Clinical Research Directory

Inclusion Criteria: Participants with hepatic impairment: * Diagnosis of cirrhosis due to parenchymal liver disease * Considered to have a Child-Pugh score of 10 to 15, consistent with severe HI, and a documented medical history of liver disease. Participants must be clinically stable (no acute episodes of illness due to deterioration in hepatic function) for at least 1 month prior to screening and are likely to remain stable throughout the study. * Grade 0 or Grade 1 hepatic encephalopathy considered stable per Investigator assessment without exacerbation within the 6 months prior to screening. * Currently on a stable medication regimen, defined as not starting new drug(s) or significantly changing drug dosage(s) within 14 days preceding Day 1. * Non-hepatic abnormal laboratory values must be not clinically significant as judged by the Investigator (or designee) and the study medical monitor. * Anemia secondary to hepatic disease is acceptable if hemoglobin is ≥ 9 g/dL and anemia symptoms are not clinically significant. Platelet count must be ≥ 35,000 platelets. * QT interval corrected for heart rate using Fridericia's formula (QTcF) of ≤ 480 msec. Matched-control participants: * Healthy, with normal hepatic function with a Child-Pugh score below 5. * Resting blood pressure of 90 to 140 mmHg (systolic) and 40 to 90 mmHg (diastolic). * QTcF of ≤ 450 msec. * Participant must match hepatically impaired participants with respect to sex, race, age (±10 years), smoking status (smoke or vape ≤ 10 cigarettes/day), and body mass index (±20%). Exclusion Criteria for all participants: * Women of childbearing potential (WOCBP) who are pregnant, lactating, or planning to become pregnant within 90 days after the dose of vorasidenib. * The participant is using hormonal contraceptives * Use of any other investigational drug or device within 30 days (or 5 half-lives if known, whichever is longer) before the dose of vorasidenib * Consumption of any nutrients known to modulate CYP450 enzymes activity (e.g., grapefruit or grapefruit juice, pomelo juice, star fruit, Seville \[blood\] orange products) within 14 days before vorasidenib administration. * Consumption of alcohol-containing foods or beverages or caffeine- or xanthine-containing foods or beverages (including, but not limited to, teas \[including decaffeinated teas\], coffees \[including decaffeinated coffees\], colas \[including decaffeinated colas\], energy drinks, gum containing caffeine, and chocolate (including foods and beverages containing chocolate) within 48 hours prior to admission * Any history (within 5 years prior to screening) or presence of malignancy, except for adequately treated basal cell and squamous cell carcinoma of the skin * History within the previous 12 months of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 12 oz beer, 5 oz wine, or 1.5 oz spirits) * In the opinion of the Investigator, the participant is not suitable for entry into the study