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AG-519

A Safety and Tolerability Study of AG-519 in Healthy Subjects

Ensayo de AGIOS PHARMACEUTICALS, INC. en Anemia.

Más ensayos de: Anemia.

Fase

Fase 1

Estado

Interrumpido

Participantes

108

previstos

Centros

1

Fin del objetivo primario

dic 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en dic 2015.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Agios is no longer developing its second pyruvate kinase-R (PKR) activator, AG-519, and withdrew its investigational new drug (IND) application in December 2016».

Qué mide

Incidencia de acontecimientos adversos surgidos del tratamiento (14 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of the study is to investigate a drug called AG-519, which is being developed for the treatment of a disease called pyruvate kinase deficiency (also known as PK deficiency) and other forms of anemia. This study is a 5 part study with Part 1 enrolling healthy volunteers into single ascending dose (SAD) groups, Part 2 enrolling healthy volunteers into multiple ascending dose (MAD) groups and Part 3 enrolling healthy volunteers to investigate how much of the study drug is taken up by the body and how food affects the uptake of a prototype formulation of AG-519, Part 4 enrolling healthy volunteers of Japanese origin to compare to the results of subjects of non-Japanese origin, and Part 5 a non-randomized, open-label, multiple dose study enrolling healthy volunteers to further investigate how much of the study drug is taken up by the body when dosed over 14 days.

Más ensayos de AGIO

Todos los de AGIO, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02630927), actualizada en jun 2017.