An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)

Exclusion Criteria

• •1. Clinically significant or history of acute or chronic liver disease of an etiology other than PBC
• •2. Patients with a diagnosis of overlapping PBC and autoimmune hepatitis
• •3. History, evidence, or high suspicion of hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms.
• •4. Presumptive or diagnosed infection that requires systemic therapy within 12 weeks of Screening and through Day 1
• •5. Female subjects who are pregnant or nursing
• •6. Screening ECG that demonstrates a QT interval ≥ 500 msec, or any other significant ECG finding with clinically significant abnormalities as determined by the Investigator
• •7. Positive for HBsAg, HCV RNA, or anti HIV antibody
• •8. Any non-hepatic acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in the study or compromise the integrity of the data
• •9. Has experienced an illness that is considered by the Investigator to be clinically significant within 2 weeks before administration of investigational product
• •10. Clinically relevant drug or alcohol abuse within 6 months of Screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication
• •11. Use of obeticholic acid (OCA), any drug of the same class, or fibrates (e.g., bezafibrate, fenofibrate, elafibranor, lanifibranor, pemafibrate, saroglitizar) within 30 days of Baseline
• •12. Use of an experimental or unapproved treatment for PBC within 30 days of Baseline
• •13. Clinically evident complication(s) of cirrhosis and portal hypertension that required either emergency room visit, hospital admission or both during the 12 week period prior to investigational product administration