AbstractQuizartinib is an oral, highly potent, and selective type II FMS‐like tyrosine kinase 3 inhibitor in development for acute myeloid leukemia. This parallel‐group study evaluated potential food effects on quizartinib absorption in healthy subjects who received a single 30‐mg dose after overnight fasting (n = 34) or a high‐fat, high‐calorie meal (n = 30). Blood samples were collected through 504 hours after dosing, and pharmacokinetic parameters calculated were maximum observed concentration (Cmax) and area under plasma concentration–time curve from time 0 to last quantifiable concentration (AUClast) and from time 0 to infinity (AUCinf). Mean quizartinib pharmacokinetic profiles were similar under fasted and fed conditions. The geometric least squares means ratios (%) for fed/fasted and associated 90% confidence intervals (CIs) for Cmax, AUClast, and AUCinf were 91.58 (82.15‐102.08), 105.39 (90.79‐122.35), and 108.39 (91.54‐128.34), respectively. The 90%CI for the ratio fell within the 80% to 125% limits for Cmax and AUClast, with 90%CI for AUCinf slightly outside the limits (ie, 128%). Food delayed quizartinib time to Cmax by 2 hours. All adverse events were either mild or moderate; no discontinuations due to adverse events occurred. Based on these results, quizartinib can be administered without regard to food.