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)

NCT05797701 | Completed Phase 1 FDA Drug

• 2 other identifiers: BDR16957U1111-1256-9220
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis (Healthy Volunteers)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• 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

Study Arms (4)

Treatment A

EXPERIMENTAL

Single dose of SAR443820 tablet in fasted condition

Drug: SAR443820

Treatment B

EXPERIMENTAL

Single dose of SAR443820 capsule in fasted condition

Drug: SAR443820

Treatment C

EXPERIMENTAL

Single dose of SAR443820 tablet in fasted condition

Drug: SAR443820

Treatment D

EXPERIMENTAL

Single dose of SAR443820 tablet in fed condition

Drug: SAR443820

Interventions

SAR443820 DRUG

Tablet by oral administration

Treatment A; Treatment C; Treatment D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Prism Research-Site Number:8400001

Saint Paul, Minnesota, 55144, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 4, 2023
• Study Start: July 28, 2021
• Primary Completion: September 6, 2021
• Study Completion: September 6, 2021
• Last Updated: April 4, 2023

Record last verified: 2023-03-22

Data Sharing

• IPD Sharing: Will share

Locations

US (1)