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 range18 Years – 55 Years

SexALL

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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…

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 range18 Years – 55 Years

SexALL

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