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NCT04128787 · ClinicalTrials.gov registry record · Phase 1
A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881
A Phase 1 study, sponsored by Agios Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT04128787: Completed Phase 1 study, sponsored by Agios Pharmaceuticals.
NCT04128787 is a Phase 1 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04128787, a Phase 1 study, has completed, sponsored by Agios Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the single-dose pharmacokinetics (PK) of two formulations (Formulation 1 and Formulation 2) of AG-881 and to examine the effect of food and multiple-dose omeprazole on the single-dose PK of AG-881 Formulation 2 in healthy adult participants. This study will also assess the safety and tolerability of single-dose AG-881 (Formulation 1 and 2) alone and of AG-881 Formulation 2 when administered with and without food and when coadministered with omeprazole in healthy adult subjects.
Interventions
- DRUG Omeprazole
- DRUG AG881 Formulation 1
- DRUG AG881 Formulation 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2019-12-18 |
| Phase | Phase 1 |
What the finished NCT04128787 record still lists
NCT04128787 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Omeprazole is the first listed.
NCT04128787 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04128787 about?
NCT04128787 is a clinical study titled "A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881". The purpose of this study is to compare the single-dose pharmacokinetics (PK) of two formulations (Formulation 1 and Formulation 2) of AG-881 and to examine the effect of food and multiple-dose omeprazole on the single-dose PK of AG-881 Formulation 2 in healthy adult participants. This study will al...
What is the current status of trial NCT04128787?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2019-09-30. Estimated completion is 2019-12-18.
What interventions are being tested in trial NCT04128787?
The interventions under investigation include: Omeprazole (DRUG), AG881 Formulation 1 (DRUG), AG881 Formulation 2 (DRUG).
Who is sponsoring clinical trial NCT04128787?
This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04128787's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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