A Phase I Study of AG-348 in Healthy Volunteers

Phase 1 Completed 48 enrolled Agios Pharmaceuticals, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start: 2014-03
Primary completion: 2014-08
Completion: 2014-08

Publications

Yang H, Merica E, Chen Y, Cohen M, Goldwater R, Kosinski PA, Kung C, Yuan ZJ, Silverman L, Goldwasser M, Silver BA, Agresta S, Barbier AJ. Phase 1 Single- and Multiple-Ascending-Dose Randomized Studies of the Safety, Pharmacokinetics, and Pharmacodynamics of AG-348, a First-in-Class Allosteric Activator of Pyruvate Kinase R, in Healthy Volunteers. Clin Pharmacol Drug Dev. 2019 Feb;8(2):246-259. doi: 10.1002/cpdd.604. Epub 2018 Aug 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mitapivat	Small molecule	—	Oral

Indications

No indication recorded.