A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.
- Registration Number
- NCT06525311
- Lead Sponsor
- Kowa Research Institute, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PBC w/o CIRR K-808 K-808 single dose followed by multiple-dose treatment period. PBC w/ CIRR CP-A K-808 K-808 single dose followed by optional multiple-dose treatment period.
- Primary Outcome Measures
Name Time Method 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: Mean resistance time from time 0 to last measurable concentration (MRT0-t) Day 1 to Day 3 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 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: Area under the curve from 0 to infinity (AUC0-inf) Day 1 - 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: kel 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 at steady state after multiple dosing of K-808: kel Day 6 to Day 8 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: 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: Tmax 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: 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 PK parameters at steady state after multiple dosing of K-808: Cmax Day 6 to Day 8
- Secondary Outcome Measures
Name Time Method 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: t½ Day 1 to Day 3 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 of K-808 metabolites after a single dose: MRT0-inf Day 1 to Day 3 PK parameters at steady state after multiple dosing of K-808: (MRTss) Day 6 to Day 8 To assess the safety and tolerability of K-808 5 Weeks 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: Tmax Day 1 to Day 3 PK parameters of K-808 metabolites after a single dose: MRT0-t Day 1 to Day 3 PK parameters at steady state after multiple dosing of K-808: (RobsAUC) Day 6 to Day 8 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: kel Day 1 to Day 3 PK parameters at steady state after multiple dosing of K-808: AUC0- tau Day 6 to Day 8 PK parameters at steady state after multiple dosing of K-808: t½ Day 6 to Day 8 Trough concentrations after multiple dosing of K-808 Day 4 to Day 6
Trial Locations
- Locations (14)
301
🇯🇵Yufu, Japan
Arizona Liver Health
🇺🇸Chandler, Arizona, United States
Southern California Research Center, Inc
🇺🇸Coronado, California, United States
Elixia EPCT
🇺🇸Hollywood, Florida, United States
Indiana University School of Medicine - Indianapolis
🇺🇸Indianapolis, Indiana, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Houston Research Institute
🇺🇸Houston, Texas, United States
Pioneer Research Solutions
🇺🇸Houston, Texas, United States
Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Pinnacle Clinical Research
🇺🇸San Antonio, Texas, United States
303
🇯🇵Fukuoka, Japan
302
🇯🇵Kita-gun, Japan
304
🇯🇵Shinjuku-ku, Japan