Primary Biliary CholangitisPhase 1NCT06525311
A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.
A Phase 1 study testing K-808 in people with Primary Biliary Cholangitis and Compensated Cirrhosis, run by Kowa Research Institute, Inc. at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cholangitis, Compensated Cirrhosis
- What is being tested?
- K-808
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 1 Oct 2024to 9 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States6 sites
Arizona Liver Health
Chandler, Arizona, 85225
Southern California Research Center, Inc
Coronado, California, 92118
Houston Research Institute
Houston, Texas, 77079
Indiana University School of Medicine - Indianapolis
Indianapolis, Indiana, 46202
Texas Liver Institute
San Antonio, Texas, 78215
Pinnacle Clinical Research
San Antonio, Texas, 782329
About this study
Official title: 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.
- Conditions
- Primary Biliary Cholangitis, Compensated Cirrhosis
- Being tested
- K-808
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-808Drug
Also called Pemafibrate
K-808 single or multi dose extended-release tablets
| Study group | Role | What they receive |
|---|---|---|
| PBC w/o CIRR | Experimental | K-808 single dose followed by multiple-dose treatment period. Receives: Drug: K-808 |
| PBC w/ CIRR CP-A | Experimental | K-808 single dose followed by optional multiple-dose treatment period. Receives: Drug: K-808 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters after a single dose of K-808: Area under the curve from 0 to infinity (AUC0-inf)
Measured: 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)
Measured: Day 1 to Day 3
PK parameters after a single dose of K-808: Observed maximum plasma concentration (Cmax)
Measured: Day 1 to Day 3
PK parameters after a single dose of K-808: Time to reach observed maximum plasma concentration (Tmax)
Measured: Day 1 to Day 3
PK parameters after a single dose of K-808: kel
Measured: Day 1 to Day 3
PK parameters after a single dose of K-808: Apparent first-order terminal elimination half-life (t½)
Measured: 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)
Measured: Day 1 to Day 3
PK parameters after a single dose of K-808: Apparent plasma clearance after extravascular administration (CL/F)
Measured: 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)
Measured: Day 1 to Day 3
PK parameters after a single dose of K-808: MRT from time 0 extrapolated to infinity (MRT0-inf)
Measured: Day 1 to Day 3
Trough concentrations after multiple dosing of K-808
Measured: 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)
Measured: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Cmax
Measured: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Tmax
Measured: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: kel
Measured: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: t½
Measured: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Vd,ss/F at steady state
Measured: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: CLss/F at steady state
Measured: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: MRT at steady state (MRTss)
Measured: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Observed accumulation ratio based on the AUC (RobsAUC)
Measured: Day 6 to Day 8
Secondary outcomes (17)
PK parameters of K-808 metabolites after a single dose: AUC0-inf
Measured: Day 1 - Day 3
PK parameters of K-808 metabolites after a single dose: AUC0-t
Measured: Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: Cmax
Measured: Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: Tmax
Measured: Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: kel
Measured: Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: t½
Measured: Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: MRT0-t
Measured: Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: MRT0-inf
Measured: Day 1 to Day 3
PK parameters at steady state after multiple dosing of K-808: AUC0- tau
Measured: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Cmax
Measured: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Tmax
Measured: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: kel
Measured: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: t½
Measured: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: (MRTss)
Measured: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: (RobsAUC)
Measured: Day 6 to Day 8
Trough concentrations after multiple dosing of K-808
Measured: Day 4 to Day 6
To assess the safety and tolerability of K-808
Measured: 5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Oct 2024
- Primary completion12 Mar 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Neville, MD, Study director, Kowa Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525311
- Sponsor's protocol ID
- K-808-1.01
- Status last verified
- May 2025
- First submitted
- 27 Jun 2024
- Last updated
- 23 May 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06525311
- Acronym / sponsor ID
- K-808-1.01
- Conditions
- Primary Biliary Cholangitis, Compensated Cirrhosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBC w/o CIRR | Experimental | Drug: K-808K-808 single dose followed by multiple-dose treatment period. |
| PBC w/ CIRR CP-A | Experimental | Drug: K-808K-808 single dose followed by optional multiple-dose treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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):
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K-808Also: PemafibrateK-808 single or multi dose extended-release tablets | Drug | PBC w/ CIRR CP-A, PBC w/o CIRR |
Primary outcome
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
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
PK parameters after a single dose of K-808: Observed maximum plasma concentration (Cmax)
Time frame: 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
PK parameters after a single dose of K-808: kel
Time frame: 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.
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
PK parameters after a single dose of K-808: Apparent plasma clearance after extravascular administration (CL/F)
Time frame: 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
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
Trough concentrations after multiple dosing of K-808
Time frame: 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
PK parameters at steady state after multiple dosing of K-808: Cmax
Time frame: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Tmax
Time frame: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: kel
Time frame: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: t½
Time frame: 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
PK parameters at steady state after multiple dosing of K-808: CLss/F at steady state
Time frame: 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
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
17 secondary outcomes
PK parameters of K-808 metabolites after a single dose: AUC0-inf
Time frame: Day 1 - Day 3
PK parameters of K-808 metabolites after a single dose: AUC0-t
Time frame: Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: Cmax
Time frame: Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: Tmax
Time frame: Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: kel
Time frame: Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: t½
Time frame: Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: MRT0-t
Time frame: Day 1 to Day 3
PK parameters of K-808 metabolites after a single dose: MRT0-inf
Time frame: 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
PK parameters at steady state after multiple dosing of K-808: Cmax
Time frame: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Tmax
Time frame: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: kel
Time frame: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: t½
Time frame: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: (MRTss)
Time frame: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: (RobsAUC)
Time frame: Day 6 to Day 8
Trough concentrations after multiple dosing of K-808
Time frame: Day 4 to Day 6
To assess the safety and tolerability of K-808
Time frame: 5 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Neville, MD study director
Kowa Research Institute, Inc.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing K-808 in people with Primary Biliary Cholangitis and Compensated Cirrhosis, run by Kowa Research Institute, Inc. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.