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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis

Treatments: Drug: Tolebrutinib; Drug: rifampicin; Drug: gemfibrozil

Study type: Interventional

Funder types: Industry

Identifiers

NCT06064539

INT16726

U1111-1244-2759 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: gemfibrozil

Drug: Tolebrutinib

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: rifampicin

Drug: Tolebrutinib