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drugset / Trial / NCT03991312

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

NCT03991312 ↗

Phase 1 Completed 28 enrolled Agios Pharmaceuticals, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-06-20
Primary completion
2019-08-14
Completion
2019-09-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule 200 mg Oral
Subject Mitapivat Small molecule 20 mg Oral
Subject Mitapivat Small molecule 50 mg Oral
Subject Rifampicin Small molecule 600 mg Oral

Indications

No indication recorded.