Linerixibat Long-term Safety, and Tolerability Study (LLSAT)

This is an interventional treatment trial for Cholestasis focused on measuring Linerixibat, Cholestasis, Cholestatic pruritus, Primary biliary cholangitis, LLSAT Read More

Inclusion Criteria:

• Male and female participants must be 18 to 80 years of age inclusive, at the time of signing the informed consent in the participant's parent trial BAT117213, GLIMMER or GLISTEN.
• Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
• Participants must have completed the main treatment period in a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a) is a woman of non-childbearing potential (WONCBP) or b) is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method.
• Capable of giving signed informed consent.

Exclusion Criteria:

• Screening total bilirubin >2x upper limit of normal (ULN).
• Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >6x ULN.
• Screening estimated glomerular filtration rate (eGFR) <30 milliliters per minute per 1.73 square meter (mL/min/1.73m^2) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
• Presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites).
• Presence of actively replicating viral hepatitis B or C (Viral Hepatitis B [HBV], viral Hepatitis C [HCV]) infection), primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer.
• Current clinically significant diarrhea in the Investigator's medical opinion.
• Current symptomatic cholelithiasis or cholecystitis.
• Current diagnosis or previous diagnosis of colorectal cancer.
• Any current malignancies (including hematologic and solid malignancies).
• History of bariatric surgery with ileal bypass at any time, or any bariatric surgery performed in the past 3 years.
• Use of Obeticholic acid: within 8 weeks prior to the date of the screening visit and may not restart until after the end of the study or early study withdrawal.
• Administration of any other ileal bile acid transporter (IBAT) inhibitor in the 1 month prior to screening until after the end of the study or early study withdrawal.
• QT interval corrected (QTc) >480 millisecond (msec) at screening (12-lead ECG)
• Participants with moderate (or greater) alcohol consumption defined as more than one standard drink per day for women and two drinks per day for men.