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

Exclusion Criteria

• •The presence of any of the following will exclude a subject from enrollment:
• •1. Subject has any condition or circumstance that prevents the subject from understanding and signing the ICF.
• •2. Subject has any condition that places the subject at an unacceptable risk from participating in the study or would confound the ability to interpret data from the study.
• •3. Subject has any significant medical condition or psychiatric illness that would prevent the subject from participating in the study at Investigator discretion.
• •4. Subject has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, excretion, eg, bariatric procedure. Subjects with cholecystectomy and appendectomy may be included.
• •5. Subject is a pregnant or is breastfeeding.
• •6. Subject donated blood or plasma within 2 weeks before dose administration to a blood bank or blood donation center.
• •7. Subject has a history of alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual \[DSM\]) within 6 months before the first dose administration, or positive alcohol screen.
• •8. Subject has a history of drug abuse (as defined by the current version of the DSM) within 6 months before the first dose administration, or positive drug screen that is not consistent with the patient's prescribed medication and or/medical history.
• •9. Subject is known to have active serum hepatitis, or have a positive result to the test for Human immunodeficiency virus (HIV) antibodies at screening.
• •• Chronic or resolved Hepatitis B or Hepatitis C are acceptable only if sequelae are limited to hepatic involvement and its consequent comorbidities. (ie, vasculitis, clinically significant cryoglobulinemia, etc. are unacceptable).
• •10. Subject was exposed to an investigational drug (new chemical entity) within 30 days before dosing, or 5 half-lives of that investigational drug, if known (whichever is longer).
• •11. Subject used approved medications or herbal medicines that are moderate or strong cytochrome P450 (CYP)1A2 or 3A4/5 inducers and/or inhibitors (including St. John's wort) within 14 days or 5 half-lives of screening, whichever is longer.
• •• The Indiana University "Cytochrome P450 Drug Interaction Table" should be utilized to determine inhibitors and/or inducers of CYP1A2 and CYP3A4/5.
• •(http://medicine.iupui.edu/clinpharm/ddis/table.aspx).
• •12. Subject will have consumed Seville oranges, grapefruit or grapefruit juice and/or pomelos, exotic citrus fruits, or grapefruit hybrids within 14 days or 5 half-lives of dosing, whichever is longer.
• •13. Subject smokes more than 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).
• •14. Subject has a history of multiple drug allergies or drug-related anaphylaxis.
• •15. Subject has received live vaccination (excluding seasonal flu vaccination) within 90 days of dosing.
• •16. Subject is part of the staff personnel or a family member of the investigational study staff.
• •The presence of any of the following will exclude a hepatic impaired subject from enrollment:
• •18. Subject has any unstable medical condition occurring within 3 months prior to signing the ICF (excluding hepatic impairment and associated comorbidities per Investigator discretion).
• •19. Subject has any serious medical condition (excluding hepatic impairment and related complications), clinically significant laboratory abnormality not related to hepatic impairment and related complications, or psychiatric illness that would prevent the subject from signing the ICF and participating in the study per Investigator discretion.
• •20. Subject has hepatic encephalopathy with time- or place- disorientation, somnolence, stupor, rigidity, coma, no personality/behavior, rigidity, or hyperactive reflexes - or has had such within 1 month of screening.
• •21. Subject has a history of incipient/planned liver transplantation within 6 months of screening or has received a liver transplant.
• •Each matched healthy subject will be excluded from entry if ANY of the criteria listed below are met:
• •22. Subject has any clinically significant laboratory abnormality that in the opinion of the Investigator, is considered to prevent the subject from safely completing the study.
• •23. Subject has any unstable clinically significant illness within 3 months prior to the study.
• •24. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• •25. Positive testing for any active hepatitis, or history of Hepatitis B or C.