Abstract 4636: Pharmacokinetic (PK) food effect study of immediate-release onapristone and its primary metabolite (M1) in healthy female subjects: implications for design of a new formulation
Abstract:Introduction: Onapristone is an antiprogestin with demonstrated clinical activity in breast cancer, reported to have a t1/2 between 2 and 4 hours. Drugs such as megestrol acetate and abiraterone generally show variability in absorption and, depending on the formulation, food effect (≥10 x Cmax variation; ≥5 x AUC variation). A study was conducted to determine the best formulation of onapristone to minimize this variability.
Methods: The aim of this study was to determine the pharmacokinetic prof… Show more
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