Clinical Research Directory

Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Aged 18 to 85 years, inclusive, at the time of signing the ICF. * Severe renal impairment or ESRD based on CKD-EPI (National Kidney Foundation). • 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). * 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. * BMI of 18.0 to 43.0 kg/m2 (inclusive) at screening. * Ability to swallow and retain oral tablets. * Willingness to avoid pregnancy, breastfeeding, or fathering children. Exclusion Criteria: * History of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, or neurological disease within 6 months before screening. * 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: * Recent myocardial infarction (within 6 months before check-in). * New York Heart Association Class III or IV congestive heart failure. * Unstable angina (within 6 months before check-in). * Clinically significant (symptomatic) cardiac arrhythmias (eg, sustained ventricular tachycardia, second or third degree atrioventricular block without a pacemaker). * Uncontrolled hypertension. * Participants who have a current, functioning organ transplant or are on the national transplant list and expected to receive a transplant within 3 months. * History of an autoimmune disease diagnosis (eg, myasthenia gravis). * 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). * 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. * Presence or history of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis). * 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. * Current or recent (within 3 months before screening) clinically significant GI disease or surgery (including cholecystectomy \[\< 2 months\]; excluding appendectomy and hernia repair) that could affect the absorption of study drug. * Confirmed resting pulse rate (up to 2 consecutive measurements) \< 40 bpm or \> 100 bpm at screening. * Participants with laboratory values outside the accepted range for participants with severe renal impairment or ESRD at screening. * Any major surgery within 4 weeks before screening. Note: This does not include procedure for HD. * Blood transfusion within 4 weeks before check-in (Day -1). * Chronic or current active infectious disease (including latent tuberculosis) requiring systemic antibiotic, antifungal, or antiviral treatment. * Positive test result for HBV, HCV, or HIV. Upon testing, HBV DNA and HCV RNA must be undetectable. * 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. * 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. * 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. * Medical or self-reported history of alcoholism within 3 years before screening. * 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. * 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. * 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). * Active infection requiring systemic therapy. * History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator. * Known hypersensitivity or severe reaction to INCB161734, any excipients of INCB161734, or any KRAS inhibitors (refer to the IB). * Inability to undergo venipuncture or tolerate venous access, or inadequate veins for repeat venipuncture or venous access as determined by the investigator. * Tobacco or nicotine-containing product use of \> 10 cigarettes per day within 1 month before screening. * Use of prescription drugs (including hormonal contraceptives) within 14 days before study drug administration or nonprescription medications/products (including megadose vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations as well as pre/probiotics) within 7 days of study drug administration * Note 1: Occasional acetaminophen, standard-dose ibuprofen, and standard-dose vitamins are permitted. * 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. * Participants who are pregnant or lactating. * Excessive exercise (eg, Ironman, bi/triathlon) within 3 months before screening. * 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. * Participants who have a history of paracentesis within 3 months prior to check-in. * Participants who required new medication or an increase in dose for renal disease within 3 months prior to check-in. * 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. * Esophageal banding within 3 months prior to check-in or required any other treatment for GI bleeding within 6 months prior to check-in. Other protocol-defined Inclusion/Exclusion Criteria may apply.