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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis

Treatments: Drug: Placebo; Drug: Tolebrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06106074

TDU16831-TDR16862

Details and patient eligibility

About

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).

Enrollment: 71 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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71 participants in 5 patient groups

Part 1a

Experimental group

Description:

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

Treatment:

Drug: Tolebrutinib

Drug: Placebo

Part 1b

Experimental group

Description:

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

Treatment:

Drug: Tolebrutinib

Part 1c

Experimental group

Description:

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

Treatment:

Drug: Tolebrutinib

Part 1d

Experimental group

Description:

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

Treatment:

Drug: Tolebrutinib

Part 2

Experimental group

Description:

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

Treatment:

Drug: Tolebrutinib

Drug: Placebo