A Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Sitravatinib

Exclusion Criteria

• •Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator.
• •History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications (Cholecystectomy is not allowed.).
• •Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives prior to dosing, whichever is longer.
• •Participants who, in the opinion of the investigator, should not participate in this study.
• •Participants with normal hepatic function will be excluded from the study if any of the following criteria are applicable:
• •Significant history or clinical manifestation of any hepatic disease, as determined by lab abnormalities: AST, ALT, alkaline phosphatase, or alpha-fetoprotein \>1 × upper limit of normal or as deemed clinically significant by the investigator.
• •Participant has creatinine clearance \<80 mL/minute as calculated by using the Cockcroft-Gault equation.
• •Use or intend to use any prescription medications/products within 14 days prior to dosing, unless deemed acceptable by the investigator, medical monitor, and sponsor.
• •Participants with hepatic impairment will be excluded from the study if any of the following criteria are applicable:
• •Ventricular dysfunction or history of risk factors for Torsades de Pointes (eg, unexplained syncope, known long QT syndrome, heart failure, and cardiomyopathy).
• •Participant has had a change in disease status within 90 days prior to the study drug administration on Day 1, as documented by the subject's medical history, deemed clinically significant by the investigator.
• •Participant has required a new medication or a change in medication dose within 2 weeks before dosing with sitravatinib.
• •Participant has a current functioning organ transplant or is waiting for an organ transplant.
• •History of unstable diabetes mellitus as evidenced by hemoglobin A1c ≥9% at screening.
• •Uncontrolled arterial hypertension (\> 150 mm Hg systolic or \>100 mm Hg diastolic) on multiple observations despite standard of care treatment.