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NCT04472832 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Mitapivat (AG-348) in Healthy Adult Participants
A Phase 1 study, sponsored by Agios Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT04472832: Completed Phase 1 study, sponsored by Agios Pharmaceuticals.
NCT04472832 is a Phase 1 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04472832, a Phase 1 study, has completed, sponsored by Agios Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This is a Phase 1, randomized, single-dose, double-blinded, 4-period, crossover study to evaluate the pharmacokinetics, safety, and tolerability of mitapivat in healthy adult participants under fasted and fed (high-fat meal) conditions. Secondary objectives include evaluating the effect of mitapivat on electrocardiogram (ECG) parameters, including concentration-QT interval corrected for heart rate (C-QTc) analysis under fasted conditions. The study will include a 28-day screening period, four 7-day treatment periods. Participants will receive a follow-up telephone call within 28 (±1) days after the last dose of study drug.
Interventions
- DRUG Placebo for Treatment A
- DRUG Mitapivat 100 mg
- DRUG Placebo for Treatment B
- DRUG Mitapivat 300 mg
- DRUG Placebo for Treatment C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-06-17 |
| Est. Completion | 2020-11-23 |
| Phase | Phase 1 |
What the finished NCT04472832 record still lists
NCT04472832 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo for Treatment A is the first listed.
NCT04472832 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04472832 about?
NCT04472832 is a clinical study titled "A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Mitapivat (AG-348) in Healthy Adult Participants". This is a Phase 1, randomized, single-dose, double-blinded, 4-period, crossover study to evaluate the pharmacokinetics, safety, and tolerability of mitapivat in healthy adult participants under fasted and fed (high-fat meal) conditions. Secondary objectives include evaluating the effect of mitapivat...
What is the current status of trial NCT04472832?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2020-06-17. Estimated completion is 2020-11-23.
What interventions are being tested in trial NCT04472832?
The interventions under investigation include: Placebo for Treatment A (DRUG), Mitapivat 100 mg (DRUG), Placebo for Treatment B (DRUG), Mitapivat 300 mg (DRUG), Placebo for Treatment C (DRUG).
Who is sponsoring clinical trial NCT04472832?
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 NCT04472832's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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