A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function

Exclusion Criteria

• •1. Presence of any condition or circumstance that prevents the subject from understanding and signing the ICF.
• •2. Presence or history of any disorder that may prevent the successful completion of the study.
• •3. History of significant hypersensitivity, intolerance, or allergy to food, or any medical product or relevant excipient, unless approved by the Investigator.
• •4. History of allergy to Elacestrant or drugs in a similar pharmacology class (selective ER modulator or SERD) or excipients used in the formulations of these drugs.
• •5. History of stomach or intestinal surgery or resection, or any significant gastrointestinal disease (eg, Crohn's disease) that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). Cholecystectomy will be allowed at the discretion of the Investigator.
• •6. Acute disease state (eg, nausea, vomiting, fever, diarrhea) within 14 days prior to check-in.
• •7. History of drug/chemical abuse within 1 year prior to check-in.
• •8. History of alcohol abuse within 3 months prior to screening and/or consume \> 21 units per week for males and \> 14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1 1⁄2 oz (45 mL) liquor, or 5 oz (150 mL) wine.
• •9. Positive drug screen at screening, or positive alcohol or drug screen at check-in.
• •10. Participation in a clinical study involving administration of an investigational drug (new chemical entity) or device in the past 28 days or 5 half-lives (whichever is longer) prior to dosing.
• •11. Received Elacestrant within 60 days prior to dosing.
• •12. Corrected value of the interval between the Q and T waves on the ECG tracing, using Fridericia's formula, is \> 450 ms (for healthy males) or \> 470 ms (for healthy females), is \> 470 ms (for hepatic impairment males) or \> 480 ms (for hepatic impairment females); or has ECG findings deemed abnormal with clinical significance by the Investigator at screening. ECGs will be collected in triplicate.
• •13. Use of any drugs or herbal remedies known to be strong or moderate inhibitors or inducers of CYP3A enzymes for 28 days prior to dosing or 5 half-lives (whichever is longer) and throughout the study.
• •14. Not willing to follow on-study diet requirements.
• •15. Ingestion of Seville orange- or grapefruit- containing foods or beverages within 28 days prior to check-in.
• •16. Receipt of blood products within 2 months prior to check-in.
• •17. Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
• •18. Poor peripheral venous access.
• •19. Subjects who, in the opinion of the Investigator, should not participate in this study.
• •20. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal, neurological, or psychiatric disorder.
• •21. Unable to refrain from or anticipate the use of any non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to dosing and throughout the study.
• •NOTE: After check-in, acetaminophen (up to 2 g per 24 hours), and 1% hydrocortisone cream may be administered at the discretion of the Investigator.
• •22. Unable to refrain from or anticipate the use of any prescription medications within 28 days prior to dosing or 5 half-lives (whichever is longer) and throughout the study, unless approved by the Investigator and the study assigned medical monitor.
• •NOTE: slow-release medications / products considered to still be active prior to check-in must be approved by the Investigator and the study assigned medical monitor.
• •23. Positive hepatitis B panel test and/or positive hepatitis C RNA test. Subjects whose results are compatible with prior immunization may be included.
• •24. History of diabetes mellitus.
• •25. Grade 3 and Grade 4 encephalopathy as determined by the CP score.
• •26. Portal systemic shunt.
• •27. Subject has shown evidence of hepatorenal syndrome or abnormal serum creatinine levels (above upper limit for the local lab) and estimated glomerular filtration rate \< 60 mL/min or abnormal sodium and potassium levels. The determination of the severity and clinical relevance of the latter 2 abnormalities will be at the discretion of the Investigator.
• •28. Treatment for gastrointestinal bleeding within the 3 months prior to check-in.
• •29. New medication or a change in dose for hepatic encephalopathy within the 3 months prior to check-in, unless approved by the Investigator and the study assigned medical monitor.