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

May 22, 2025 updated by: Kowa Research Institute, Inc.

A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • Fukuoka, Japan
        • 303
      • Kita-gun, Japan
        • 302
      • Shinjuku-ku, Japan
        • 304
      • Yufu, Japan
        • 301
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Arizona Liver Health
    • California
      • Coronado, California, United States, 92118
        • Southern California Research Center, inc
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine - Indianapolis
    • Texas
      • Houston, Texas, United States, 77079
        • Houston Research Institute
      • San Antonio, Texas, United States, 78215
        • Texas Liver Institute
      • San Antonio, Texas, United States, 782329
        • Pinnacle Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PBC w/o CIRR
K-808 single dose followed by multiple-dose treatment period.
Drug: K-808
K-808 single or multi dose extended-release tablets
Other Names:
  • Pemafibrate
Experimental: PBC w/ CIRR CP-A
K-808 single dose followed by optional multiple-dose treatment period.
Drug: K-808
K-808 single or multi dose extended-release tablets
Other Names:
  • Pemafibrate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
PK parameters after a single dose of K-808: Area under the curve from 0 to infinity (AUC0-inf)
Time Frame: Day 1 - Day 3
Day 1 - Day 3
PK parameters after a single dose of K-808: Area under the curve from time 0 to last quantifiable time (AUC0-t)
Time Frame: Day 1 to Day 3
Day 1 to Day 3
PK parameters after a single dose of K-808: Observed maximum plasma concentration (Cmax)
Time Frame: Day 1 to Day 3
Day 1 to Day 3
PK parameters after a single dose of K-808: Time to reach observed maximum plasma concentration (Tmax)
Time Frame: Day 1 to Day 3
Day 1 to Day 3
PK parameters after a single dose of K-808: kel
Time Frame: Day 1 to Day 3
Day 1 to Day 3
PK parameters after a single dose of K-808: Apparent first-order terminal elimination half-life (t½)
Time Frame: Day 1 to Day 3.
Day 1 to Day 3.
PK parameters after a single dose of K-808: Apparent total volume of distribution estimated based on the terminal phase (Vd/F)
Time Frame: Day 1 to Day 3
Day 1 to Day 3
PK parameters after a single dose of K-808: Apparent plasma clearance after extravascular administration (CL/F)
Time Frame: Day 1 to Day 3
Day 1 to Day 3
PK parameters after a single dose of K-808: Mean resistance time from time 0 to last measurable concentration (MRT0-t)
Time Frame: Day 1 to Day 3
Day 1 to Day 3
PK parameters after a single dose of K-808: MRT from time 0 extrapolated to infinity (MRT0-inf)
Time Frame: Day 1 to Day 3
Day 1 to Day 3
Trough concentrations after multiple dosing of K-808
Time Frame: Day 4 - Day 6
Day 4 - Day 6
PK parameters at steady state after multiple dosing of K-808: Area under the curve over the dosing interval (AUC0-tau)
Time Frame: Day 6 to Day 8
Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Cmax
Time Frame: Day 6 to Day 8
Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Tmax
Time Frame: Day 6 to Day 8
Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: kel
Time Frame: Day 6 to Day 8
Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: t½
Time Frame: Day 6 to Day 8
Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Vd,ss/F at steady state
Time Frame: Day 6 to Day 8
Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: CLss/F at steady state
Time Frame: Day 6 to Day 8
Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: MRT at steady state (MRTss)
Time Frame: Day 6 to Day 8
Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Observed accumulation ratio based on the AUC (RobsAUC)
Time Frame: Day 6 to Day 8
Day 6 to Day 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
PK parameters at steady state after multiple dosing of K-808: Cmax
Time Frame: Day 6 to Day 8
Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Tmax
Time Frame: Day 6 to Day 8
Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: kel
Time Frame: Day 6 to Day 8
Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: t½
Time Frame: Day 6 to Day 8
Day 6 to Day 8
PK parameters of K-808 metabolites after a single dose: AUC0-inf
Time Frame: Day 1 - Day 3
Day 1 - Day 3
PK parameters of K-808 metabolites after a single dose: AUC0-t
Time Frame: Day 1 to Day 3
Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: Cmax
Time Frame: Day 1 to Day 3
Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: Tmax
Time Frame: Day 1 to Day 3
Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: kel
Time Frame: Day 1 to Day 3
Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: t½
Time Frame: Day 1 to Day 3
Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: MRT0-t
Time Frame: Day 1 to Day 3
Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: MRT0-inf
Time Frame: Day 1 to Day 3
Day 1 to Day 3
PK parameters at steady state after multiple dosing of K-808: AUC0- tau
Time Frame: Day 6 to Day 8
Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: (MRTss)
Time Frame: Day 6 to Day 8
Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: (RobsAUC)
Time Frame: Day 6 to Day 8
Day 6 to Day 8
Trough concentrations after multiple dosing of K-808
Time Frame: Day 4 to Day 6
Day 4 to Day 6
To assess the safety and tolerability of K-808
Time Frame: 5 Weeks
5 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kowa Research Institute, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sara Neville, MD, Kowa Research Institute, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K-808-1.01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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