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

NCT06064539 | Completed Phase 1 FDA Drug

• 2 other identifiers: INT16726U1111-1244-2759
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: AUClast of SAR442168

  AUC up to the last measurable concentration

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

• Pharmacokinetics: AUC of SAR442168

  Area under the curve, reflects the concentration of drug

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

Secondary Outcomes (12)

• Pharmacokinetics: Maximum plasma concentration observed (Cmax) of SAR442168

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

• Pharmacokinetics: Cmax of SAR442168 metabolite(s)

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

• Pharmacokinetics: AUC of SAR442168 metabolite(s)

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

• Pharmacokinetics: Time to reach Cmax (tmax) of SAR442168

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

• Pharmacokinetics: tmax of SAR442168 metabolite(s)

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

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Drug: Tolebrutinib; Drug: gemfibrozil

Cohort 2

EXPERIMENTAL

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

Drug: Tolebrutinib; Drug: rifampicin

Interventions

Tolebrutinib DRUG

Tablet, taken orally

Cohort 1; Cohort 2

gemfibrozil DRUG

Tablet, taken orally

Cohort 1

rifampicin DRUG

Tablet, taken orally

Cohort 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Prism Research-Site Number:8400001

Saint Paul, Minnesota, 55144, United States

Location

Related Links

• INT16726 Plain Language Results Summary

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Gemfibrozil; Rifampin

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Pentanoic Acids; Valerates; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Volatile; Fatty Acids; Lipids; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: May 18, 2020
• Primary Completion: July 8, 2020
• Study Completion: July 8, 2020
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)