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

Completed · Phase 1

Conditions studied: Primary Biliary Cholangitis, Compensated Cirrhosis

In brief

A Trial to Investigate the Pharmacokinetics (PK) Effects and Safety Profile of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis.

Key facts

Study ID

NCT06525311

Run by

Kowa Research Institute, Inc.

People needed

17

Starts

2024-10-01

Expected to finish

2025-04-09

Last updated by the study team

2025-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has a PBC diagnosis as demonstrated by the presence of ≥2 of the following three diagnostic criteria (Lindor et al, 2019; Hirschfield et al, 2017):
• 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.
• Able to understand and comply with study requirements and procedures and provide written informed consent.
• Meet all other inclusion criteria outlined in the clinical study protocol.

You may not qualify if…

• 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.

Where it is running

• Arizona Liver Health — Chandler, Arizona, United States
• Southern California Research Center, Inc — Coronado, California, United States
• Indiana University School of Medicine - Indianapolis — Indianapolis, Indiana, United States
• Houston Research Institute — Houston, Texas, United States
• Texas Liver Institute — San Antonio, Texas, United States
• Pinnacle Clinical Research — San Antonio, Texas, United States
• 303 — Fukuoka, Japan
• 302 — Kita-gun, Japan
• 304 — Shinjuku-ku, Japan
• 301 — Yufu, Japan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.