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

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
Sanofi
Study ID
NCT06106074
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Tolebrutinib — DRUG
    Tablet, oral
  • Placebo — DRUG
    Tablet, oral

Study Details

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).

Key Dates

Start date
Aug 10, 2020
Status verified
Oct 2023
Primary completion
May 23, 2022
Completion
May 23, 2022

Study Design

Enrollment
71 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1a
    3 single ascending doses of SAR442168 or placebo in fasted and fed (high-fat breakfast) conditions
  • Experimental: Part 1b
    2 single doses of SAR442168 under fed conditions (moderate-fat breakfast).
  • Experimental: Part 1c
    1 single dose of SAR442168 under fasting and fed conditions (high-fat breakfast).
  • Experimental: Part 1d
    1 single dose of SAR442168 under fasting and fed conditions (Standardized high-fat breakfast).
  • Experimental: Part 2
    3 ascending once-daily repeated single doses of SAR442168 or placebo for 14 days under fed conditions (moderate-fat breakfast)

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
New Orleans Clinical Research Site Number : 8400001KnoxvilleTennessee37920-

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