A Phase 1 Study to Assess the Effect of Food on the Pharmacokinetics (PK) and Gastrointestinal (GI) Tolerability of Selumetinib in Adolescents with Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PN).

This article, published in the journal Neuropediatrics, discusses a phase 1 study that aimed to assess the effect of food on the pharmacokinetics and gastrointestinal tolerability of selumetinib in adolescents with neurofibromatosis type 1 (NF1)-related plexiform neurofibromas (PN). The study found that dosing selumetinib with a low-fat meal delayed absorption rate and lowered C max (maximum concentration), but had no clinically significant effect on the extent of absorption and gastrointestinal tolerability. Therefore, the study suggests that dose adjustment is unlikely required and that dosing selumetinib with a low-fat meal has no significant impact on the area under the curve (AUC) or gastrointestinal tolerability. [Extracted from the article]