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Amyotrophic Lateral SclerosisPhase 1NCT05797753

A Study to Assess the Effect of Erythromycin on the Test Medicine (SAR443820) When Given Orally as Tablets to Healthy Adult Male and Female Participants (Part A); and the Effect of Itraconazole on the Test Medicine (SAR443820) When Given Orally as Capsules to Healthy Adult Male Participants (Part B)

A Phase 1 study testing SAR443820, Erythromycin ethyl succinate and Itraconazole in people with Amyotrophic Lateral Sclerosis and Healthy Volunteer, run by Sanofi at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1, cross-over, 2-part study for pharmacokinetic (PK) assessment of SAR443820 when co-administered with cytochrome P450 3A4 (CYP3A4) inhibitors (erythromycin ethyl succinate (EES) in Part A and possibly itraconazole in Part B). Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
SAR443820, Erythromycin ethyl succinate and Itraconazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
18 Feb 2022to 1 Jul 2022
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
  • No healthy volunteers
  • Adult

Who may be able to join

  • Part A: male or female participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent
  • Part B: male participant only must be 18 to 55 years of age inclusive, at the time of signing the informed consent
  • 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
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Who cannot join

  • Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), 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 inclusion, any live attenuated vaccine within the last 28 days before inclusion and any other non-vaccine biological drugs given within 4 months before inclusion
  • Current enrollment in Part A (applicable for Part B) or past participation in previous clinical study on SAR443820
  • Positive result for hepatitis B, C or human immunodeficiency virus (HIV)
  • Positive result on urine drug screen
  • Positive urine alcohol 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

  • Nucleus Network Site Number : 8400001

    Saint Paul, Minnesota, 55114

Other trials in United States

About this study

Official title: A Phase 1, Single-center, Open-label, 2-part, 2-treatment Period, 1-sequence, Cross-over, Drug-drug Interaction Study to Investigate the Effect of Erythromycin on SAR443820 (Part A) and the Effect of Itraconazole on SAR443820 (Part B) in Healthy Adult Participants

This is a Phase 1, cross-over, 2-part study for pharmacokinetic (PK) assessment of SAR443820 when co-administered with cytochrome P450 3A4 (CYP3A4) inhibitors (erythromycin ethyl succinate (EES) in Part A and possibly itraconazole in Part B).

In Part A, the objective is to assess the effects of repeated administration of EES as CYP3A4 inhibitor, on the PK profile of a single oral dose of SAR443820 tablet in healthy male and female participants.

Read more

In Part B, the objective is to assess the effects of repeated administration of itraconazole on the PK profile of a single oral dose of SAR443820 capsule in healthy male participants.

Part A includes a screening period, Period 1 (SAR443820), a wash-out period and Period 2 (SAR443820 + EES). Part B includes a screening period, Period 1 (SAR443820), a wash-out period and Period 2 (SAR443820 + itraconazole). The washout period between single SAR443820 administration in Period 1 and the start of dosing with EES (Part A) or itraconazole (Part B) in Period 2 is at least 4 days.

The study duration is approximately 7 weeks for each Part A and Part B.

The treatment duration is:

  • For SAR443820 (both Part A and Part B): 1 day in each Period; single dose of SAR443830 on Period 1 (P1)-Day 1 and on Period 2 (P2)-Day 6 for each Part.
  • For EES (Part A): 9 days of treatment in Period 2 with P2-Day 1 starting at least 4 days after P1-Day 1.
  • For itraconazole (Part B): the treatment duration lasts 11 days in Period 2 and it is fixed once the results of Part A are issued, P2-Day 1 starting at least 4 days after P1-Day 1.
Read the detailed description

The study duration was approximately 7 weeks for each Part A and Part B.

Being tested
SAR443820, Erythromycin ethyl succinate, Itraconazole
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

  • Erythromycin ethyl succinateDrug

    Tablet by oral administration

  • ItraconazoleDrug

    Capsule by oral administration

Study groups in NCT05797753
Study groupRoleWhat they receive
Part-A, Period-1ExperimentalSingle dose of SAR443820 tablet on Day 1
Receives: Drug: SAR443820
Part-A, Period-2ExperimentalSingle dose of SAR443820 tablet on Day 6, and erythromycin ethyl succinate (EES) three-time a day (TID) from Day 1 to Day 9
Receives: Drug: SAR443820; Drug: Erythromycin ethyl succinate
Part-B, Period-1ExperimentalSingle dose of SAR443820 capsule on Day 1
Receives: Drug: SAR443820
Part-B, Period-2ExperimentalSingle dose of SAR443820 capsule on Day 6, and Itraconazole once daily (QD) from Day 1 to Day 11
Receives: Drug: SAR443820; Drug: Itraconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: SAR443820: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast)

    Measured: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10

  2. Part A: SAR443820: Area under the plasma concentration (AUC)

    Measured: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10

  3. Part B: SAR443820: AUClast

    Measured: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12

  4. Part B: SAR443820: AUC

    Measured: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12

Secondary outcomes (14)

  1. Part A: SAR443820: Maximum plasma concentration observed (Cmax)

    Measured: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10

  2. Part A: SAR443820: Time to reach Cmax (tmax)

    Measured: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10

  3. Part A: SAR443820: Terminal half-life (t1/2z)

    Measured: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10

  4. Part B: SAR443820: Cmax

    Measured: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12

  5. Part B: SAR443820: tmax

    Measured: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12

  6. Part B: SAR443820: t1/2z

    Measured: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12

  7. Part A: Erythromycin ethyl succinate concentrations

    Measured: Period 2: Day 6 and Day 7

  8. Part A: Erythromycin base concentration

    Measured: Period 2: Day 6 and Day 7

  9. Part B: Itraconazole: Cmax

    Measured: Period 2: Day 6 and Day 7

  10. Part B: Itraconazole: AUClast

    Measured: Period 2: Day 6 and Day 7

  11. Part B: Hydroxyitraconazole: Cmax

    Measured: Period 2: Day 6 and Day 7

  12. Part B: Hydroxyitraconazole: AUClast

    Measured: Period 2: Day 6 and Day 7

  13. Part A: number of participants with treatment emergent adverse events (TEAEs)

    Measured: Period 1: Day 1 to Day 4; Period 2: Day 1 to Day 10 + 3 days of end of study (EOS) period

  14. Part B: number of participants with TEAEs

    Measured: Period 1: Day 1 to Day 4; Period 2: Day 1 to Day 12 + 8-10 days of end of study (EOS) period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start18 Feb 2022
  3. Primary completion1 Jul 2022
  4. Study completion1 Jul 2022

Resources

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
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05797753
Sponsor's protocol ID
INT17470
Other IDs
U1111-1267-9023, INT17470
Status last verified
Jan 2025
First submitted
22 Mar 2023
Last updated
3 Jan 2025
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAR443820, Erythromycin ethyl succinate and Itraconazole in people with Amyotrophic Lateral Sclerosis and Healthy Volunteer, 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 4 inclusion and 6 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 3 Jan 2025. 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 A: SAR443820: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast) (time frame: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05797753.

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 3 Jan 2025.

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