The aim of this study is to investigate different formulations of S-337395.
This single-center study comprises an open-label, randomized, crossover study, and a double-blinded, placebo-controlled, randomized, multiple-dose study to examine the relative bioavailability, food effect, pharmacokinetics, safety, and tolerability of different formulations of S-337395.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
50
ICON Lenexa
Lenexa, Kansas, United States
Part A: Plasma Concentration of S-337395
Time frame: Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose)
Part B: Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 21
Part A: Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 29
Part A: Plasma Concentration of S-337395 (Venous Samples Versus Capillary Microsamples)
Time frame: Venous: Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose); Capillary: Days 1, 2, 8, and 9 (Up to 24 hours post dose)
Part B: Plasma Concentration of S-337395
Time frame: Days 1-12 (Predose, up to 96 hours post dose)
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