| Eligibility |
Inclusion Criteria:
All Participants:
- Age: 18 to 75 years of age (inclusive).
- Weight greater than (>) 45 kilograms (kg) and body mass index (BMI) 18.5 - 40 kg per
square meter (kg/m^2) (inclusive).
- Male and female- A female participant is eligible to participate if she is not
pregnant or breastfeeding, and at least one of the following conditions applies; not a
woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow contraceptive
guidance during the treatment period and until at least 4 weeks after the last dose of
study treatment.
- Participant capable of giving signed informed consent.
Participants with Moderate Hepatic Impairment (Cohort 1):
- Moderate hepatic impairment (of any etiology) and clinically stable for at least 1
month prior to screening.
- Child-Pugh score of 7-9.
- Previous confirmation of liver cirrhosis confirmed by either- Liver biopsy, Imaging
technique, or Noninvasive liver assessment consistent with cirrhosis.
- Hepatic impairment needs to be chronic (>6 months), stable.
Matched Healthy Control Participants (Cohort 2):
- Participants will be matched by age plus or minus (±)10 years to a corresponding
participant in the hepatic impairment group. Age should remain between 18 and 75 years
of age (inclusive).
- Participants will be matched by total body weight ±15 percentage (%) to a
corresponding participant in the hepatic impairment group.
- Participants will be matched by gender and race to a corresponding participant in the
hepatic impairment group.
- Healthy participant as determined by the investigator or medically qualified designee
based on a medical evaluation including medical history, physical examination,
laboratory tests and ECG.
Exclusion Criteria:
All Participants:
- Participants are excluded from the study if any of the following medical conditions
apply:
- History of cholecystectomy, current symptomatic cholelithiasis or inflammatory
gallbladder disease.
- Significant history of cardiovascular, respiratory, hepatic, renal, gastrointestinal,
endocrine, 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.
- Any clinically relevant abnormality identified at the screening medical assessment
(physical examination/medical history review), clinical laboratory tests, or 12-lead
ECG.
- Current clinically significant diarrhea.
- History of gastrointestinal surgery with ileal resection or ileal bypass at any time.
- Any malignancy within the past 5 years except for basal cell or squamous cell
carcinoma of the skin disease for 3 years.
- Participants with unstable cardiac function or participants with uncontrolled
hypertension.
- Any current medical or psychiatric condition, clinical or laboratory abnormality, or
examination finding which may affect study compliance or investigational procedures or
possible consequences of the study.
- Administration of any other Ileal bile acid transport (IBAT) inhibitor (including
linerixibat) in the 3 months prior to screening.
- For healthy participants, past or intended use of over the counter or prescription
medication, including vitamins and dietary or herbal supplements) within 7 days prior
to the first dose of study medication.
- Current enrolment in a clinical trial or recent participation in a clinical trial and
has received an investigational product within the following time-period prior to
study drug administration in the current study: 30 days.
- Positive pregnancy test at screening or at Day -1 in women of childbearing potential.
- Positive human immunodeficiency virus (HIV) antibody test.
- Healthy control participant has corrected interval using the Fridericia's QT
correction formula (QTcF) >450 millisecond (msec); or participant with hepatic
impairment has a baseline QTcF >480 msec on ECG.
- Regular use of known drugs of abuse or history of drug abuse or dependence within 6
months of the study.
- Moderate (or greater) alcohol consumption defined as one standard drink per day for
women and two drinks per day for men.
- History of regular use of tobacco or nicotine-containing products.
- Positive drug/alcohol screen at Screening or at Day -1.
- Where participation in the study would result in donation of blood or blood products
more than 500 milliliter (mL) within a 56-day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Sensitivity to any of the study interventions, or components thereof, or drug or other
allergy that contraindicates participation in the study.
Participants with Hepatic Impairment (Cohort 1):
- History of gastric or oesophageal variceal bleeding within the past 6 months and for
which varices have not been adequately treated medically or endoscopically.
- Grade 3 ascites (large ascites with marked abdominal distension) refractory to medical
therapy.
- Refractory hepatic encephalopathy as judged by the investigator.
- Child-Pugh score of 10 or higher or Child-Pugh score of 6 or lower.
- Hepatopulmonary or hepatorenal syndrome and history of liver transplantation.
- Evidence of active infection, including spontaneous bacterial peritonitis.
- Confirmed hepatocellular carcinoma (HCC) or biliary cancer.
- Alanine amino transferase (ALT) value >3 x upper limit of normal (ULN).
- Platelet count less than (<) 50,000/microliter (µl).
Matched Healthy control participants (Cohort 2):
- Current or chronic history of liver disease or known hepatic or biliary abnormalities
and/or confirmed hepatocellular carcinoma or biliary cancer.
- Screening ALT or aspartate aminotransferase (AST) above the upper limit of normal
(ULN).
- Elevated bilirubin above the ULN unless this is due to underlying Gilbert's syndrome.
- Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior
to first dose of study intervention.
- Positive hepatitis C antibody ribonucleic acid (RNA) test result at screening or
within 3 months prior to first dose of study intervention.
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