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A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects

NCT02922933 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-08-16

No results posted yet for this study

Summary

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.

Conditions

  • Volunteers
  • Healthy Volunteers
  • Human Volunteers
  • Normal Volunteers

Interventions

DRUG

entinostat

HDAC (histone deacetylase inhibitor)

DIETARY_SUPPLEMENT

Omeprazole

Proton pump inhibitor

DIETARY_SUPPLEMENT

Famotidine

Histamine-2 blocker

Sponsors & Collaborators

Principal Investigators

  • Laura Sterling, MD · Celerion

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-10-25
Primary Completion
2017-04-19
Completion
2017-05-08

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 NCT02922933 on ClinicalTrials.gov