NCT05797701

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)

An Open-label, Randomized, 2-sequence, 2-period, 2-treatment, 2-part Study to Evaluate the Relative Bioavailability of SAR443820 in Tablet Formulation Versus Capsule Formulation in Fasted Condition (Part 1) and the Food-effect on SAR443820 in Tablet Formulation (Part 2) in Healthy Adult Male and Female Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Part 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.

Detailed description

Screening period: up to 4 weeks (Day -28 to Day -2). In both Part 1 and Part 2: Period 1: Day -1 to Day 3 and 5 days wash out period. Period 2: Day -1 to Day 3 and until end-of-study visit at Day 6.

Conditions

• Amyotrophic Lateral Sclerosis (Healthy Volunteers)

Interventions

Type	Name	Description
DRUG	SAR443820	Tablet by oral administration
DRUG	SAR443820	Capsule by oral administration

Timeline

• Start date: 2021-07-28
• Primary completion: 2021-09-06
• Completion: 2021-09-06
• First posted: 2023-04-04
• Last updated: 2023-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study