A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.

Inclusion Criteria:

• Participant has a PBC diagnosis as demonstrated by the presence of ≥2 of thefollowing three diagnostic criteria (Lindor et al, 2019; Hirschfield et al, 2017):

1. History of ALP above ULN for at least 6 months

2. History of positive antimitochondrial antibody (AMA) titer or positivePBC-specific antinuclear antibody (ANA) titers

3. Historical liver biopsy consistent with PBC

• Has PBC with cirrhosis Child-Pugh grade A (well-compensated disease; score 5 to 6)at Screening. Group 2 (PBC w/ CIRR CP-A) only

• Male or female participant is ≥18 years of age at consent.

• Able to understand and comply with study requirements and procedures and providewritten informed consent.

• Meet all other inclusion criteria outlined in the clinical study protocol.

Exclusion Criteria:

• Female subject of childbearing potential who is known to be pregnant, has a positivepregnancy test (serum test, or urine test that is confirmed by a positive serumpregnancy test), or is lactating and breastfeeding, or planning to become pregnantor breastfeed during the study.

• Subject has had ongoing conditions that may affect drug absorption such asgastroparesis, intestinal obstruction, severe gastritis, severe gastric refluxsyndrome, conditions causing frequent vomiting and/or diarrhea.

• Subject who has participated in another investigational drug, biologic, or medicaldevice study within five half-lives of the agent (or within 8 weeks when half-lifeis unknown) prior to the first dose of study drug, or prior participation in aninvestigational antibody drug study within 6 months prior to the first dose of studydrug. Participation in noninterventional studies (eg, observational studies,registries) is allowed.

• Meet any other exclusion criteria outlined in the clinical study protocol.