A Research Study on Etavopivat in Participants With and Without Liver Disease

Exclusion Criteria

• •Known or suspected hypersensitivity to study intervention or related products.
• •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods.
• •Participation (i.e., signed informed consent) in any interventional clinical study within 30 days or 5 times the half-life of the previous investigational medical product (IMP) (if known), whichever is longer, before screening.
• •Any disorder, unwillingness or inability, except for conditions associated with hepatic impairment in the group of participants with compromised hepatic function, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• •Participant is unable to refrain from or anticipates the use of, for 7 days prior to dosing and throughout the study, any drug known to be:
• •* an inhibitor of uridine 5'-diphospho-glucuronosyltransferase (UGT) 2B7,
• •* a strong inhibitor of cytochrome P450 (CYP)3A4 or CYP2C9,
• •* a potent inhibitor of permeability glycoprotein (P-gp).
• •Participant is unable to refrain from or anticipates the use of, for 28 days prior to dosing and throughout the study, any drug known to be:
• •* an inducer of UGT2B7,
• •* a strong or moderate inducer of CYP3A4, including St. John's Wort,
• •* a strong inducer of CYP2C9,
• •* a potent inducer of P-gp.
• •Participant is unable to refrain from or anticipates the use of any medications or substances prohibited in the study.
• •Specific exclusion criterion only for participants with hepatic impairment:
• •\- Clinical signs of an acute hepatitis (viral as well as non-viral) or positive tests of hepatitis B virus surface antigen (HBsAg) (unless hepatitis B virus titre is negative) or antibody tests of hepatitis C virus (HCV-Ab) (unless negative polymerase chain reaction \[PCR\] for hepatitis C virus).
• •Diagnostic test results positive for hepatitis B or hepatitis C infection.
• •History of diabetes mellitus or glycated haemoglobin (HbA1c) greater than or equal to 5 percent (48 millimoles per mole \[mmol/mol\]) at screening.