Amyotrophic Lateral Sclerosis (Healthy Volunteers)Phase 1NCT05797701
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)
A Phase 1 study testing SAR443820 in people with Amyotrophic Lateral Sclerosis (Healthy Volunteers), run by Sanofi at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (Healthy Volunteers)
- What is being tested?
- SAR443820
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2021to 6 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Prism Research-Site Number:8400001
Saint Paul, Minnesota, 55144
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- SAR443820
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR443820Drug
Tablet by oral administration
SAR443820Drug
Capsule by oral administration
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Single dose of SAR443820 tablet in fasted condition Receives: Drug: SAR443820 |
| Treatment B | Experimental | Single dose of SAR443820 capsule in fasted condition Receives: Drug: SAR443820 |
| Treatment C | Experimental | Single dose of SAR443820 tablet in fasted condition Receives: Drug: SAR443820 |
| Treatment D | Experimental | Single dose of SAR443820 tablet in fed condition Receives: Drug: SAR443820 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Maximum plasma concentration observed (Cmax)
Measured: In both Period 1 and Period 2: From Day 1 to Day 3
Part 2: Maximum plasma concentration observed (Cmax)
Measured: 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)
Measured: 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)
Measured: In both Period 1 and Period 2: From Day 1 to Day 3
Part 1: Area under the plasma concentration (AUC)
Measured: In both Period 1 and Period 2: From Day 1 to Day 3
Part 2: Area under the plasma concentration (AUC)
Measured: In both Period 1 and Period 2: From Day 1 to Day 3
Secondary outcomes (2)
Part 1: Number of participants with treatment emergent adverse events (TEAEs)
Measured: In both Period 1 and Period 2: From Day 1 to Day 4
Part 2: Number of participants with treatment emergent adverse events (TEAEs)
Measured: In both Period 1 and Period 2: From Day 1 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start28 Jul 2021
- Primary completion6 Sep 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (Healthy Volunteers)Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797701
- Sponsor's protocol ID
- BDR16957
- Other IDs
- U1111-1256-9220
- Status last verified
- 22 Mar 2023
- First submitted
- 22 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05797701
- Acronym / sponsor ID
- BDR16957
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: SAR443820Single dose of SAR443820 tablet in fasted condition |
| Treatment B | Experimental | Drug: SAR443820Single dose of SAR443820 capsule in fasted condition |
| Treatment C | Experimental | Drug: SAR443820Single dose of SAR443820 tablet in fasted condition |
| Treatment D | Experimental | Drug: SAR443820Single dose of SAR443820 tablet in fed condition |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR443820Tablet by oral administration | Drug | Treatment A, Treatment C, Treatment D |
| SAR443820Capsule by oral administration | Drug | Treatment B |
Primary outcome
Part 1: Maximum plasma concentration observed (Cmax)
Time frame: In both Period 1 and Period 2: From Day 1 to Day 3
Part 2: Maximum plasma concentration observed (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: In both Period 1 and Period 2: From Day 1 to Day 3
Part 1: Area under the plasma concentration (AUC)
Time frame: In both Period 1 and Period 2: From Day 1 to Day 3
Part 2: Area under the plasma concentration (AUC)
Time frame: In both Period 1 and Period 2: From Day 1 to Day 3
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: Yes. 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR443820 in people with Amyotrophic Lateral Sclerosis (Healthy Volunteers), run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Maximum plasma concentration observed (Cmax) (time frame: In both Period 1 and Period 2: From Day 1 to Day 3). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.