Publication: Clinical Drug Investigation
Abstract
D-1553 (garsorasib) is a novel, selective oral KRASG12C inhibitor in development for cancer treatment. This randomized, open-label, crossover study in 14 healthy Chinese subjects evaluated the effect of a high-fat, high-calorie meal on the single-dose pharmacokinetics and safety of D-1553, with pharmacokinetic parameters derived by non-compartmental analysis using Phoenix WinNonlin. A high-fat meal produced only modest reductions in AUC (13-17%) and a slight increase in Cmax, changes not considered clinically relevant, and the drug was well tolerated under both fasting and fed conditions. The results suggest D-1553 can be administered without regard to food.
Author(s): Liu Y, Gao X, Li Y, He X, Shi Z, Zhang L, Wang Y, Shi A
Published: March 18, 2025
Phoenix WinNonlin: Confirming No Food Effect
Phoenix WinNonlin's non-compartmental analysis showed only a modest, clinically irrelevant food effect for this investigational KRAS inhibitor, supporting dosing without meal restrictions. As part of a Phoenix platform used by more than 1,600 companies across 60 countries, Phoenix WinNonlin's results can flow directly into PK Submit for CDISC-compliant submission packages.
