Active Ingredient: ABEMACICLIB
In a single blind placebo-controlled exposure-response study in 35 healthy subjects evaluating ascending doses (200 mg to 600 mg), the concentration-deltaQTcF slopes for abemaciclib and its metabolites were not statistically different from zero. Doses up to 400 mg (twice the maximum approved daily dose) were well tolerated with no cardiac repolarization delays. At the 600 mg dose, an increased frequency of severe gastrointestinal adverse events (diarrhea, nausea) was observed without QTc changes.
https://doi.org/10.1111/cts.13573