Multiple SclerosisPhase 1NCT06064539
Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects
A Phase 1 study testing Tolebrutinib, gemfibrozil and rifampicin in people with Multiple Sclerosis, run by Sanofi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Tolebrutinib, gemfibrozil and rifampicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2020to 8 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Prism Research-Site Number:8400001
Saint Paul, Minnesota, 55144
About this study
Official 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
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.
Read the detailed description
Study duration per participant approximately 16 days for Cohort 1 and approximately 18 days for Cohort 2.
- Conditions
- Multiple Sclerosis
- Being tested
- Tolebrutinib, gemfibrozil, rifampicin
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolebrutinibDrug
Tablet, taken orally
gemfibrozilDrug
Tablet, taken orally
rifampicinDrug
Tablet, taken orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | SAR442168 administered alone and together with gemfibrozil. 1 day washout for each administration of SAR442168. Receives: Drug: Tolebrutinib; Drug: gemfibrozil |
| Cohort 2 | Experimental | SAR442168 administered alone and together with rifampicin. 1 day washout for each administration of SAR442168. Receives: Drug: Tolebrutinib; Drug: rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: AUClast of SAR442168
AUC up to the last measurable concentration
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Pharmacokinetics: Cmax of gemfibrozil
Measured: From Day 1 to Day 7 of Period 2
Pharmacokinetics: Cmax of gemfibrozil 1-O-glucuronide
Measured: From Day 1 to Day 7 of Period 2
Pharmacokinetics: tmax of gemfibrozil
Measured: From Day 1 to Day 7 of Period 2
Pharmacokinetics: tmax of gemfibrozil 1-O-glucuronide
Measured: From Day 1 to Day 7 of Period 2
Pharmacokinetics: Cmax of rifampicin
Measured: From Day 1 to Day 9 of Period 2
Pharmacokinetics: tmax of rifampicin
Measured: From Day 1 to Day 9 of Period 2
Numbers of participants with adverse events (AEs)
Measured: From baseline to End of Study (i.e. Period 2 Day 16 days in Cohort 1, and Period 2 Day18 days in Cohort 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start18 May 2020
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064539
- Sponsor's protocol ID
- INT16726
- Other IDs
- U1111-1244-2759
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06064539
- Acronym / sponsor ID
- INT16726
- Conditions
- Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 18 May 2020 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Tolebrutinib, Drug: gemfibrozilSAR442168 administered alone and together with gemfibrozil. 1 day washout for each administration of SAR442168. |
| Cohort 2 | Experimental | Drug: Tolebrutinib, Drug: rifampicinSAR442168 administered alone and together with rifampicin. 1 day washout for each administration of SAR442168. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolebrutinibTablet, taken orally | Drug | Cohort 1, Cohort 2 |
| gemfibrozilTablet, taken orally | Drug | Cohort 1 |
| rifampicinTablet, taken orally | Drug | Cohort 2 |
Primary outcome
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
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
12 secondary outcomes
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
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
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
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
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
Pharmacokinetics: Cmax of gemfibrozil
Time frame: From Day 1 to Day 7 of Period 2
Pharmacokinetics: Cmax of gemfibrozil 1-O-glucuronide
Time frame: From Day 1 to Day 7 of Period 2
Pharmacokinetics: tmax of gemfibrozil
Time frame: From Day 1 to Day 7 of Period 2
Pharmacokinetics: tmax of gemfibrozil 1-O-glucuronide
Time frame: From Day 1 to Day 7 of Period 2
Pharmacokinetics: Cmax of rifampicin
Time frame: From Day 1 to Day 9 of Period 2
Pharmacokinetics: tmax of rifampicin
Time frame: From Day 1 to Day 9 of Period 2
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- INT16726 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tolebrutinib, gemfibrozil and rifampicin in people with Multiple Sclerosis, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.