Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants
- Conditions
- Multiple Sclerosis
- Interventions
- Drug: TolebrutinibDrug: Placebo
- Registration Number
- NCT06106074
- Lead Sponsor
- Sanofi
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- Having given written informed consent prior to undertaking any study-related procedure.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1a Tolebrutinib 3 single ascending doses of SAR442168 or placebo in fasted and fed (high-fat breakfast) conditions Part 1a Placebo 3 single ascending doses of SAR442168 or placebo in fasted and fed (high-fat breakfast) conditions Part 1b Tolebrutinib 2 single doses of SAR442168 under fed conditions (moderate-fat breakfast). Part 1c Tolebrutinib 1 single dose of SAR442168 under fasting and fed conditions (high-fat breakfast). Part 1d Tolebrutinib 1 single dose of SAR442168 under fasting and fed conditions (Standardized high-fat breakfast). Part 2 Tolebrutinib 3 ascending once-daily repeated single doses of SAR442168 or placebo for 14 days under fed conditions (moderate-fat breakfast) Part 2 Placebo 3 ascending once-daily repeated single doses of SAR442168 or placebo for 14 days under fed conditions (moderate-fat breakfast)
- Primary Outcome Measures
Name Time Method Part 1a and Part 2: Number of participants with Adverse Events (AEs) and treatment-emergent adverse events (TEAEs) Part 1a: Day 1 to approximately Day 14 Part 2: Day 1 to approximately Day 21 Part 1b: Total (free and bound) SAR442168 concentrations in CSF From Day 1 to Day 3 Part 1b: Total (free and bound) SAR442168 metabolite(s) concentrations in CSF From Day 1 to Day 3 Part 1c and Part 1d: Maximum plasma concentration observed (Cmax) ratio fed/fast of SAR442168 From Day 1 to Day approximately 14 Part 1c and Part1d: Cmax ratio fed/fasted of SAR442168 metabolite(s) From Day 1 to Day approximately 14 Part 1c and Part 1d: Area under the plasma concentration versus time curve (AUC) ratio fed/fast of SAR442168 From Day 1 to Day approximately 14 Part 1c and Part1d: AUC ratio fed/fast of SAR442168 metabolite(s) From Day 1 to Day approximately 14
- Secondary Outcome Measures
Name Time Method All Parts: Cmax of SAR442168 metabolite(s) From Day 1 to Day approximately 14 All Parts: Cmax of SAR442168 From Day 1 to Day approximately 14 Part 1a, Part 1b and Part 2: tmax of SAR442168 From Day 1 to Day approximately 14 Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168 metabolite(s) From Day 1 to Day approximately 14 Part 2: AUC0-tau for SAR442168 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)
Part 2: AUC0-tau for SAR442168 metabolite(s) 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)
Part 1b, Part1c and 1d: Number of participants with Adverse Events (AEs) and treatment-emergent adverse events (TEAEs) From Day 1 to Day approximately 14 Part 1a, Part 1b and Part 2: tmax of SAR442168 metabolite(s) From Day 1 to Day approximately 14 Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168 From Day 1 to Day approximately 14
Trial Locations
- Locations (1)
New Orleans Clinical Research Site Number : 8400001
🇺🇸Knoxville, Tennessee, United States