CLINICAL TRIALS PROFILE FOR AG-348
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Clinical Trials for AG-348
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT02108106 ↗ | A Phase I Study of AG-348 in Healthy Volunteers | Completed | Agios Pharmaceuticals, Inc. | Phase 1 | 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. |
| NCT02149966 ↗ | A Phase I Study of AG-348 in Healthy Volunteers | Completed | Agios Pharmaceuticals, Inc. | Phase 1 | 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. |
| NCT02476916 ↗ | 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. |
| NCT03250598 ↗ | 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. |
| NCT03397329 ↗ | Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults | Completed | Agios Pharmaceuticals, Inc. | Phase 1 | The purpose of this Phase 1, randomized, open-label, two-period crossover study is to characterize and compare the pharmacokinetic (PK) profiles and evaluate the safety of the AG-348 tablet and capsule formulations after single-dose administration in healthy adult subjects. Pharmacokinetic sampling will take place serially at specified times during conduct of the study. |
| NCT03548220 ↗ | A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD) | Completed | Agios Pharmaceuticals, Inc. | Phase 3 | Study AG348-C-006 will evaluate the efficacy and safety of orally administered AG-348 as compared with placebo in participants with pyruvate kinase deficiency (PKD), who are not regularly receiving blood transfusions. Participants will be randomized 1:1 to receive either AG-348 or matching placebo. The study is comprised of two parts. During the Part 1 Dose Optimization Period of the study, participants will start on a dose of 5 mg AG-348 administered twice daily. Over the course of Part 1, each participant's dose of AG-348 may be sequentially increased to 20 mg twice a day, followed by 50 mg twice a day depending on their tolerance. During the Part 2 Fixed-Dose Period, participants will receive AG-348 at their optimized dose from Part 1. |
| NCT03559699 ↗ | A Study Evaluating the Efficacy and Safety of AG-348 in Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD) | Completed | Agios Pharmaceuticals, Inc. | Phase 3 | Study AG348-C-007 is a multicenter study designed to evaluate the efficacy and safety of treatment with AG-348 in a minimum of 20, with up to 40, subjects with pyruvate kinase deficiency (PKD), who are regularly receiving blood transfusions. The study is comprised of two parts. During the Part 1 Dose Optimization Period of the study, all participants will start on a dose of 5 mg AG-348 administered twice daily. Over the course of Part 1 each participant's dose will be optimized individually, up to a maximum dose of 50 milligrams (mg), twice daily. During the Part 2 Fixed-Dose Period, participants will receive AG-348 at their optimized dose from Part 1. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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