A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.
NCT Number: NCT06525311
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Primary Biliary Cholangitis|Compensated Cirrhosis
Interventions: DRUG: K-808
Sponsor: Kowa Research Institute, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-04

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.

Primary Outcome Measures: 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 Outcome Measures: 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|PK parameters of K-808 metabolites after a single dose: t½, Day 1 to Day 3|PK parameters of K-808 metabolites after a single dose: MRT0-t, Day 1 to Day 3|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: 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: (MRTss), Day 6 to Day 8|PK parameters at steady state after multiple dosing of K-808: (RobsAUC), Day 6 to Day 8|Trough concentrations after multiple dosing of K-808, Day 4 to Day 6|To assess the safety and tolerability of K-808, 5 Weeks