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Completed

NCT Number: NCT06064539

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

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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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Prism Research-Site Number:8400001

Saint Paul, Minnesota, 55144, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tolebrutinib

Drug

Tablet, taken orally

Gemfibrozil

Drug

Tablet, taken orally

rifampicin

Drug

Tablet, taken orally

Primary outcomes

  1. 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

    AUC up to the last measurable concentration

  2. Pharmacokinetics: AUC of SAR442168

    Time frame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2

    Area under the curve, reflects the concentration of drug

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Pharmacokinetics: Cmax of gemfibrozil

    Time frame: From Day 1 to Day 7 of Period 2

  7. Pharmacokinetics: Cmax of gemfibrozil 1-O-glucuronide

    Time frame: From Day 1 to Day 7 of Period 2

  8. Pharmacokinetics: tmax of gemfibrozil

    Time frame: From Day 1 to Day 7 of Period 2

  9. Pharmacokinetics: tmax of gemfibrozil 1-O-glucuronide

    Time frame: From Day 1 to Day 7 of Period 2

  10. Pharmacokinetics: Cmax of rifampicin

    Time frame: From Day 1 to Day 9 of Period 2

  11. Pharmacokinetics: tmax of rifampicin

    Time frame: From Day 1 to Day 9 of Period 2

  12. 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)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 3, 2023
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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