NCT06064539

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Tolebrutinib	Tablet, taken orally
DRUG	gemfibrozil	Tablet, taken orally
DRUG	rifampicin	Tablet, taken orally

Timeline

• Start date: 2020-05-18
• Primary completion: 2020-07-08
• Completion: 2020-07-08
• First posted: 2023-10-03
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study