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AG-946

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Participants With Sickle Cell Disease

Ensayo de AGIOS PHARMACEUTICALS, INC. en Voluntarios sanos · Anemia de células falciformes.

Fase

Fase 1

Estado

Completado

Participantes

122

previstos

Centros

10

Fin del objetivo primario

dic 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jul 2020.

Qué mide

SAD y MAD: número de participantes que experimentaron al menos un acontecimiento adverso (AE), por gravedad (SAD: Up to Day 13; MAD: Up to Day 49) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of the study is to assess the safety and tolerability of AG-946 in healthy volunteers after oral administration of single ascending doses (SAD) and multiple ascending doses (MAD) of AG-946 over 14 or up to 28 days of dosing, and to identify a range of doses that are safe and pharmacologically active in participants with sickle cell disease. The SAD and MAD parts of the study will be randomized and double-blinded, and will assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of AG-946 as well as the effect of food (SAD only) on the pharmacokinetics (PK) of AG-946. The sickle cell disease (SCD) part of the study will be non-randomized and open-label, and is designed to identify 1 or more safe and tolerable dose(s) of AG-946 with potential activity in the treatment of participants with sickle cell disease (SCD).

Más ensayos de AGIO

Todos los de AGIO, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04536792), actualizada en abr 2024.