Clinical trial NCT06106074: Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-10-30
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Part 1a and Part 2: Number of participants with Adverse Events (AEs) and treatment-emergent adverse events (TEAEs)
timeFrame: Part 1a: Day 1 to approximately Day 14 Part 2: Day 1 to approximately Day 21
measure: Part 1b: Total (free and bound) SAR442168 concentrations in CSF
timeFrame: From Day 1 to Day 3
measure: Part 1b: Total (free and bound) SAR442168 metabolite(s) concentrations in CSF
timeFrame: From Day 1 to Day 3
measure: Part 1c and Part 1d: Maximum plasma concentration observed (Cmax) ratio fed/fast of SAR442168
timeFrame: From Day 1 to Day approximately 14
measure: Part 1c and Part1d: Cmax ratio fed/fasted of SAR442168 metabolite(s)
timeFrame: From Day 1 to Day approximately 14
measure: Part 1c and Part 1d: Area under the plasma concentration versus time curve (AUC) ratio fed/fast of SAR442168
timeFrame: From Day 1 to Day approximately 14
measure: Part 1c and Part1d: AUC ratio fed/fast of SAR442168 metabolite(s)
timeFrame: From Day 1 to Day approximately 14
Secondary outcomes:
measure: All Parts: Cmax of SAR442168
timeFrame: From Day 1 to Day approximately 14
measure: All Parts: Cmax of SAR442168 metabolite(s)
timeFrame: From Day 1 to Day approximately 14
measure: Part 1a, Part 1b and Part 2: tmax of SAR442168
timeFrame: From Day 1 to Day approximately 14
measure: Part 1a, Part 1b and Part 2: tmax of SAR442168 metabolite(s)
timeFrame: From Day 1 to Day approximately 14
measure: Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168
timeFrame: From Day 1 to Day approximately 14
measure: Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168 metabolite(s)
timeFrame: From Day 1 to Day approximately 14
measure: Part 2: AUC0-tau for SAR442168
timeFrame: From Day 1 to Day approximately 14
measure: Part 2: AUC0-tau for SAR442168 metabolite(s)
timeFrame: From Day 1 to Day approximately 14
measure: Part 1b, Part1c and 1d: Number of participants with Adverse Events (AEs) and treatment-emergent adverse events (TEAEs)
timeFrame: From Day 1 to Day approximately 14
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: New Orleans Clinical Research Site Number : 8400001
state: Tennessee
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: