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Completed

NCT Number: 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)

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis (Healthy Volunteers) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Prism Research-Site Number:8400001

Saint Paul, Minnesota, 55144, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR443820

Drug

Tablet by oral administration

Primary outcomes

  1. Part 1: Maximum plasma concentration observed (Cmax)

    Time frame: In both Period 1 and Period 2: From Day 1 to Day 3

  2. Part 2: Maximum plasma concentration observed (Cmax)

    Time frame: In both Period 1 and Period 2: From Day 1 to Day 3

  3. Part 1: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast)

    Time frame: In both Period 1 and Period 2: From Day 1 to Day 3

  4. Part 2: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast)

    Time frame: In both Period 1 and Period 2: From Day 1 to Day 3

  5. Part 1: Area under the plasma concentration (AUC)

    Time frame: In both Period 1 and Period 2: From Day 1 to Day 3

  6. Part 2: Area under the plasma concentration (AUC)

    Time frame: In both Period 1 and Period 2: From Day 1 to Day 3

Secondary outcomes

  1. Part 1: Number of participants with treatment emergent adverse events (TEAEs)

    Time frame: In both Period 1 and Period 2: From Day 1 to Day 4

  2. Part 2: Number of participants with treatment emergent adverse events (TEAEs)

    Time frame: In both Period 1 and Period 2: From Day 1 to Day 4

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 4, 2023
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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