Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area under the concentration-time curve (AUC) from time of dosing to the last quantifiable concentration of Decitabine
Interventions
- DRUG Decitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2019-10-08 |
| Est. Completion | 2019-11-30 |
| Phase | Phase 1 |
What the finished NCT04086238 record still lists
NCT04086238 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 1 intervention - of which Decitabine is the first listed.
NCT04086238 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04086238's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01890590 · 46 participants · NA
A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
- NCT03191149 · 46 participants · Phase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
- NCT03510208 · 46 participants · Phase 1
Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
- NCT04048278 · 46 participants · Early Phase 1
Lidocaine Infusion in Pancreatic Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI