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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-18

Study Completion Date

2022-07-01

Brief Summary

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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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Detailed Description

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

Conditions

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Amyotrophic Lateral Sclerosis Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part-A, Period-1

Single dose of SAR443820 tablet on Day 1

Group Type EXPERIMENTAL

SAR443820

Intervention Type DRUG

Tablet by oral administration

Part-A, Period-2

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

Group Type EXPERIMENTAL

SAR443820

Intervention Type DRUG

Tablet by oral administration

Erythromycin ethyl succinate

Intervention Type DRUG

Tablet by oral administration

Part-B, Period-1

Single dose of SAR443820 capsule on Day 1

Group Type EXPERIMENTAL

SAR443820

Intervention Type DRUG

Capsule by oral administration

Part-B, Period-2

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

Group Type EXPERIMENTAL

SAR443820

Intervention Type DRUG

Capsule by oral administration

Itraconazole

Intervention Type DRUG

Capsule by oral administration

Interventions

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SAR443820

Tablet by oral administration

Intervention Type DRUG

SAR443820

Capsule by oral administration

Intervention Type DRUG

Erythromycin ethyl succinate

Tablet by oral administration

Intervention Type DRUG

Itraconazole

Capsule by oral administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No