Study Purpose:
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 Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis (Healthy Volunteers)
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
SAR443820
Placebo:
Yes
Phase:
Phase 1
Study Chair(s)/Principal Investigator(s):
Clinical Sciences & Operations, Sanofi
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Full Study Summary:
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 Sponsor:
Sanofi
Estimated Enrollment:
18
Estimated Study Start Date:
07 / 28 / 2021
Estimated Study Completion Date:
09 / 06 / 2021
Posting Last Modified Date:
04 / 04 / 2023
Date Study Added to neals.org:
04 / 04 / 2023
Accepts healthy volunteers:
Yes
Minimum Age:
18 Years
Maximum Age:
55 Years
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.
Prism Research-Site Number:8400001
Saint Paul, Minnesota
55144
United States