines or anticipation of need for such a vaccine during the study. (Note: Non-live or inactivated vaccines allowed up to 2 weeks before study drug administration.).\n* Known hypersensitivity or severe reaction to INCB161734 or excipients of INCB161734.\n* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.\n* Inability to undergo venipuncture or tolerate venous access.\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of the study data.\n* Currently smoke \\> 10 cigarettes per day, or equivalent use of other tobacco- or nicotine-containing products, and are unwilling to refrain from tobacco or nicotine use on treatment days and abide by CRU restrictions.\n* Women who are pregnant or breastfeeding.\n* New medication requirement or an increase in dose for hepatic encephalopathy within 3 months prior to check-in.\n* Current portal systemic shunt.\n* Esophageal banding within 3 months prior to check-in or required any other treatment for GI bleeding within 6 months prior to check-in. Hemorrhoidal banding is permitted.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","ALL","18 Years","80 Years",{"count":93,"type":94},24,"ESTIMATED","INTERVENTIONAL",[97],"PHASE1","This study is conducted to evaluate the pharmacokinetics and safety of INCB161734 in participants with hepatic impairment.",[100,101],"Hepatic Insufficiency","Liver Diseases",[103,104],"hepatic impairment","liver impairment (moderate and severe)","NOT_YET_RECRUITING","2026-09-25",{"date":108,"type":109},"2026-10-01","ACTUAL",{"date":111,"type":94},"2026-10-13",{"date":113,"type":94},"2027-03-31",{"name":5,"class":6}]