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

Part of paid clinical trials in Saint Paul, Minnesota.

Sponsor
Sanofi
Study ID
NCT06064539
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Tolebrutinib — DRUG
    Tablet, taken orally
  • gemfibrozil — DRUG
    Tablet, taken orally
  • rifampicin — DRUG
    Tablet, taken orally

Study Details

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.

Key Dates

Start date
May 18, 2020
Status verified
Sep 2025
Primary completion
Jul 8, 2020
Completion
Jul 8, 2020

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    SAR442168 administered alone and together with gemfibrozil. 1 day washout for each administration of SAR442168.
  • Experimental: Cohort 2
    SAR442168 administered alone and together with rifampicin. 1 day washout for each administration of SAR442168.

Primary Outcome Measure

Pharmacokinetics: AUClast of SAR442168 [ Time Frame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Prism Research-Site Number:8400001Saint PaulMinnesota55144-

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