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SAR443820

A Study to Assess the Effect of Erythromycin on the Test Medicine (SAR443820) When Given Orally as Tablets to Healthy Adult Male and Female Participants (Part A); and the Effect of Itraconazole on the Test Medicine (SAR443820) When Given Orally as Capsules to Healthy Adult Male Participants (Part B)

Ensayo de Sanofi en Esclerosis lateral amiotrofica · Voluntarios sanos.

Más ensayos de: Esclerosis lateral amiotrófica.

Fase

Fase 1

Estado

Completado

Participantes

16

previstos

Centros

1

Fin del objetivo primario

jul 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en feb 2022.

Qué mide

Part A: SAR443820: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast) (Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a Phase 1, cross-over, 2-part study for pharmacokinetic (PK) assessment of SAR443820 when co-administered with cytochrome P450 3A4 (CYP3A4) inhibitors (erythromycin ethyl succinate (EES) in Part A and possibly itraconazole in Part B). In Part A, the objective is to assess the effects of repeated administration of EES as CYP3A4 inhibitor, on the PK profile of a single oral dose of SAR443820 tablet in healthy male and female participants. In Part B, the objective is to assess the effects of repeated administration of itraconazole on the PK profile of a single oral dose of SAR443820 capsule in healthy male participants. Part A includes a screening period, Period 1 (SAR443820), a wash-out period and Period 2 (SAR443820 + EES). Part B includes a screening period, Period 1 (SAR443820), a wash-out period and Period 2 (SAR443820 + itraconazole). The washout period between single SAR443820 administration in Period 1 and the start of dosing with EES (Part A) or itraconazole (Part B) in Period 2 is at least 4 days. The study duration is approximately 7 weeks for each Part A and Part B. The treatment duration is: * For SAR443820 (both Part A and Part B): 1 day in each Period; single dose of SAR443830 on Period 1 (P1)-Day 1 and on Period 2 (P2)-Day 6 for each Part. * For EES (Part A): 9 days of treatment in Period 2 with P2-Day 1 starting at least 4 days after P1-Day 1. * For itraconazole (Part B): the treatment duration lasts 11 days in Period 2 and it is fixed once the results of Part A are issued, P2-Day 1 starting at least 4 days after P1-Day 1.

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05797753), actualizada en ene 2025.