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Completed

NCT Number: NCT05797753

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)

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.

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Healthy Volunteer Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Site Number : 8400001

Saint Paul, Minnesota, 55114, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

SAR443820

Drug

Tablet by oral administration

Erythromycin ethyl succinate

Drug

Tablet by oral administration

Itraconazole

Drug

Capsule by oral administration

Primary outcomes

  1. 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

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

    Time frame: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10

  3. Part B: SAR443820: AUClast

    Time frame: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12

  4. Part B: SAR443820: AUC

    Time frame: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12

Secondary outcomes

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

    Time frame: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10

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

    Time frame: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10

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

    Time frame: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10

  4. Part B: SAR443820: Cmax

    Time frame: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12

  5. Part B: SAR443820: tmax

    Time frame: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12

  6. Part B: SAR443820: t1/2z

    Time frame: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12

  7. Part A: Erythromycin ethyl succinate concentrations

    Time frame: Period 2: Day 6 and Day 7

  8. Part A: Erythromycin base concentration

    Time frame: Period 2: Day 6 and Day 7

  9. Part B: Itraconazole: Cmax

    Time frame: Period 2: Day 6 and Day 7

  10. Part B: Itraconazole: AUClast

    Time frame: Period 2: Day 6 and Day 7

  11. Part B: Hydroxyitraconazole: Cmax

    Time frame: Period 2: Day 6 and Day 7

  12. Part B: Hydroxyitraconazole: AUClast

    Time frame: Period 2: Day 6 and Day 7

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

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2023
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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