NCT03187015

A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects

An Open Label, 2-Period Study to Assess the Effect of Entinostat on the Pharmacokinetics of Midazolam in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Syndax Pharmaceuticals · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Drug Interaction
• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Entinostat	HDAC (histone deacetylase inhibitor)
DRUG	Midazolam	benzodiazepine central nervous system (CNS) depressant

Timeline

• Start date: 2017-05-23
• Primary completion: 2017-06-04
• Completion: 2017-08-22
• First posted: 2017-06-14
• Last updated: 2018-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study