Skip to main content
OpenTrials
Completed

NCT Number: NCT06106074

Study of the Tolerability and Pharmacokinetics of 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Orleans Clinical Research Site Number : 8400001

Knoxville, Tennessee, 37920, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

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.

Treatment and study plan

Tolebrutinib

Drug

Tablet, oral

Other names: SAR442168

Placebo

Drug

Tablet, oral

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

    Time frame: From Day 1 to Day approximately 14

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

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

    Time frame: From Day 1 to Day approximately 14

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

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 30, 2023
Registry last updated
Oct 30, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.