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NCT03187015 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy Volunteer and Drug Interaction, sponsored by Syndax Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target
1
Study location

NCT03187015 is a Phase 1 study of Healthy Volunteer and Drug Interaction that has completed, run by Syndax Pharmaceuticals. The registered enrollment target is 26 participants, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03187015, a Phase 1 study of Healthy Volunteer and Drug Interaction, has completed, sponsored by Syndax Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target
1
Study location

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.

Interventions

  • DRUG Midazolam
  • DRUG Entinostat

Study Locations (1)

Nebraska

  • Celerion - Lincoln

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2017-05-23
Est. Completion 2017-08-22
Phase Phase 1

Sponsor

Syndax Pharmaceuticals

25 total trials

What the Registry Record Tells You About NCT03187015

The ClinicalTrials.gov registry entry for NCT03187015 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (87% lower). The listed sponsor is Syndax Pharmaceuticals, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions - of which Midazolam is the first listed.

NCT03187015 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.

Frequently Asked Questions

What is clinical trial NCT03187015 about?

NCT03187015 is a clinical study titled "A Study to Examine the Effects of Entinostat on 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...

What is the current status of trial NCT03187015?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2017-05-23. Estimated completion is 2017-08-22.

What conditions does trial NCT03187015 study?

This clinical trial studies the following conditions: Healthy Volunteer, Drug Interaction.

What interventions are being tested in trial NCT03187015?

The interventions under investigation include: Midazolam (DRUG), Entinostat (DRUG).

Who is sponsoring clinical trial NCT03187015?

This trial is sponsored by Syndax Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03187015 being conducted?

This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.