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NCT01519011 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Pharmacokinetics, Food Effect, Safety and Efficacy of Oral Azacitidine
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01519011: Completed Phase 1 study, sponsored by Celgene.
NCT01519011 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01519011, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the pharmacokinetics of oral azacitidine when administered once daily as two 150-mg tablets, including the effect of food, and to evaluate the bioavailability of oral azacitidine 300-mg when administered as two 150-mg tablets relative to three 100-mg tablets.
Primary Outcome
PK-Area under the plasma concentration time curve (AUC)
Interventions
- DRUG oral azacitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-02-07 |
| Est. Completion | 2015-05-12 |
| Phase | Phase 1 |
What the finished NCT01519011 record still lists
NCT01519011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which oral azacitidine is the first listed.
NCT01519011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01519011 about?
NCT01519011 is a clinical study titled "Study to Evaluate Pharmacokinetics, Food Effect, Safety and Efficacy of Oral Azacitidine". The primary purpose of this study is to evaluate the pharmacokinetics of oral azacitidine when administered once daily as two 150-mg tablets, including the effect of food, and to evaluate the bioavailability of oral azacitidine 300-mg when administered as two 150-mg tablets relative to three 100-mg ...
What is the current status of trial NCT01519011?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2012-02-07. Estimated completion is 2015-05-12.
What interventions are being tested in trial NCT01519011?
The interventions under investigation include: oral azacitidine (DRUG).
Who is sponsoring clinical trial NCT01519011?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01519011's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 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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