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Rilzabrutinib crystalline form

A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

Ensayo de Sanofi en Autoimmune Disorder · Healthy Volunteers (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

28

previstos

Centros

1

Fin del objetivo primario

abr 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en mar 2024.

Qué mide

Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fasted state (del registro, en inglés) (del dia 1 al dia 8)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age. The total study duration per participant is expected to be up to 36 days, including: * Screening: up to 4 weeks * Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods. * Washout: One day washout is planned after each treatment period hence providing 2 days between doses. * Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06342700), actualizada en ago 2025.