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Venglustat

A Study in Adults to Investigate the Impact of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Venglustat Compared to Participants With Normal Hepatic Function

Ensayo de Sanofi en Hepatic Function Abnormal (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

26

previstos

Centros

6

Fin del objetivo primario

ene 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en ene 2023.

Qué mide

Maximum venglustat plasma concentration observed (Cmax) (del registro, en inglés) (del inicio al dia 20)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a parallel, Phase 1, four arm, open-label, single dose, multicenter study to evaluate the impact of hepatic impairment on venglustat exposure following treatment with venglustat. The purpose of this study is to assess the effect of mild, moderate, and severe hepatic impairment on PK, safety, and tolerability of venglustat compared with normal hepatic function in male and female participants aged 18 to 79 years. Study details include: * The total study duration per participant will be up to 42 days, including up to 21 days for screening and approximately 21 days from institutionalization to the end of study (EOS). * Institutionalization is mandatory until the activities on D5 have been completed. * Each participant will receive a single dose of venglustat. * For hepatically impaired participants there will be a screening visit, a multi-day institutionalization visit, and 7 site visits after D5 discharge, including the end of study (EOS) visit. * For healthy volunteers there will be a screening visit, a multi-day institutionalization visit and 3 site visits after D5 discharge, including the end of study (EOS) visit.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05718258), actualizada en sep 2025.