Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment

Inclusion criteria

Inclusion Criteria for all subjects (Groups A, B, C, D) Each subject must satisfy all of the following criteria to be enrolled in the study. 1. Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted. 2. Subject is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules and other protocol requirements. 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements, including the restrictions. 4. 4\. Male, or non-pregnant and non-nursing female between ≥ 40 and ≤ 75 years of age the time of signing the ICF.. 5. Body mass index (BMI) ≥ 18 and ≤ 40 kg/m2 at screening. 6. Supine systolic blood pressure (BP): 90 to 160 mmHg, supine diastolic BP:50 to 100 mmHg, and pulse rate: 40 to 100 bpm. 7. Subject is afebrile. 8. Female subjects NOT of childbearing potential must: a. Have been surgically sterilized at least 6 months before screening, or be naturally postmenopausal. 9. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline Visits. While receiving IP and for at least 2 months after taking the last dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options. 10. Male subjects must: 1. Practice true abstinence or 2. agree to use a barrier method of birth control during sexual contact with a pregnant female or FCBP while participating in the study, during dose interruptions, and for at least 2 months after the last dose of IP, even if he has undergone a successful vasectomy. Inclusion Criteria for Subjects with mild, moderate, or severe hepatic impairment (Groups A-C) Each subject with mild, moderate, or severe hepatic impairment must also meet all the applicable criteria listed below for study entry: 11. Subject has moderate or severe hepatic impairment or cirrhosis due to chronic hepatic disease and/or prior alcohol use. 12. Subject has mild (Group A), moderate (Group B), or severe (Group C) hepatic impairment as defined by Child-Pugh Score. 1. Group A subjects must have mild hepatic impairment and are required to have documentary confirmation of the diagnosis of cirrhosis made by biopsy, laparoscopy, or imaging study with a Child-Pugh score of \< 7, at screening. 2. Group B subjects must have moderate hepatic impairment and are required to have documentary confirmation of the diagnosis of cirrhosis made by biopsy, laparoscopy, or imaging study with a Child-Pugh score of ≥ 7 to ≤ 9, at screening. 3. Group C subjects must have severe hepatic impairment. If biopsy or laparoscopy is not performed prior to screening, subject can be included only if they have chronic liver disease and objective evidence of portal hypertension (ascites diagnosis by imaging or varices), or current medication for consequences of portal hypertension. In either case a Child-Pugh score of ≥ 10 to ≤ 14 at screening is required. Subjects should be enrolled into the group corresponding to the Child-Pugh classification score that most accurately reflects the most severe hepatic disease classification within the past 6 months (based on past medical history or physical examination observation). 13. Must be medically stable for at least 1 month before screening with clinically acceptable medical history, PE, clinical laboratory tests, vital signs, and 12-lead ECGs consistent with the underlying stable mild (Group A), moderate (Group B), or severe (Group C) hepatic impairment condition, as judged by the Investigator. 14. Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition: • Subject (male or female) has a QTcF value ≤ 500 msec at screening. 15. Must be stable on a concomitant medication regimen before dosing with study drug). 16. Subjects may be treated with diuretics for ascites; however, subjects with severe ascites at time of enrollment may only be included at the discretion of the investigator with agreement of the Sponsor. 17. Subjects may have a history of encephalopathy; however, they must be on stable treatment for at least 1 month prior to screening, and must not have had an acute encephalopathic episode in the 1 months prior to screening. Inclusion Criteria for a Matched Healthy Subject (Group D) Each matched healthy subject must also meet all applicable criteria listed below for study entry: 18. Subject must be free of any clinically significant disease that would interfere with the study evaluations. 19. Subject must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the Investigator. 20. Subject in Group D must match at least one subject in Groups A-C, as needed with respect to sex, age (± 10 years), and weight (± 30 pounds). 21. Subject must be in good health as determined by past medical history, PE, vital signs, ECG, and clinical laboratory safety tests. Clinical laboratory safety tests (ie, hematology, chemistry, and urinalysis) and 12-lead ECGs must be within normal limits or clinically acceptable as judged by the Investigator. 22. Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition: 23. If male, subject has a QTcF value ≤ 450 msec at screening; 24. If female, subject has a QTcF value ≤ 470 msec at screening.