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.
Age range
18 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
PK parameters after a single dose of K-808: Area under the curve from 0 to infinity (AUC0-inf)
Timeframe: 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)
Timeframe: Day 1 to Day 3
PK parameters after a single dose of K-808: Observed maximum plasma concentration (Cmax)
Timeframe: Day 1 to Day 3
PK parameters after a single dose of K-808: Time to reach observed maximum plasma concentration (Tmax)
Timeframe: Day 1 to Day 3
PK parameters after a single dose of K-808: kel
Timeframe: Day 1 to Day 3
PK parameters after a single dose of K-808: Apparent first-order terminal elimination half-life (t½)
Timeframe: 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)
Timeframe: Day 1 to Day 3
PK parameters after a single dose of K-808: Apparent plasma clearance after extravascular administration (CL/F)
Timeframe: 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)
Timeframe: Day 1 to Day 3
PK parameters after a single dose of K-808: MRT from time 0 extrapolated to infinity (MRT0-inf)
Timeframe: Day 1 to Day 3
Trough concentrations after multiple dosing of K-808
Timeframe: 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)
Timeframe: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Cmax
Timeframe: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Tmax
Timeframe: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: kel
Timeframe: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: t½
Timeframe: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Vd,ss/F at steady state
Timeframe: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: CLss/F at steady state
Timeframe: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: MRT at steady state (MRTss)
Timeframe: Day 6 to Day 8
PK parameters at steady state after multiple dosing of K-808: Observed accumulation ratio based on the AUC (RobsAUC)
Timeframe: Day 6 to Day 8