Calendario›AGIO›AG-348

AG-348

A Study to Evaluate the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of AG-348 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348

Ensayo de AGIOS PHARMACEUTICALS, INC. en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

8

previstos

Centros

1

Fin del objetivo primario

jun 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en may 2018.

Qué mide

AG-348 excretado a traves de la orina [A(eu)] (Pre-oral dose and 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study will assess absorption, distribution, metabolism, excretion and absolute bioavailability of AG-348 in healthy male participants. Potential participants will be screened within 29 days prior to dose administration to determine eligibility. Eligible Participants will be admitted into the Clinical Research Unit (CRU) one day prior to administration of AG-348 and will be confined to the CRU until at least Day 8. If participants are not eligible for discharge on Day 8, they may remain in the CRU up to Day 11. Radiolabelled analytes of AG-348 will be administered in a single oral and intravenous (IV) dose on Day 1. Participants will be required to fast pre-dose, remain in a supine position for 1 hour post-dose and avoid water for 2 hours post-dose.

Más ensayos de AGIO

Todos los de AGIO, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03703505), actualizada en oct 2018.