[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658770":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":24,"armGroups":31,"interventions":42,"overallOfficials":48,"centralContacts":52,"locations":24,"responsibleParty":62,"collaborators":24,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":24,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":89,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":24},{"fullName":5,"class":6},"Incyte Corporation","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":24},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"PK for plasma INCB161734: Cmax","Defined as the maximum plasma concentration.","Up to approximately 3.5 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],{"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 3.5 months and 30 days",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE",[32,38],{"label":33,"type":34,"description":35,"interventionNames":36},"Group 1: Severe renal impairment","EXPERIMENTAL","Participants with severe renal impairment will be enrolled in Group 1.",[37],"Drug: INCB161734",{"label":39,"type":34,"description":40,"interventionNames":41},"Group 2: End-stage renal disease (ESRD)","Participants with end-stage renal disease will be enrolled in Group 2.",[37],[43],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":24},"DRUG","INCB161734","single dose administered orally",[33,39],[49],{"name":50,"affiliation":5,"role":51},"Incyte Medical Monitor","STUDY_DIRECTOR",[53,58],{"name":54,"role":55,"phone":56,"phoneExt":24,"email":57},"Incyte Corporation Call Center (US)","CONTACT","1.855.463.3463","medinfo@incyte.com",{"name":59,"role":55,"phone":60,"phoneExt":24,"email":61},"Incyte Corporation Call Center (ex-US)","+800 00027423","eumedinfo@incyte.com",{"type":63,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100658770","phase-1-a-study-to-evaluate-the-pharmacokinetics-and-safety-of-incb161734-in-participants-with-impaired-renal-function-and-participants-on-hemodialysis-100658770",false,"NCT07854249","A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Impaired Renal Function and Participants on Hemodialysis","A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Impaired Renal Function and Participants on Hemodialysis","Inclusion Criteria:\n\n* Ability to comprehend and willingness to sign a written ICF for the study.\n* Aged 18 to 85 years, inclusive, at the time of signing the ICF.\n* Severe renal impairment or ESRD based on CKD-EPI (National Kidney Foundation).\n\n  • Participants with impaired renal function should have stable renal function (ie, those with acute changes in renal function should not be enrolled in the study).\n* Medical findings consistent with the degree of renal 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* BMI of 18.0 to 43.0 kg\u002Fm2 (inclusive) at screening.\n* Ability to swallow and retain oral tablets.\n* Willingness to avoid pregnancy, breastfeeding, or fathering children.\n\nExclusion Criteria:\n\n* History of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, or neurological disease within 6 months before screening.\n\n  * History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including but not limited to the following:\n  * Recent myocardial infarction (within 6 months before check-in).\n  * New York Heart Association Class III or IV congestive heart failure.\n  * Unstable angina (within 6 months before check-in).\n  * Clinically significant (symptomatic) cardiac arrhythmias (eg, sustained ventricular tachycardia, second or third degree atrioventricular block without a pacemaker).\n  * Uncontrolled hypertension.\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* History of an autoimmune disease diagnosis (eg, myasthenia gravis).\n* History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure \\> 180 mm Hg or diastolic blood pressure \\> 110 mm Hg at screening, confirmed by repeat testing).\n* Participants who have a 12-lead ECG abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.\n* Presence or history of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).\n* History of malignancy within 5 years before screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.\n* Current or recent (within 3 months before screening) clinically significant GI disease or surgery (including cholecystectomy \\[\\\u003C 2 months\\]; excluding appendectomy and hernia repair) that could affect the absorption of study drug.\n* Confirmed resting pulse rate (up to 2 consecutive measurements) \\\u003C 40 bpm or \\> 100 bpm at screening.\n* Participants with laboratory values outside the accepted range for participants with severe renal impairment or ESRD at screening.\n* Any major surgery within 4 weeks before screening. Note: This does not include procedure for HD.\n* Blood transfusion within 4 weeks before check-in (Day -1).\n* Chronic or current active infectious disease (including latent tuberculosis) requiring systemic antibiotic, antifungal, or antiviral treatment.\n* Positive test result for HBV, HCV, or HIV. Upon testing, HBV DNA and HCV RNA must be undetectable.\n\n  * Note 1: Participants with no prior history of HBV infection who have been vaccinated against HBV and who have a positive HBsAg antibody test as the only evidence of prior exposure may participate in the study.\n  * Note 2: Participants who have cleared a prior HBV infection (defined as HbsAg negative, HBsAb positive, or HBcAb positive) may be included at the discretion of the investigator.\n* Receipt of any vaccine including but not limited to live (including attenuated), influenza, and SARS-CoV-2 vaccines within 3 months before the first dose of study drug.\n* Medical or self-reported history of alcoholism within 3 years before screening.\n* History of significant alcohol use, defined as regular alcohol consumption \\> 21 units per week for males and \\> 14 units for females, within 3 months before screening.\n* Treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with another investigational medication or current enrollment in another investigational drug study.\n* Treatment within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug with an inducer or inhibitor of CYP3A4, P-gp, or BCRP (refer to the Drug Interaction Database Program for prohibited drugs).\n* Active infection requiring systemic therapy.\n* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.\n* Known hypersensitivity or severe reaction to INCB161734, any excipients of INCB161734, or any KRAS inhibitors (refer to the IB).\n* Inability to undergo venipuncture or tolerate venous access, or inadequate veins for repeat venipuncture or venous access as determined by the investigator.\n* Tobacco or nicotine-containing product use of \\> 10 cigarettes per day within 1 month before screening.\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 of study drug administration\n\n  * Note 1: Occasional acetaminophen, standard-dose ibuprofen, and standard-dose vitamins are permitted.\n  * Note 2: Established therapy for renal 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* Participants who are pregnant or lactating.\n* Excessive exercise (eg, Ironman, bi\u002Ftriathlon) within 3 months 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* Esophageal banding within 3 months prior to check-in or required any other treatment for GI bleeding within 6 months prior to check-in.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","ALL","18 Years","85 Years",{"count":75,"type":76},24,"ESTIMATED","INTERVENTIONAL",[79],"PHASE1","This study is conducted to evaluate the pharmacokinetics and safety of INCB161734 in participants with impaired renal function and participants on hemodialysis.",[82,83],"Renal Insufficiency","Kidney Diseases",[85,86,87,88],"renal impairment","hemodialysis","Kidney failure","end-stage renal disease","NOT_YET_RECRUITING","2026-09-28",{"date":92,"type":93},"2026-10-02","ACTUAL",{"date":95,"type":76},"2026-10-26",{"date":97,"type":76},"2027-03-30",{"name":5,"class":6}]