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SAR443820

A Study in Healthy Adult Male & Female Participants to Assess the Amount of the Study Medicine (SAR443820) Absorbed by the Body, When Given Orally in Fasted Condition as a Tablet Versus as a Capsule (Part 1) and When Given Orally as a Tablet in Fasted Condition Versus as a Tablet After Food (Part 2)

Ensayo de Sanofi en Amyotrophic Lateral Sclerosis (Healthy Volunteers) (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

18

previstos

Centros

1

Fin del objetivo primario

sep 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jul 2021.

Qué mide

Part 1: Maximum plasma concentration observed (Cmax) (In both Period 1 and Period 2: From Day 1 to Day 3) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPart 1: This is an open label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment A and Treatment B for Part 1), study part to determine the relative bioavailability of SAR443820 in tablet formulation versus capsule formulation under fasted conditions. Two treatments are as follows: * Treatment A: SAR443820 - tablet formulation in fasted condition * Treatment B: SAR443820 - capsule formulation in fasted condition Each administration will be a single dose of SAR443820 separated by a wash out of at least 5 days. Part 2: This is an open-label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment C and Treatment D for Part 2) study part to perform a preliminary assessment of the effect of a high-fat meal on pharmacokinetic parameters of single dose of SAR443820 in tablet formulation. Two treatments are as follows: * Treatment C: SAR443820 - tablet formulation in fasted condition * Treatment D: SAR443820 - tablet formulation in fed condition Each administration will be a single dose of SAR443820 separated by a wash out of at least 5 days. Participants are not allowed to participate in more than one part of the study. In both Parts 1 and 2, the assessment of pharmacokinetic, safety and tolerability are performed at each treatment period at baseline (prior single dosing) up to 48-hour postdosing in healthy adult male and female participants.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05797701), actualizada en mar 2023.