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Effect of Food on the Pharmacokinetics of Decitabine/Tetrahydrouridine Combination Capsules in Healthy Adult Subjects

NCT04086238 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-01-22

No results posted yet for this study

Summary

This study is to investigate the effect of a high fat meal on the pharmacokinetics of decitabine and THU in healthy adults when administered as a modified release formulation of the 2 drugs in combination.

Conditions

  • Healthy

Interventions

DRUG

Decitabine

Capsules containing a combination of decitabine and THU

Sponsors & Collaborators

  • EpiDestiny, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-10-08
Primary Completion
2019-11-21
Completion
2019-11-30
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 NCT04086238 on ClinicalTrials.gov