Who is sponsoring NCT04472832?

NCT04472832 is sponsored by Agios Pharmaceuticals, Inc..

What condition does NCT04472832 study?

NCT04472832 studies Healthy Volunteers.

What drugs are being tested in NCT04472832?

Interventions: Placebo for Treatment A, Mitapivat 100 mg, Placebo for Treatment B, Mitapivat 300 mg, Placebo for Treatment C.

What is the status of NCT04472832?

NCT04472832 is currently COMPLETED.

Last reviewed 2021-02-18 · How we verify

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

NCT04472832 PHASE1 COMPLETED

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.

Details

Lead sponsor	Agios Pharmaceuticals, Inc.
Phase	PHASE1
Status	COMPLETED
Enrolment	32
Start date	Wed Jun 17 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Nov 23 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Healthy Volunteers

Interventions

Placebo for Treatment A
Mitapivat 100 mg
Placebo for Treatment B
Mitapivat 300 mg
Placebo for Treatment C

Countries

United States