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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 is a Phase 1 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 36 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04128787
The ClinicalTrials.gov registry entry for NCT04128787 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Agios Pharmaceuticals, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Omeprazole is the first listed.
NCT04128787 reports 0 study locations.
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.
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