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Multiple SclerosisPhase 1NCT06106074

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

A Phase 1 study testing Tolebrutinib in people with Multiple Sclerosis, run by Sanofi at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Multiple Sclerosis
What is being tested?
Tolebrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
71 participants
Where
1 siteUnited States
Study dates
10 Aug 2020to 23 May 2022
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

  • New Orleans Clinical Research Site Number : 8400001

    Knoxville, Tennessee, 37920

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study of the Tolerability and Pharmacokinetics of Ascending Single and 14-day Repeated Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants

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).
Being tested
Tolebrutinib, Placebo
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

    Also called SAR442168

    Tablet, oral

  • PlaceboDrug

    Tablet, oral

Study groups in NCT06106074
Study groupRoleWhat they receive
Part 1aExperimental3 single ascending doses of SAR442168 or placebo in fasted and fed (high-fat breakfast) conditions
Receives: Drug: Tolebrutinib; Drug: Placebo
Part 1bExperimental2 single doses of SAR442168 under fed conditions (moderate-fat breakfast).
Receives: Drug: Tolebrutinib
Part 1cExperimental1 single dose of SAR442168 under fasting and fed conditions (high-fat breakfast).
Receives: Drug: Tolebrutinib
Part 1dExperimental1 single dose of SAR442168 under fasting and fed conditions (Standardized high-fat breakfast).
Receives: Drug: Tolebrutinib
Part 2Experimental3 ascending once-daily repeated single doses of SAR442168 or placebo for 14 days under fed conditions (moderate-fat breakfast)
Receives: Drug: Tolebrutinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

    Measured: From Day 1 to Day 3

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

    Measured: From Day 1 to Day 3

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

    Measured: From Day 1 to Day approximately 14

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

    Measured: 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

    Measured: From Day 1 to Day approximately 14

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

    Measured: From Day 1 to Day approximately 14

Secondary outcomes (9)

  1. All Parts: Cmax of SAR442168

    Measured: From Day 1 to Day approximately 14

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

    Measured: From Day 1 to Day approximately 14

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

    Measured: From Day 1 to Day approximately 14

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

    Measured: From Day 1 to Day approximately 14

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

    Measured: From Day 1 to Day approximately 14

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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: From Day 1 to Day approximately 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start10 Aug 2020
  3. Primary completion23 May 2022
  4. Study completion23 May 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06106074
Sponsor's protocol ID
TDU16831-TDR16862
Status last verified
Oct 2023
First submitted
24 Oct 2023
Last updated
30 Oct 2023
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tolebrutinib 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 1 inclusion and 2 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 30 Oct 2023. 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?

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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06106074.

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 30 Oct 2023.

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