NCT04472832

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

A Phase 1, Randomized, Four-Period, Crossover Food-Effect Study With Mitapivat Sulfate In Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Agios Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Placebo for Treatment A	6 tablets matched to mitapivat tablet
DRUG	Mitapivat 100 mg	Two 50-mg tablets
DRUG	Placebo for Treatment B	4 tablets matched to mitapivat tablet
DRUG	Mitapivat 300 mg	Six 50-mg tablets
DRUG	Placebo for Treatment C	4 tablets matched to mitapivat tablet

Timeline

• Start date: 2020-06-17
• Primary completion: 2020-11-23
• Completion: 2020-11-23
• First posted: 2020-07-15
• Last updated: 2021-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study