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Randomized, Single-dose, Crossover Study of 4 Decitabine and Tetrahydrouridine (EPI01) Formulations in Healthy Subjects

NCT03828084 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-05-09

No results posted yet for this study

Summary

To study the pharmacokinetic profiles of decitabine and tetrahydrouridine (THU) from 3 modified release formulations in healthy subjects.

Conditions

  • Healthy

Interventions

DRUG

Decitabine

Combination drugs containing decitabine and tetrahydrouridine

Sponsors & Collaborators

  • EpiDestiny, Inc.

    lead INDUSTRY

Principal Investigators

  • Cynthia A Zamora, MD · Worldwide Clinical Trials Early Phase Services, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2019-05-02
Completion
2019-05-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03828084 on ClinicalTrials.gov