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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
K-808 single or multi dose extended-release tablets
Arizona Liver Health
Chandler, Arizona, United States
Southern California Research Center, Inc
Coronado, California, United States
Indiana University School of Medicine - Indianapolis
Indianapolis, Indiana, United States
Houston Research Institute
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
301
Yufu, Japan
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
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