Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-Control Participants

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 …