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

Kowa

Status and phase: Completed; Phase 1

Conditions: Compensated Cirrhosis; Primary Biliary Cholangitis

Treatments: Drug: K-808

Study type: Interventional

Funder types: Industry

Identifiers

NCT06525311

K-808-1.01

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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):

  1. History of ALP above ULN for at least 6 months
  2. History of positive antimitochondrial antibody (AMA) titer or positive PBC-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 provide written 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 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

PBC w/o CIRR

Experimental group

Description:

K-808 single dose followed by multiple-dose treatment period.

Treatment:

Drug: K-808

PBC w/ CIRR CP-A

Experimental group

Description:

K-808 single dose followed by optional multiple-dose treatment period.

Treatment:

Drug: K-808