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entinostat

A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects

Ensayo de Syndax Pharmaceuticals Inc en Volunteers · Healthy Volunteers · Human Volunteers · Normal Volunteers (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

66

previstos

Centros

2

Fin del objetivo primario

abr 2017

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en oct 2016.

Qué mide

AUC0-t (area under the concentration-time curve) for entinostat administered with or without omeprazole (Part 1), with or without famotidine (Part 2), or omeprazole with and without acidic beverage (Pre-dose through Day 22) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this study is therefore to evaluate the effect of concomitant drugs through an increase of intra-gastric pH levels on the bioavailability of entinostat. The primary objectives of this study are to evaluate the effect of multiple doses of omeprazole, famotidine, and the effect of an acidic beverage in combination with omeprazole on the single-dose PK profile of entinostat. The secondary objectives are to evaluate the safety and tolerability of a single dose of entinostat when administered with multiple doses of omeprazole, famotidine, and when administered with an acidic beverage in combination with omeprazole.

Más ensayos de SNDX

Todos los de SNDX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02922933), actualizada en ago 2018.