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

NCT03187015 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-08-16

No results posted yet for this study

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.

Conditions

  • Drug Interaction
  • Healthy Volunteer

Interventions

DRUG

Entinostat

HDAC (histone deacetylase inhibitor)

DRUG

Midazolam

benzodiazepine central nervous system (CNS) depressant

Sponsors & Collaborators

Principal Investigators

  • James Carraher, MD · Celerion

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-23
Primary Completion
2017-06-04
Completion
2017-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03187015 on ClinicalTrials.gov