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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
Primary Outcome
Maximum levels of drug (decitabine and tetrahydrouridine) in plasma over 24 hr
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 |
What the finished NCT05816356 record still lists
NCT05816356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05816356's enrollment target sits among peer trials
10 1035th of 1090 higher than 35 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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