A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.

Inclusion criteria

Inclusion Criteria for all subjects (Group 1, 2, 3, and 4) Each subject must satisfy all of the following criteria to be enrolled in the study: Key inclusion criteria: 1. Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted. 2. Subject is male, or non-pregnant and non-nursing female between ≥ 40 and ≤ 65 years of age at the time of signing the ICF. 3. Subject has body mass index (BMI) ≥ 18 and ≤ 40 kg/m2 at screening. 4. Subject has seated systolic blood pressure (BP): 90 to 160 mmHg, seated diastolic BP: 50 to 100 mmHg, and pulse rate: 40 to 100 bpm. 5. Female subjects NOT of childbearing potential must: a. Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone \[FSH\] level of \> 40 IU/L at screening). 6. Females of childbearing potential (FCBP)1 must have a negative pregnancy test at the Screening and Baseline Visits. While receiving IP and for at least 4 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. 7. Male subjects must: a. Practice true abstinence2 (which must be reviewed on a monthly basis and source documented) or agree to use a barrier method of birth control (condoms not made out of natural \[animal\] membrane \[latex condoms are recommended\]) during sexual contact with a pregnant female or FCBP while participating in the study, during dose interruptions, and for at least 4 months after the last dose of IP, even if he has undergone a successful vasectomy. Inclusion Criteria for Subjects with Moderate or Severe Hepatic Impairment (Groups 1 and 3) Each subject with moderate or severe renal impairment must also meet ALL of the criteria listed below for entry: 8. Subject has moderate or severe hepatic impairment or cirrhosis due to chronic hepatic disease and/or prior alcohol use. 9. Subject has moderate (Group 1), or severe (Group 3) hepatic impairment as defined by Child-Pugh Score. * Group 1 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. * Group 3 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 ≤ 13 at screening is required. 10. Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition: • Subject (male or female) has a QTcF value ≤ 480 msec at screening. 11. Must be stable in concomitant medication regimen (defined as not starting a new medication\[s\] or a change in the dosage or frequency of the concomitant medication\[s\] within 7 days or 5 half-lives \[whichever is longer\] before dosing with study drug). 12. 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. 13. 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. 14. Subjects must not have history of hepatorenal syndrome or hemolysis. Inclusion Criteria for a Matched Healthy Subject (Groups 2 and 4) Each matched healthy subject must meet ALL the criteria listed below for entry: 15. Subject must be free of any clinically significant disease that would interfere with the study evaluations. 16. Subject must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the Investigator and Celgene's Medical Monitor. 17. Subject must match a subject in Group 1 or 3, as needed with respect to sex, age (± 10 years), and weight (± 30 pounds). 18. 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. 19. Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition: 1. If male, subject has a QTcF value ≤ 450 msec at screening. 2. If female, subject has a QTcF value ≤ 470 msec at screening.