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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 is a Phase 1 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 28 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03991312
The ClinicalTrials.gov registry entry for NCT03991312 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 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 itraconazole is the first listed.
NCT03991312 reports 0 study locations.
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.
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