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Diroximel fumarate

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants

Ensayo de BIOGEN INC. en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

32

previstos

Centros

2

Fin del objetivo primario

jun 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en dic 2021.

Qué mide

Maximum Observed Concentration (Cmax) of Monomethyl Fumarate (MMF) (Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective is to evaluate the primary pharmacokinetic (PK) parameters of DRF active metabolite monomethyl fumarate (MMF) following multiple doses of DRF in Chinese and Caucasian adult healthy participants. The secondary objectives are to evaluate the secondary PK parameters of DRF active metabolite MMF following multiple doses of DRF in Chinese and Caucasian adult healthy participants, to evaluate the PK of DRF inactive major metabolite 2-hydroxyethyl succinimide (HES) following multiple doses of DRF in Chinese and Caucasian adult healthy participants and to evaluate the safety and tolerability of multiple oral doses of DRF in Chinese and Caucasian adult healthy participants.

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05127564), actualizada en jul 2022.