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NCT03813186 · ClinicalTrials.gov registry record · Phase 1
Effect of Food on Blood Levels of ASTX727
A Phase 1 study, sponsored by Astex Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT03813186: Completed Phase 1 study, sponsored by Astex Pharmaceuticals.
NCT03813186 is a Phase 1 study that has completed, run by Astex Pharmaceuticals. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03813186, a Phase 1 study, has completed, sponsored by Astex Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This study is designed to examine blood levels of ASTX727, a fixed-dose combination tablet containing the combination of cedazuridine (100 mg) and decitabine (35 mg), when given under fed versus fasted conditions to participants with myelodysplastic syndromes (MDS), including refractory anemia with excess blasts in transformation or chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML). This study will also assess the safety of ASTX727.
Primary Outcome
Area under the concentration-time curve from time 0 to t hours.
Interventions
- DRUG ASTX727 + Day 2 Food
- DRUG ASTX727 + Day 4 Food
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-11-08 |
| Est. Completion | 2019-12-16 |
| Phase | Phase 1 |
What the finished NCT03813186 record still lists
NCT03813186 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which ASTX727 + Day 2 Food is the first listed.
NCT03813186 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03813186 about?
NCT03813186 is a clinical study titled "Effect of Food on Blood Levels of ASTX727". This study is designed to examine blood levels of ASTX727, a fixed-dose combination tablet containing the combination of cedazuridine (100 mg) and decitabine (35 mg), when given under fed versus fasted conditions to participants with myelodysplastic syndromes (MDS), including refractory anemia with ...
What is the current status of trial NCT03813186?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2018-11-08. Estimated completion is 2019-12-16.
What interventions are being tested in trial NCT03813186?
The interventions under investigation include: ASTX727 + Day 2 Food (DRUG), ASTX727 + Day 4 Food (DRUG).
Who is sponsoring clinical trial NCT03813186?
This trial is sponsored by Astex Pharmaceuticals, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03813186's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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
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