This is a dose escalation study that will be conducted in healthy volunteers. Multiple
cohorts of volunteers will receive ascending oral doses of AG-348 to evaluate the safety and
tolerability of a single oral dose of AG-348, the pharmacokinetics (PK) of a single dose of
AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the
blood.
This is a dose escalation study that will be conducted in healthy volunteers. Multiple
cohorts of volunteers will receive ascending (increasingly higher) oral doses of AG-348 daily
for 14 days to evaluate the safety and tolerability of multiple oral doses of AG-348, the
pharmacokinetics (PK) of multiple doses of AG-348, and the pharmacodynamic profile of AG-348
with specific biomarkers assessed in the blood.
A Study of AG-348 in Adult Participants With Pyruvate Kinase (PK) Deficiency
Active, not recruiting
Agios Pharmaceuticals, Inc.
Phase 2
Study AG348-C-003 is a multicenter study designed to evaluate the safety and efficacy of
different dose levels of AG-348 (mitapivat) in participants with PK deficiency.
Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin
Completed
Agios Pharmaceuticals, Inc.
Phase 1
The purpose of this Phase I, single-dose, open-label trial is to evaluate the
pharmacokinetics, safety, and effect on QTc interval of AG-348 in healthy, adult Japanese and
Non-Asian subjects. The study plans to evaluate 3 cohorts of a single oral dose of AG-348 in
Japanese and Non-Asian subjects. Pharmacokinetic sampling will take place serially at
specified times during conduct of the study.
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