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NCT05816356 · ClinicalTrials.gov registry record · Phase 1
To Study the Oral Bioavailability of a New Combination Formation of Decitabine and Tetrahydrouridine in Healthy Males
A Phase 1 study of Healthy, sponsored by EpiDestiny.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05816356: Completed Phase 1 study of Healthy, sponsored by EpiDestiny.
NCT05816356 is a Phase 1 study of Healthy that has completed, run by EpiDestiny. The registered enrollment target is 10 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05816356, a Phase 1 study of Healthy, has completed, sponsored by EpiDestiny.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, randomized, single-dose per period, two-period, crossover study to evaluate the relative bioavailability of decitabine and tetrahydrouridine ingested as a modified-release combination formulation compared to THU and decitabine ingested as immediate-release capsules
Conditions Studied
Interventions
- DRUG Decitabine
- DRUG Tetrahydrouridine
Study Locations (1)
Texas
- Worldwide Clinical Trails Early Phase Services - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-03-24 |
| Est. Completion | 2023-10-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05816356
The ClinicalTrials.gov registry entry for NCT05816356 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The listed sponsor is EpiDestiny, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Decitabine is the first listed.
NCT05816356 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05816356 about?
NCT05816356 is a clinical study titled "To Study the Oral Bioavailability of a New Combination Formation of Decitabine and Tetrahydrouridine in Healthy Males". This is an open-label, randomized, single-dose per period, two-period, crossover study to evaluate the relative bioavailability of decitabine and tetrahydrouridine ingested as a modified-release combination formulation compared to THU and decitabine ingested as immediate-release capsules
What is the current status of trial NCT05816356?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-03-24. Estimated completion is 2023-10-10.
What conditions does trial NCT05816356 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT05816356?
The interventions under investigation include: Decitabine (DRUG), Tetrahydrouridine (DRUG).
Who is sponsoring clinical trial NCT05816356?
This trial is sponsored by EpiDestiny, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05816356 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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