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NCT03991312 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Effect of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of Mitapivat Sulfate (AG-348) in Healthy Adult Participants
A Phase 1 study, sponsored by Agios Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT03991312: Completed Phase 1 study, sponsored by Agios Pharmaceuticals.
NCT03991312 is a Phase 1 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03991312, a Phase 1 study, has completed, sponsored by Agios Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Part 1 of this study will determine the effect of multiple-dose itraconazole, a strong cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) inhibitor, on the single-dose pharmacokinetic(s) (PK) of mitapivat sulfate in healthy adult participants. Part 2 of this study will determine the effect of multiple-dose rifampin, a strong CYP3A4 and P-gp inducer, on the single-dose pharmacokinetic(s) (PK) of mitapivat sulfate in healthy adult participants.
Interventions
- DRUG itraconazole
- DRUG rifampin
- DRUG mitapivat sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2019-06-20 |
| Est. Completion | 2019-09-10 |
| Phase | Phase 1 |
What the finished NCT03991312 record still lists
NCT03991312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which itraconazole is the first listed.
NCT03991312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03991312 about?
NCT03991312 is a clinical study titled "Study to Evaluate the Effect of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of Mitapivat Sulfate (AG-348) in Healthy Adult Participants". Part 1 of this study will determine the effect of multiple-dose itraconazole, a strong cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) inhibitor, on the single-dose pharmacokinetic(s) (PK) of mitapivat sulfate in healthy adult participants. Part 2 of this study will determine the effect of multi...
What is the current status of trial NCT03991312?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2019-06-20. Estimated completion is 2019-09-10.
What interventions are being tested in trial NCT03991312?
The interventions under investigation include: itraconazole (DRUG), rifampin (DRUG), mitapivat sulfate (DRUG).
Who is sponsoring clinical trial NCT03991312?
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 NCT03991312's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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