A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Mitapivat (AG-348) in Healthy Adult Participants
Status:
Completed
Trial end date:
2020-11-23
Target enrollment:
Participant gender:
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.