A Comparison of Safety and Pharmacokinetics of Esuberaprost (BPS-314d-MR) in Subjects with Normal, Mild and Moderate Hepatic Impairment

ACCP 2016 -- The prostacyclin analogue beraprost (BPS) consists of a mixture of 4 stereoisomers and is available for treatment of PAH in Japan and other Asian countries. The pharmacologically active isomer esuberaprost (BPS-314d) exerts its pharmacologic actions by specifically binding to PGI2 receptors on smooth muscle, vascular endothelium, and platelets. This leads to vasodilatation, inhibition of platelet aggregation, and antiproliferation. Esuberaprost is undergoing clinical evaluation in an ongoing Phase 3 study in USA and Israel. To date, no clinical investigations have been conducted with BPS in subjects with hepatic impairment. This study investigated the PK and safety of BPS-314d-MR tablets in subjects with Child-Pugh Class A or B hepatic impairment, in comparison to subjects with normal hepatic function.