Effects of Tablet Formulation, Food, or Gastric pH on the Bioavailability of Asundexian.

ABSTRACT: Absolute bioavailability (F) and the impact of gastric pH, tablet formulation, and food on the pharmacokinetics and safety of asundexian, an oral factor XIa inhibitor, was assessed in healthy White men aged 18-45 years in 4 studies. For F, fasted participants received 50 μg of [¹³ C₇ ,¹⁵ N]-labeled asundexian intravenously 2 hours after 25 mg of asundexian orally. Tablet formulation (50-mg immediate release [IR], and different amorphous solid dispersion [ASD] IR 25-mg and 50-mg ASD IR tablets) and food effects were explored in 2 studies. Formulation was compared using 50-mg IR versus 25-mg ASD IR and 25-mg ASD IR versus 50-mg ASD IR (fasted); food effect using 25-mg ASD IR and 50-mg ASD IR. Gastric pH modulation was assessed using omeprazole or antacid coad

SUBMITTER: Kanefendt F 

PROVIDER: S-EPMC10107294 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature