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

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-18

Study Completion Date

2020-07-08

Brief Summary

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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.

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Detailed Description

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Study duration per participant approximately 16 days for Cohort 1 and approximately 18 days for Cohort 2.

Conditions

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Multiple Sclerosis

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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Cohort 1

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

Group Type EXPERIMENTAL

Tolebrutinib

Intervention Type DRUG

Tablet, taken orally

gemfibrozil

Intervention Type DRUG

Tablet, taken orally

Cohort 2

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

Group Type EXPERIMENTAL

Tolebrutinib

Intervention Type DRUG

Tablet, taken orally

rifampicin

Intervention Type DRUG

Tablet, taken orally

Interventions

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Tolebrutinib

Tablet, taken orally

Intervention Type DRUG

gemfibrozil

Tablet, taken orally

Intervention Type DRUG

rifampicin

Tablet, taken orally

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes