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)

NCT05797753 | Completed Phase 1 FDA Drug

• 2 other identifiers: INT17470U1111-1267-9023
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Amyotrophic Lateral Sclerosis; Healthy Volunteer

Outcome Measures

Primary Outcomes (4)

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

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

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

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

• Part B: SAR443820: AUClast

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

• Part B: SAR443820: AUC

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

Secondary Outcomes (14)

• Part A: SAR443820: Maximum plasma concentration observed (Cmax)

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

• Part A: SAR443820: Time to reach Cmax (tmax)

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

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

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

• Part B: SAR443820: Cmax

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

• Part B: SAR443820: tmax

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

Study Arms (4)

Part-A, Period-1

EXPERIMENTAL

Single dose of SAR443820 tablet on Day 1

Drug: SAR443820

Part-A, Period-2

EXPERIMENTAL

Single dose of SAR443820 tablet on Day 6, and erythromycin ethyl succinate (EES) three-time a day (TID) from Day 1 to Day 9

Drug: SAR443820; Drug: Erythromycin ethyl succinate

Part-B, Period-1

EXPERIMENTAL

Single dose of SAR443820 capsule on Day 1

Drug: SAR443820

Part-B, Period-2

EXPERIMENTAL

Single dose of SAR443820 capsule on Day 6, and Itraconazole once daily (QD) from Day 1 to Day 11

Drug: SAR443820; Drug: Itraconazole

Interventions

SAR443820 DRUG

Tablet by oral administration

Part-A, Period-1; Part-A, Period-2

Erythromycin ethyl succinate DRUG

Tablet by oral administration

Part-A, Period-2

Itraconazole DRUG

Capsule by oral administration

Part-B, Period-2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Nucleus Network Site Number : 8400001

Saint Paul, Minnesota, 55114, United States

Location

Related Links

• INT17470 Plain language Results Summary

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Erythromycin; Itraconazole

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 4, 2023
• Study Start: February 18, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)