A trial to investigate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis

A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects with Primary Biliary Cholangitis with Compensated Cirrhosis and without Cirrhosis - A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071240023

Enrollment

Registered

2024-06-19

Start date

2024-07-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cholangitis

Interventions

-K-808(DoseA)for a single dose: administrated orally -K-808(DoseB)for a single dose: administrated orally -K-808(DoseA)for a single dose followed by K-808(DoseA)for Days 1 through 6: administrated ora

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Participant has a PBC diagnosis as demonstrated by the presence of >=2 of the following three diagnostic criteria: -History of ALP above ULN for at least 6 months -History of positive antimitochondrial antibody (AMA) titer or positive PBC-specific antinuclear antibody (ANA) titers -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. -Meet all other Inclusion criteria outlined in the clinical study protocol.

Exclusion criteria

Exclusion criteria: -Female subject of childbearing potential who is known to be pregnant, has a positive pregnancy test (serum test, or urine test that is confirmed by a positive serum pregnancy test), or is lactating and breastfeeding, or planning to become pregnant or breastfeed during the study. -Subject has had ongoing conditions that may affect drug absorption such as gastroparesis, intestinal obstruction, severe gastritis, severe gastric reflux syndrome, conditions causing frequent vomiting and/or diarrhea. -Subject who has participated in another investigational drug, biologic, or medical device study within five half-lives of the agent (or within 8 weeks when half-life is unknown) prior to the first dose of study drug, or prior participation in an investigational antibody drug study within 6 months prior to the first dose of study drug. Participation in noninterventional studies (eg, observational studies, registries) is allowed. -Meet any other exclusion criteria outlined in the clinical study protocol.

Design outcomes

Primary

Measure	Time frame
-To evaluate the pharmacokinetics (PK) of K-808 in subjects with primary biliary cholangitis (PBC) without liver cirrhosis (hereinafter known as PBC w/o CIRR) and in subjects with PBC and compensated cirrhosis Child-Pugh grade A (hereinafter known as PBC w/ CIRR CP-A) including: -PK parameters after a single dose of K-808 -Trough concentrations after multiple dosing of K-808 -PK parameters at steady state after multiple dosing of K-808	—

Measure

Time frame

-To evaluate the pharmacokinetics (PK) of K-808 in subjects with primary biliary cholangitis (PBC) without liver cirrhosis (hereinafter known as PBC w/o CIRR) and in subjects with PBC and compensated cirrhosis Child-Pugh grade A (hereinafter known as PBC w/ CIRR CP-A) including: -PK parameters after a single dose of K-808 -Trough concentrations after multiple dosing of K-808 -PK parameters at steady state after multiple dosing of K-808

—

Countries

Japan, United States

Contacts

Public ContactContact for clinical trial information

Kowa Company, Ltd.

ctrdinfo@kowa.co.jp+81-3-3279-7454

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026