CompletedPhase 1

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)

United States18 participantsStarted 2021-07-28

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Po…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: Maximum plasma concentration observed (Cmax)

Timeframe: In both Period 1 and Period 2: From Day 1 to Day 3

Part 2: Maximum plasma concentration observed (Cmax)

Timeframe: 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)

Timeframe: 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)

Timeframe: In both Period 1 and Period 2: From Day 1 to Day 3

Part 1: Area under the plasma concentration (AUC)

Timeframe: In both Period 1 and Period 2: From Day 1 to Day 3

Part 2: Area under the plasma concentration (AUC)

Timeframe: In both Period 1 and Period 2: From Day 1 to Day 3

Trial details

NCT IDNCT05797701

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-06

View on ClinicalTrials.gov More Amyotrophic Lateral Sclerosis (Healthy Volunteers) trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1: Maximum plasma concentration observed (Cmax)

Timeframe: In both Period 1 and Period 2: From Day 1 to Day 3

Part 2: Maximum plasma concentration observed (Cmax)

Timeframe: 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)

Timeframe: 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)

Timeframe: In both Period 1 and Period 2: From Day 1 to Day 3

Part 1: Area under the plasma concentration (AUC)

Timeframe: In both Period 1 and Period 2: From Day 1 to Day 3

Part 2: Area under the plasma concentration (AUC)

Timeframe: In both Period 1 and Period 2: From Day 1 to Day 3