drugset
drugset / Trial / NCT04472832

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Mitapivat (AG-348) in Healthy Adult Participants

NCT04472832 ↗

Phase 1 Completed 32 enrolled Agios Pharmaceuticals, Inc.
RandomizedCrossoverTriple-blindTreatment

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.

Timeline

Start
2020-06-17
Primary completion
2020-11-23
Completion
2020-11-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Mitapivat Small molecule 100 mg Oral
Subject Mitapivat Small molecule 300 mg Oral

Indications

No indication recorded.