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

NCT06525311 | Completed Phase 1 FDA Drug

• 1 other identifier: K-808-1.01
• Study Type: interventional
• Target: 17
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

Primary Biliary Cholangitis; Compensated Cirrhosis

Outcome Measures

Primary Outcomes (20)

• PK parameters after a single dose of K-808: Area under the curve from 0 to infinity (AUC0-inf)

  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)

  Day 1 to Day 3

• PK parameters after a single dose of K-808: Observed maximum plasma concentration (Cmax)

  Day 1 to Day 3

• PK parameters after a single dose of K-808: Time to reach observed maximum plasma concentration (Tmax)

  Day 1 to Day 3

• PK parameters after a single dose of K-808: kel

  Day 1 to Day 3

• PK parameters after a single dose of K-808: Apparent first-order terminal elimination half-life (t½)

  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)

  Day 1 to Day 3

• PK parameters after a single dose of K-808: Apparent plasma clearance after extravascular administration (CL/F)

  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)

  Day 1 to Day 3

• PK parameters after a single dose of K-808: MRT from time 0 extrapolated to infinity (MRT0-inf)

  Day 1 to Day 3

• Trough concentrations after multiple dosing of K-808

  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)

  Day 6 to Day 8

• PK parameters at steady state after multiple dosing of K-808: Cmax

  Day 6 to Day 8

• PK parameters at steady state after multiple dosing of K-808: Tmax

  Day 6 to Day 8

• PK parameters at steady state after multiple dosing of K-808: kel

  Day 6 to Day 8

• PK parameters at steady state after multiple dosing of K-808: t½

  Day 6 to Day 8

• PK parameters at steady state after multiple dosing of K-808: Vd,ss/F at steady state

  Day 6 to Day 8

• PK parameters at steady state after multiple dosing of K-808: CLss/F at steady state

  Day 6 to Day 8

• PK parameters at steady state after multiple dosing of K-808: MRT at steady state (MRTss)

  Day 6 to Day 8

• PK parameters at steady state after multiple dosing of K-808: Observed accumulation ratio based on the AUC (RobsAUC)

  Day 6 to Day 8

Secondary Outcomes (17)

• PK parameters of K-808 metabolites after a single dose: AUC0-inf

  Day 1 - Day 3

• PK parameters of K-808 metabolites after a single dose: AUC0-t

  Day 1 to Day 3

• PK parameters of K-808 metabolites after a single dose: Cmax

  Day 1 to Day 3

• PK parameters of K-808 metabolites after a single dose: Tmax

  Day 1 to Day 3

• PK parameters of K-808 metabolites after a single dose: kel

  Day 1 to Day 3

Study Arms (2)

PBC w/o CIRR

EXPERIMENTAL

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

Drug: K-808

PBC w/ CIRR CP-A

EXPERIMENTAL

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

Drug: K-808

Interventions

K-808 DRUG

K-808 single or multi dose extended-release tablets

Also known as: Pemafibrate

PBC w/ CIRR CP-A; PBC w/o CIRR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (10)

Arizona Liver Health

Chandler, Arizona, 85225, United States

Location

Southern California Research Center, Inc

Coronado, California, 92118, United States

Location

Indiana University School of Medicine - Indianapolis

Indianapolis, Indiana, 46202, United States

Location

Houston Research Institute

Houston, Texas, 77079, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Pinnacle Clinical Research

San Antonio, Texas, 782329, United States

Location

303

Fukuoka, Japan

Location

302

Kita-gun, Japan

Location

304

Shinjuku-ku, Japan

Location

301

Yufu, Japan

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sara Neville, MD

  Kowa Research Institute, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 29, 2024
• Study Start: October 1, 2024
• Primary Completion: March 12, 2025
• Study Completion: April 9, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

US (6); JP (4)