Back to resultsA 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)
Primary Purpose
Amyotrophic Lateral Sclerosis (Healthy Volunteers)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SAR443820
SAR443820
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis (Healthy Volunteers)
Eligibility Criteria
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.
Sites / Locations
- Prism Research-Site Number:8400001
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Treatment A
Treatment B
Treatment C
Treatment D
Arm Description
Single dose of SAR443820 tablet in fasted condition
Single dose of SAR443820 capsule in fasted condition
Single dose of SAR443820 tablet in fasted condition
Single dose of SAR443820 tablet in fed condition
Outcomes
Primary Outcome Measures
Part 1: Maximum plasma concentration observed (Cmax)
Part 2: Maximum plasma concentration observed (Cmax)
Part 1: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast)
Part 2: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast)
Part 1: Area under the plasma concentration (AUC)
Part 2: Area under the plasma concentration (AUC)
Secondary Outcome Measures
Part 1: Number of participants with treatment emergent adverse events (TEAEs)
Part 2: Number of participants with treatment emergent adverse events (TEAEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05797701
Brief Title
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)
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 22, 2023
Overall Recruitment Status
Completed
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
September 6, 2021 (Actual)
Study Completion Date
September 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis (Healthy Volunteers)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Description
Single dose of SAR443820 tablet in fasted condition
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
Single dose of SAR443820 capsule in fasted condition
Arm Title
Treatment C
Arm Type
Experimental
Arm Description
Single dose of SAR443820 tablet in fasted condition
Arm Title
Treatment D
Arm Type
Experimental
Arm Description
Single dose of SAR443820 tablet in fed condition
Intervention Type
Drug
Intervention Name(s)
SAR443820
Intervention Description
Tablet by oral administration
Intervention Type
Drug
Intervention Name(s)
SAR443820
Intervention Description
Capsule by oral administration
Primary Outcome Measure Information:
Title
Part 1: Maximum plasma concentration observed (Cmax)
Time Frame
In both Period 1 and Period 2: From Day 1 to Day 3
Title
Part 2: Maximum plasma concentration observed (Cmax)
Time Frame
In both Period 1 and Period 2: From Day 1 to Day 3
Title
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
Title
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
Title
Part 1: Area under the plasma concentration (AUC)
Time Frame
In both Period 1 and Period 2: From Day 1 to Day 3
Title
Part 2: Area under the plasma concentration (AUC)
Time Frame
In both Period 1 and Period 2: From Day 1 to Day 3
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Prism Research-Site Number:8400001
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55144
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
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)
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