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CompletedNCT06106074Updated Oct 30, 2023

Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants

A Phase 1 interventional study of Tolebrutinib and Placebo in Multiple Sclerosis, sponsored by Sanofi. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-30.

Sponsored by Sanofi · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2022, 4 years 4 months ago, and no results have been posted to the registry.
  • Registered 3 years 2 months after the study started (first participant enrolled Aug 2020, registered Oct 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This is a randomized, placebo-controlled, four-part, Phase I, first in human (FIH) study to assess the tolerability and pharmacokinetics (PK) of ascending single and 14-day repeated oral doses of SAR442168 with a food effect investigation in healthy adult participants.

  • In Part 1a: The tolerability and safety of SAR442168 and the pharmacokinetic parameters of SAR442168 and metabolite(s)after ascending single oral doses in fasted and fed conditions
  • In Part 1b: The relationship of PK of SAR442168 and metabolite(s) in cerebrospinal fluid (CSF) to that in plasma after single oral doses given in fed conditions (moderate-fat meal)
  • In Part 1c: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (high-fat)
  • In Part 1d: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (standardized high-fat meal)
  • In Part 2: The tolerability and safety of SAR442168 and the pharmacokinetic parameters of SAR442168 and metabolite(s) after 14-day ascending repeated oral doses of SAR442168 given in fed conditions (moderate-fat meal).
02

Conditions studied

  • Multiple Sclerosis

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03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 71 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Having given written informed consent prior to undertaking any study-related procedure.

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    Part 1a

    3 single ascending doses of SAR442168 or placebo in fasted and fed (high-fat breakfast) conditions

    Drug: Tolebrutinib · Drug: Placebo

  • Experimental
    Part 1b

    2 single doses of SAR442168 under fed conditions (moderate-fat breakfast).

    Drug: Tolebrutinib

  • Experimental
    Part 1c

    1 single dose of SAR442168 under fasting and fed conditions (high-fat breakfast).

    Drug: Tolebrutinib

  • Experimental
    Part 1d

    1 single dose of SAR442168 under fasting and fed conditions (Standardized high-fat breakfast).

    Drug: Tolebrutinib

  • Experimental
    Part 2

    3 ascending once-daily repeated single doses of SAR442168 or placebo for 14 days under fed conditions (moderate-fat breakfast)

    Drug: Tolebrutinib · Drug: Placebo

Interventions

  • DrugTolebrutinib

    Tablet, oral

    Also known as: SAR442168

  • DrugPlacebo

    Tablet, oral

06

What researchers measure

Primary outcomes

  1. Part 1a and Part 2: Number of participants with Adverse Events (AEs) and treatment-emergent adverse events (TEAEs)

    Time frame: Part 1a: Day 1 to approximately Day 14 Part 2: Day 1 to approximately Day 21

  2. Part 1b: Total (free and bound) SAR442168 concentrations in CSF

    Time frame: From Day 1 to Day 3

  3. Part 1b: Total (free and bound) SAR442168 metabolite(s) concentrations in CSF

    Time frame: From Day 1 to Day 3

  4. Part 1c and Part 1d: Maximum plasma concentration observed (Cmax) ratio fed/fast of SAR442168

    Time frame: From Day 1 to Day approximately 14

  5. Part 1c and Part1d: Cmax ratio fed/fasted of SAR442168 metabolite(s)

    Time frame: From Day 1 to Day approximately 14

  6. Part 1c and Part 1d: Area under the plasma concentration versus time curve (AUC) ratio fed/fast of SAR442168

    Time frame: From Day 1 to Day approximately 14

  7. Part 1c and Part1d: AUC ratio fed/fast of SAR442168 metabolite(s)

    Time frame: From Day 1 to Day approximately 14

Secondary outcomes

  1. All Parts: Cmax of SAR442168

    Time frame: From Day 1 to Day approximately 14

  2. All Parts: Cmax of SAR442168 metabolite(s)

    Time frame: From Day 1 to Day approximately 14

  3. Part 1a, Part 1b and Part 2: tmax of SAR442168

    Time frame: From Day 1 to Day approximately 14

  4. Part 1a, Part 1b and Part 2: tmax of SAR442168 metabolite(s)

    Time frame: From Day 1 to Day approximately 14

  5. Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168

    Time frame: From Day 1 to Day approximately 14

  6. Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168 metabolite(s)

    Time frame: From Day 1 to Day approximately 14

  7. Part 2: AUC0-tau for SAR442168

    Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours)

    Time frame: From Day 1 to Day approximately 14

  8. Part 2: AUC0-tau for SAR442168 metabolite(s)

    Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours)

    Time frame: From Day 1 to Day approximately 14

  9. Part 1b, Part1c and 1d: Number of participants with Adverse Events (AEs) and treatment-emergent adverse events (TEAEs)

    Time frame: From Day 1 to Day approximately 14

07

Study locations

1 site
  • New Orleans Clinical Research Site Number : 8400001
    Knoxville, Tennessee 37920, United States
08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06106074
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Oct 30, 2023
Start date
Aug 10, 2020
Primary completion
May 23, 2022
Completion
May 23, 2022
Last update
Oct 30, 2023

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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