Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * Male or female.
- * Age 18 years or above at the time of signing the informed consent.
- * Body mass index (BMI) between 18.5 and 42.0 kilogram per meter\^2 (kg/m\^2) (both inclusive) at screening.
- * Body weight greater than or equal to (\>=) 40.0 kilogram (kg) at screening.
- * Participants with chronic (above 6 months), stable (no significant deterioration in hepatic function in last 2 months as determined by the investigator) hepatic impairment classified as Child-Pugh class A, B or C, as assessed by the investigator and which is confirmed and documented by medical history, physical examination and at least one of the following: hepatic ultrasound, computerised axial tomography (CT) scan, magnetic resonance imaging (MRI), and/or liver biopsy.
- * Participants must be on a stable dose of medication and/or treatment regimen (e.g., no expectations of new medications nor changes to current medications within 14 days of dosing).
- * 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.
- * 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.
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No