Healthy Volunteers Clinical Trial
Official title:
An Open-Label, 3-Part, 2-Period Study to Examine the Effect of Omeprazole (Part 1), Famotidine (Part 2), and of an Acidic Beverage (Part 3) on the Single-Dose Pharmacokinetics of Entinostat in Healthy Adult Subjects
The purpose of this study is therefore to evaluate the effect of concomitant drugs through an
increase of intra-gastric pH levels on the bioavailability of entinostat.
The primary objectives of this study are to evaluate the effect of multiple doses of
omeprazole, famotidine, and the effect of an acidic beverage in combination with omeprazole
on the single-dose PK profile of entinostat.
The secondary objectives are to evaluate the safety and tolerability of a single dose of
entinostat when administered with multiple doses of omeprazole, famotidine, and when
administered with an acidic beverage in combination with omeprazole.
This is a 3-part study. A total of 204 subjects will be dosed in this study if Parts 2 and 3
are conducted.
In Part 1, in Period 1, a single dose of entinostat will be administered. In Period 2,
multiple doses of omeprazole will be administered for 5 days with a single dose of entinostat
co-administered. If preliminary results in Period 2 of Part 1 indicate that omeprazole
exhibits clinically significant drug-drug interaction (DDI) with entinostat, then Parts 2 and
3 will be conducted. If no DDI interaction is concluded between entinostat and omeprazole in
Part 1, then neither Part 2 nor 3 will be conducted.
Part 2 will investigate the effect of multiple doses of famotidine administration on
entinostat PK. In Period 1, a single dose of entinostat will be administered. In Period 2,
oral doses of famotidine with a single dose of entinostat co-administered.
Part 3 will evaluate the effect of an acidic beverage co-administered with entinostat in
subjects with increased gastric pH due to omeprazole treatment. In Period 1, multiple oral
doses of omeprazole will be administered with a single dose of entinostat co-administered
with water. In Period 2, multiple doses of omeprazole will be administered with a single dose
of entinostat co-administered with an acidic beverage.
In all parts, PK samples will be taken.
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