Randomized, Single-dose, Crossover Study of 4 Decitabine and Tetrahydrouridine (EPI01) Formulations in Healthy Subjects
Public ClinicalTrials.gov record NCT03828084. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Randomized, Single-Dose, Four-Way Crossover, Bioavailability Study of Three Formulations of Decitabine/Tetrahydrouridine (THU) Combination Modified Release Capsules (5 mg/250 mg) in Healthy and Fasting Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To study the pharmacokinetic profiles of decitabine and tetrahydrouridine (THU) from 3 modified release formulations in healthy subjects.
Study identification
- NCT ID
- NCT03828084
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 16 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2, 2019
- Primary completion
- May 1, 2019
- Completion
- May 2, 2019
- Last update posted
- May 8, 2019
2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Worldwide Clinical Trial | San Antonio | Texas | 78217 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03828084, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 8, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03828084 live on ClinicalTrials.gov.