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NCT04086238 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by EpiDestiny.

Completed
Registry status
Phase 1
Development phase
46
Enrollment target

NCT04086238: Completed Phase 1 study, sponsored by EpiDestiny.

NCT04086238 is a Phase 1 study that has completed, run by EpiDestiny. The registered enrollment target is 46 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04086238, a Phase 1 study, has completed, sponsored by EpiDestiny.

COMPLETED
Registry status
Phase 1
Development phase
46 participants
Enrollment target

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.

Interventions

  • DRUG Decitabine

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2019-10-08
Est. Completion 2019-11-30
Phase Phase 1

Sponsor

EpiDestiny

4 total trials

What the Registry Record Tells You About NCT04086238

The ClinicalTrials.gov registry entry for NCT04086238 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EpiDestiny, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Decitabine is the first listed.

NCT04086238 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04086238 about?

NCT04086238 is a clinical study titled "Effect of Food on the Pharmacokinetics of Decitabine/Tetrahydrouridine Combination Capsules in Healthy Adult Subjects". 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.

What is the current status of trial NCT04086238?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2019-10-08. Estimated completion is 2019-11-30.

What interventions are being tested in trial NCT04086238?

The interventions under investigation include: Decitabine (DRUG).

Who is sponsoring clinical trial NCT04086238?

This trial is sponsored by EpiDestiny, which has 4 total clinical trials registered on ClinicalTrials.gov.

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

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, the data changelog, or report a data error.