search
Back to results

Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tolebrutinib
gemfibrozil
rifampicin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Male participant, between 18 and 45 years of age, inclusive. Body weight between 50.0 and 100.0 kg, inclusive, body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. Having given written informed consent prior to undertaking any study-related procedure. Exclusion Criteria: Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Participants with known hypersensitivity to any component of the IMP formulation or allergic disease diagnosed and treated by a physician. Any medication (including St John's Wort and ginseng) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Any contraindications to gemfibrozil or rifampicin, according to the applicable labelling. Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Prism Research-Site Number:8400001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

SAR442168 administered alone and together with gemfibrozil. 1 day washout for each administration of SAR442168.

SAR442168 administered alone and together with rifampicin. 1 day washout for each administration of SAR442168.

Outcomes

Primary Outcome Measures

Pharmacokinetics: AUClast of SAR442168
AUC up to the last measurable concentration
Pharmacokinetics: AUC of SAR442168
Area under the curve, reflects the concentration of drug

Secondary Outcome Measures

Pharmacokinetics: Maximum plasma concentration observed (Cmax) of SAR442168
Pharmacokinetics: Cmax of SAR442168 metabolite(s)
Pharmacokinetics: AUC of SAR442168 metabolite(s)
Pharmacokinetics: Time to reach Cmax (tmax) of SAR442168
Pharmacokinetics: tmax of SAR442168 metabolite(s)
Pharmacokinetics: Cmax of gemfibrozil
Pharmacokinetics: Cmax of gemfibrozil 1-O-glucuronide
Pharmacokinetics: tmax of gemfibrozil
Pharmacokinetics: tmax of gemfibrozil 1-O-glucuronide
Pharmacokinetics: Cmax of rifampicin
Pharmacokinetics: tmax of rifampicin
Numbers of participants with adverse events (AEs)

Full Information

First Posted
September 26, 2023
Last Updated
September 26, 2023
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT06064539
Brief Title
Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects
Official Title
A Phase 1, Single-center, Open-label, Two-cohort, Two-period, One-sequence, Two Treatment, Drug-drug Interaction Study of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 22, 2023
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
July 8, 2020 (Actual)
Study Completion Date
July 8, 2020 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 1, single-center, open-label, non-randomized study to assess the effects of CYP2C8 inhibition using gemfibrozil, and CYP3A4 and CYP2C8 induction using rifampicin on the pharmacokinetics of SAR442168 in healthy male participants aged 18 to 45 years.
Detailed Description
Study duration per participant approximately 16 days for Cohort 1 and approximately 18 days for Cohort 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
SAR442168 administered alone and together with gemfibrozil. 1 day washout for each administration of SAR442168.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
SAR442168 administered alone and together with rifampicin. 1 day washout for each administration of SAR442168.
Intervention Type
Drug
Intervention Name(s)
Tolebrutinib
Intervention Description
Tablet, taken orally
Intervention Type
Drug
Intervention Name(s)
gemfibrozil
Intervention Description
Tablet, taken orally
Intervention Type
Drug
Intervention Name(s)
rifampicin
Intervention Description
Tablet, taken orally
Primary Outcome Measure Information:
Title
Pharmacokinetics: AUClast of SAR442168
Description
AUC up to the last measurable concentration
Time Frame
Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Title
Pharmacokinetics: AUC of SAR442168
Description
Area under the curve, reflects the concentration of drug
Time Frame
Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Maximum plasma concentration observed (Cmax) of SAR442168
Time Frame
Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Title
Pharmacokinetics: Cmax of SAR442168 metabolite(s)
Time Frame
Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Title
Pharmacokinetics: AUC of SAR442168 metabolite(s)
Time Frame
Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Title
Pharmacokinetics: Time to reach Cmax (tmax) of SAR442168
Time Frame
Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Title
Pharmacokinetics: tmax of SAR442168 metabolite(s)
Time Frame
Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Title
Pharmacokinetics: Cmax of gemfibrozil
Time Frame
From Day 1 to Day 7 of Period 2
Title
Pharmacokinetics: Cmax of gemfibrozil 1-O-glucuronide
Time Frame
From Day 1 to Day 7 of Period 2
Title
Pharmacokinetics: tmax of gemfibrozil
Time Frame
From Day 1 to Day 7 of Period 2
Title
Pharmacokinetics: tmax of gemfibrozil 1-O-glucuronide
Time Frame
From Day 1 to Day 7 of Period 2
Title
Pharmacokinetics: Cmax of rifampicin
Time Frame
From Day 1 to Day 9 of Period 2
Title
Pharmacokinetics: tmax of rifampicin
Time Frame
From Day 1 to Day 9 of Period 2
Title
Numbers of participants with adverse events (AEs)
Time Frame
From baseline to End of Study (i.e. Period 2 Day 16 days in Cohort 1, and Period 2 Day18 days in Cohort 2)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male participant, between 18 and 45 years of age, inclusive. Body weight between 50.0 and 100.0 kg, inclusive, body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. Having given written informed consent prior to undertaking any study-related procedure. Exclusion Criteria: Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Participants with known hypersensitivity to any component of the IMP formulation or allergic disease diagnosed and treated by a physician. Any medication (including St John's Wort and ginseng) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Any contraindications to gemfibrozil or rifampicin, according to the applicable labelling. Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. The above information is not intended to contain all considerations relevant to a patient's 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
Prism Research-Site Number:8400001
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55144
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

Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects

We'll reach out to this number within 24 hrs