Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shionogi
Age
18–80
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Body weight ≥50 kilograms (kg) and body mass index (BMI) within the range of ≥18.5 to \<38.0 kilogram-meter squared (kg/m\^2) at the Screening visit.
Participants With Hepatic Impairment
A diagnosis of clinically stable hepatic disease for at least 1 month prior to the Screening visit, confirmed by medical history or previous confirmation of hepatic cirrhosis by liver biopsy or medical imaging technique (including laparoscopy, computerized tomography \[CT\] scan, magnetic resonance imaging \[MRI\], or ultrasonography).
Mild or moderate hepatic impairment based on the Child-Pugh classification score at the Screening visit to determine eligibility:
1. Mild (Class A) hepatic impairment (Child-Pugh classification score 5 to 6)
2. Moderate (Class B) hepatic impairment (Child-Pugh classification score 7 to 9)
A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of study intervention through the Follow-up/Early Termination visit.
Healthy Participants
Matched to each participant with moderate (and mild when possible) hepatic impairment with respect to sex, age (± 5 years), and BMI (± 10%).
You may not be if
History or presence of/significant history of or current cardiovascular, respiratory, renal, gastrointestinal (GI), endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
History of GI surgery including but not limited to gastric resection and/or intestinal resection that resulted in a clinically significant abnormality in GI function.
Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
