This is a Phase 1, single-center study conducted in 2 parts: Part 1a, single ascending dose (SAD-TDU16519): Double-blind, randomized, placebo-controlled sequential ascending single oral doses including up to 6 cohorts. Each cohort will include 8 participants (6 receiving SAR443820 and 2 placebo). Part 1b (TDU16519): - Open label, single SAR443820 dose in one or two separated cohort(s) for SAR443820 measurements in CSF and in plasma. Part 2, multiple ascending dose (MAD -TDR16520): Double-blind, randomized, placebo-controlled, sequential ascending repeated oral doses for 14 days, including up to 4 cohorts. Each cohort will include 10 participants (8 receiving SAR443820 and 2 placebo).
The duration of the study for a participant will include: Screening Period: up to 28 days Part 1a: Treatment in fasted condition: 1 day (Day 1). Study observation Period from Day -2/Day -1 to Day 3. Follow-up with the end of study: from Day 5 to Day 7. Total duration from screening per participant: up to 5 weeks. Part 1b: Treatment in fed condition: 1 day (Day 1). Study observation Period from Day -1/Day1 to Day 2. Follow-up with the end of study: from Day 5 to Day 7. Total duration from screening per participant: up to 5 weeks. Part 2: Treatment: 14 days (Day 1 to Day 14). Study observation Period from Day -2/Day -1 to Day 17. Follow-up with the end of study: from Day 19 to Day 21. Total duration from screening per participant: up to 7 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Prism Research-Site Number:8400001
Saint Paul, Minnesota, United States
Parts 1a and 1b: Number of participants with adverse events
Time frame: Day1 up to Day 7 (end of study visit)
Part 2: Number of participants with adverse events
Time frame: Day1 up to Day 21 (end of study visit)
Parts 1a and 1b: Assessment of pharmacokinetic parameter of SAR443820: Cmax in plasma
Parts 1a and 1b: Maximum plasma concentration
Time frame: Day1
Parts 1a and 1b: Assessment of pharmacokinetic parameter of SAR443820: tmax in plasma
Parts 1a and 1b: time to reach Cmax
Time frame: Day 1
Parts 1a and 1b : Assessment of pharmacokinetic parameter of SAR443820: AUC in plasma
Parts 1a and 1b: Area under the plasma concentration versus time
Time frame: Day1
Parts 1a and 1b : Assessment of pharmacokinetic parameter of SAR443820: t1/2z in plasma
Terminal half-life in plasma
Time frame: Day1
Part1b: SAR443820 concentrations in cerebrospinal fluid (CSF) samples
Part 1b: CSF to plasma concentration ratio
Time frame: Day1
Part 2: Assessment of pharmacokinetic parameter of SAR443820: Cmax in plasma
Part 2: Maximum plasma concentration
Time frame: Day1 and Day14
Part 2: Assessment of pharmacokinetic parameter of SAR443820: tmax in plasma
Part 2: Time to reach Cmax
Time frame: Day1 and Day14
Part 2: Assessment of pharmacokinetic parameter of SAR443820: AUC tau in plasma
Part 2: Area under the plasma concentration versus time during a dosing interval
Time frame: Day1 and Day14
Part 2 Assessment of pharmacokinetic parameter of SAR443820: t1/2z in plasma
Terminal half-life in plasma
Time frame: Day14
Part 2: Day14/Day1 of 4β-hydroxycholesterol ratio in plasma
D14/D1 of 4β-hydroxycholesterol ratio
Time frame: Day1 and Day14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.