Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.
Lead Sponsor:
Kowa Research Institute, Inc.
Conditions:
Primary Biliary Cholangitis
Compensated Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06525311
Start Date
October 1 2024
End Date
April 9 2025
Last Update
May 23 2025
Active Locations (10)
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1
Arizona Liver Health
Chandler, Arizona, United States, 85225
2
Southern California Research Center, Inc
Coronado, California, United States, 92118
3
Indiana University School of Medicine - Indianapolis
Indianapolis, Indiana, United States, 46202
4
Houston Research Institute
Houston, Texas, United States, 77079