Healthy Volunteers Clinical Trial
Official title:
A 2-Stage, Open-Label, Randomized, Single-Dose, Crossover Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat in Healthy Adult Subjects
The objectives of this study are to evaluate the effect of the timing of a moderate-fat meal on the single dose pharmacokinetics of entinostat and to evaluate the safety and tolerability of entinostat under fed and fasting conditions in healthy adult subjects.
This is a 2-stage food effect (timing of the meal) study. A total of 48 subjects will be
dosed if Stage 2 is conducted.
Stage 1 will be conducted as an open-label, randomized, 2-way crossover study. On Day 1 of
each period, subjects will receive a single, oral dose of entinostat under fasting or fed
conditions.
If preliminary results in Stage 1 indicate that the timing of a meal exhibits significant
effect on the bioavailability of entinostat, then Stage 2 will be conducted which will
investigate the effect of a meal either before or after dosing of entinostat on entinostat
PK.
Stage 2 will be conducted as an open-label, randomized, 3-way crossover study. On Day 1 of
each period, subjects will receive a single, oral dose of entinostat under fasting or fed
conditions.
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