Background: The authors present a validated method for the simultaneous quantification of asundexian (BAY 2433334) and its pharmacologically inactive major human metabolite M-10 from human plasma and its application in clinical study sample analysis. Materials & methods: Sample preparation was performed by protein precipitation followed by reverse phase HPLC and positive/negative ESI-MS/MS. Results: Assay working ranges were 0.5-500 ng/ml for asundexian and 5.0-5000 ng/ml for M-10. Validation results met the requirements of pertinent guidelines. In clinical study sample analysis, accuracy and precision acceptance criteria for analyzed quality control samples were met and incurred sample reanalysis was fulfilled. Conclusion: The method proved to be selective, specific, sufficiently sensitive, reproducible and robust for the analysis of samples obtained from clinical trials.
Keywords: LC–MS/MS; asundexian; clinical studies; factor XIa inhibitor; quantification; thromboembolic disorders.