A Comparative Study of Selatogrel (ACT-246475) Formulations in Healthy Subjects

Phase 1 Completed 24 enrolled Viatris Innovation GmbH

RandomizedCrossoverOpen-labelOther

Summary

The main purpose is to study the pharmacokinetics of selatogrel (ACT-246475) using different administration modes and formulations. The clinical pharmacology data will be used to support demonstration of bioequivalence and interchangeability of the different formulations.

Timeline

Start: 2020-11-06
Primary completion: 2020-12-19
Completion: 2020-12-19

Publications

Results Zenklusen I, Hsin CH, Schilling U, Kankam M, Krause A, Ufer M, Dingemanse J. Transition from Syringe to Autoinjector Based on Bridging Pharmacokinetics and Pharmacodynamics of the P2Y12 Receptor Antagonist Selatogrel in Healthy Subjects. Clin Pharmacokinet. 2022 May;61(5):687-695. doi: 10.1007/s40262-021-01097-9. Epub 2021 Dec 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Selatogrel	Small molecule	16 mg	Subcutaneous

Indications

No indication recorded.