This is an open label, 2 period, fixed-sequence study.~Twenty-two (22), healthy, adult male subjects will be enrolled; additional subjects may be enrolled to replace discontinued subjects, at the discretion of the Sponsor.~Screening of subjects will occur within 28 prior to the first dose.~On Day 1 of Period 1, a single oral dose of midazolam will be administered followed by PK sampling for midazolam and 1 OH midazolam for 24 hours.~On Day 1 of Period 2, a single oral dose of midazolam will be administered 0.75 hours after a single oral dose of entinostat. Following midazolam dosing on Day 1 of Period 2, PK samples for midazolam and 1 OH midazolam will be taken for 24 hours.~There will be a washout period of at least 7 days between the dosing in Period 1 and entinostat dose in Period 2.~Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.
The purpose of this study is to evaluate the effect of Entinostat on the bioavailability of Midazolam.~The primary objective is to evaluate the effect of a single oral dose of entinostat on the pharmacokinetics (PK) of a single oral dose of midazolam in healthy subjects.~The secondary objective is to evaluate the safety and tolerability of combined administration of entinostat and midazolam in healthy subjects.