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

JRCT ID: jRCT2071240023

Registered date:19/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Primary Biliary Cholangitis
• Date of first enrollment: 17/07/2024
• Target sample size: 16
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

Primary Outcome

-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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Tanigawa Ryohei