Back to resultsA 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)
Primary Purpose
Amyotrophic Lateral Sclerosis (Healthy Volunteers)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SAR443820
SAR443820
Erythromycin ethyl succinate
Itraconazole
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis (Healthy Volunteers)
Eligibility Criteria
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
Sites / Locations
- Nucleus Network-Site Number:8400001
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Part-A, Period-1
Part-A, Period-2
Part-B, Period-1
Part-B, Period-2
Arm Description
Single dose of SAR443820 tablet on Day 1
Single dose of SAR443820 tablet on Day 6, and erythromycin ethyl succinate (EES) three-time a day (TID) from Day 1 to Day 9
Single dose of SAR443820 capsule on Day 1
Single dose of SAR443820 capsule on Day 6, and Itraconazole once daily (QD) from Day 1 to Day 11
Outcomes
Primary Outcome Measures
Part A: SAR443820: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast)
Part A: SAR443820: Area under the plasma concentration (AUC)
Part B: SAR443820: AUClast
Part B: SAR443820: AUC
Secondary Outcome Measures
Part A: SAR443820: Maximum plasma concentration observed (Cmax)
Part A: SAR443820: Time to reach Cmax (tmax)
Part A: SAR443820: Terminal half-life (t1/2z)
Part B: SAR443820: Cmax
Part B: SAR443820: tmax
Part B: SAR443820: t1/2z
Part A: Erythromycin ethyl succinate concentrations
Part A: Erythromycin base concentration
Part B: Itraconazole: Cmax
Part B: Itraconazole: AUClast
Part B: Hydroxyitraconazole: Cmax
Part B: Hydroxyitraconazole: AUClast
Part A: number of participants with treatment emergent adverse events (TEAEs)
Part B: number of participants with TEAEs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05797753
Brief Title
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)
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 22, 2023
Overall Recruitment Status
Completed
Study Start Date
February 18, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The study duration was approximately 7 weeks for each Part A and Part B.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis (Healthy Volunteers)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part-A, Period-1
Arm Type
Experimental
Arm Description
Single dose of SAR443820 tablet on Day 1
Arm Title
Part-A, Period-2
Arm Type
Experimental
Arm Description
Single dose of SAR443820 tablet on Day 6, and erythromycin ethyl succinate (EES) three-time a day (TID) from Day 1 to Day 9
Arm Title
Part-B, Period-1
Arm Type
Experimental
Arm Description
Single dose of SAR443820 capsule on Day 1
Arm Title
Part-B, Period-2
Arm Type
Experimental
Arm Description
Single dose of SAR443820 capsule on Day 6, and Itraconazole once daily (QD) from Day 1 to Day 11
Intervention Type
Drug
Intervention Name(s)
SAR443820
Intervention Description
Tablet by oral administration
Intervention Type
Drug
Intervention Name(s)
SAR443820
Intervention Description
Capsule by oral administration
Intervention Type
Drug
Intervention Name(s)
Erythromycin ethyl succinate
Intervention Description
Tablet by oral administration
Intervention Type
Drug
Intervention Name(s)
Itraconazole
Intervention Description
Capsule by oral administration
Primary Outcome Measure Information:
Title
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
Title
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
Title
Part B: SAR443820: AUClast
Time Frame
Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12
Title
Part B: SAR443820: AUC
Time Frame
Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12
Secondary Outcome Measure Information:
Title
Part A: SAR443820: Maximum plasma concentration observed (Cmax)
Time Frame
Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10
Title
Part A: SAR443820: Time to reach Cmax (tmax)
Time Frame
Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10
Title
Part A: SAR443820: Terminal half-life (t1/2z)
Time Frame
Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10
Title
Part B: SAR443820: Cmax
Time Frame
Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12
Title
Part B: SAR443820: tmax
Time Frame
Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12
Title
Part B: SAR443820: t1/2z
Time Frame
Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12
Title
Part A: Erythromycin ethyl succinate concentrations
Time Frame
Period 2: Day 6 and Day 7
Title
Part A: Erythromycin base concentration
Time Frame
Period 2: Day 6 and Day 7
Title
Part B: Itraconazole: Cmax
Time Frame
Period 2: Day 6 and Day 7
Title
Part B: Itraconazole: AUClast
Time Frame
Period 2: Day 6 and Day 7
Title
Part B: Hydroxyitraconazole: Cmax
Time Frame
Period 2: Day 6 and Day 7
Title
Part B: Hydroxyitraconazole: AUClast
Time Frame
Period 2: Day 6 and Day 7
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Nucleus Network-Site Number:8400001
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Learn more about this trial
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)
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