The Effect of Food on the Pharmacokinetics of the Potassium‐Competitive Acid Blocker Vonoprazan

Abstract Herein, we report a food‐effect study of vonoprazan, an oral potassium‐competitive acid blocker. In a phase 1, randomized, open‐label, crossover study, healthy subjects received a single 20‐mg dose of vonoprazan either following an overnight fast or 30 minutes after a high‐fat breakfast. Plasma vonoprazan levels were determined at 0 hour and at 17 subsequent assessment points up to 48 hours after dosing. After a 5‐day washout, subjects received a second 20‐mg vonoprazan dose in the alternative fed/fasted state (identical process repeated). Twenty‐four subjects completed the study. Vonoprazan exposure was not meaningfully affected by food. Geometric mean ratios for maximum concentration, area under the concentration‐time curve from time 0 to 24 hours, and area under the plasma concentration–time curve extrapolated to infinity obtained under fed and fasting conditions were 1.05 (90% confidence interval, 0.98‐1.12), 1.13 (1.09‐1.18), and 1.15 (1.11‐1.19), respectively. Four subjects experienced 6 adverse events that were all mild and considered unrelated to the study drug. Vonoprazan can be administered without regard to food intake.