Healthy Volunteer Clinical Trial
Official title:
An Open Label, 2-Period Study to Assess the Effect of Entinostat on the Pharmacokinetics of Midazolam in Healthy Adult Subjects
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.
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.
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