Transition from Syringe to Autoinjector Based on Bridging Pharmacokinetics and Pharmacodynamics of the P2Y12 Receptor Antagonist Selatogrel in Healthy Subjects

Authors: Zenklusen I, Hsin CH, Schilling U, Kankam M, Krause A, Ufer M, Dingemanse J
Publication: Clinical Pharmacokinetics
Keywords: noncompartmental analysis, pharmacodynamic, pharmacodynamics, pharmacokinetics (PK), PK/PD modeling

Abstract

Selatogrel is a potent, reversible, and selective antagonist of the platelet P2Y12 receptor currently developed for the treatment of acute myocardial infarction (AMI). In the completed Phase I/II studies, selatogrel was subcutaneously (s.c.) administered as a lyophilizate-based formulation by syringe by a healthcare professional. In the Phase III study, selatogrel will be self-administered s.c. as a liquid formulation with an autoinjector at the onset of AMI symptoms to shorten treatment delay. This clinical bridging study compared the pharmacokinetics (PK) of selatogrel between the different formulations.

By Isabelle Zenklusen, Chih-Hsuan Hsin, Uta Schilling, Martin Kankam, Andreas Krause, Mike Ufer, Jasper Dingemanse