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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-04-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Biliary Cholangitis Compensated Cirrhosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PBC w/o CIRR

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

Group Type EXPERIMENTAL

K-808

Intervention Type DRUG

K-808 single or multi dose extended-release tablets

PBC w/ CIRR CP-A

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

Group Type EXPERIMENTAL

K-808

Intervention Type DRUG

K-808 single or multi dose extended-release tablets

Interventions

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K-808

K-808 single or multi dose extended-release tablets

Intervention Type DRUG

Other Intervention Names

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Pemafibrate

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No