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

NCT ID: NCT06106074

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-10
• Study Completion Date: 2022-05-23

Brief 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).

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Part 1a

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

Group Type: EXPERIMENTAL

Tolebrutinib

Intervention Type: DRUG

Tablet, oral

Placebo

Intervention Type: DRUG

Tablet, oral

Part 1b

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

Group Type: EXPERIMENTAL

Tolebrutinib

Intervention Type: DRUG

Tablet, oral

Part 1c

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

Group Type: EXPERIMENTAL

Tolebrutinib

Intervention Type: DRUG

Tablet, oral

Part 1d

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

Group Type: EXPERIMENTAL

Tolebrutinib

Intervention Type: DRUG

Tablet, oral

Part 2

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

Group Type: EXPERIMENTAL

Tolebrutinib

Intervention Type: DRUG

Tablet, oral

Placebo

Intervention Type: DRUG

Tablet, oral

Interventions

Tolebrutinib

Tablet, oral

Intervention Type: DRUG

Placebo

Tablet, oral

Intervention Type: DRUG

Other Intervention Names

SAR442168

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

New Orleans Clinical Research Site Number : 8400001

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

TDU16831-TDR16862

Identifier Type: -

Identifier Source: org_study_id