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

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis (Healthy Volunteers)
• Intervention / Treatment: Drug: SAR443820; Drug: SAR443820

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55144
      • Prism Research-Site Number:8400001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
• Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m^2, inclusive
• All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• Having given written informed consent prior to undertaking any study-related procedure

Exclusion Criteria:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness
• Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any non-live Covid-19 vaccine within the last 2 weeks before randomization, any live attenuated vaccine within the last 28 days before randomization and any other non-vaccine biological drugs given within 4 months before randomization
• Positive result for hepatitis B, C or human immunodeficiency virus (HIV)
• Positive result on urine drug screen
• Positive urine alcohol test
• Positive severe acute respiratory syndrom coronavirus 2 (SARS-CoV-2) test
• Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 5 days before inclusion

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; Single dose of SAR443820 tablet in fasted condition	Drug: SAR443820; Tablet by oral administration; Drug: SAR443820; Capsule by oral administration
Experimental: Treatment B; Single dose of SAR443820 capsule in fasted condition	Drug: SAR443820; Tablet by oral administration; Drug: SAR443820; Capsule by oral administration
Experimental: Treatment C; Single dose of SAR443820 tablet in fasted condition	Drug: SAR443820; Tablet by oral administration; Drug: SAR443820; Capsule by oral administration
Experimental: Treatment D; Single dose of SAR443820 tablet in fed condition	Drug: SAR443820; Tablet by oral administration; Drug: SAR443820; Capsule by oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1: Maximum plasma concentration observed (Cmax)	In both Period 1 and Period 2: From Day 1 to Day 3
Part 2: Maximum plasma concentration observed (Cmax)	In both Period 1 and Period 2: From Day 1 to Day 3
Part 1: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast)	In both Period 1 and Period 2: From Day 1 to Day 3
Part 2: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast)	In both Period 1 and Period 2: From Day 1 to Day 3
Part 1: Area under the plasma concentration (AUC)	In both Period 1 and Period 2: From Day 1 to Day 3
Part 2: Area under the plasma concentration (AUC)	In both Period 1 and Period 2: From Day 1 to Day 3

Secondary Outcome Measures

Outcome Measure	Time Frame
Part 1: Number of participants with treatment emergent adverse events (TEAEs)	In both Period 1 and Period 2: From Day 1 to Day 4
Part 2: Number of participants with treatment emergent adverse events (TEAEs)	In both Period 1 and Period 2: From Day 1 to Day 4

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): September 6, 2021
• Study Completion (Actual): September 6, 2021

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 22, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: BDR16957; U1111-1256-9220 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No