Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 32 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04472832
The ClinicalTrials.gov registry entry for NCT04472832 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 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 5 interventions - of which Placebo for Treatment A is the first listed.
NCT04472832 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.