This is a 3-part study of S-740792 in healthy adult participants. Part 1 (single-ascending-dose and food effect) will investigate the safety, tolerability, and pharmacokinetics (PK) of S-740792. Part 2 (multiple-ascending-dose and drug-drug interaction) will investigate the safety, tolerability, and PK of S-740792, in addition, the effect of multiple doses of S-740792 on the PK of midazolam. Part 3 will investigate the relative bioavailability of S-740792 tablet compared to S-740792 suspension and the food effect on the PK of the S-740792 tablet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
99
Fortrea Clinical Research Unit, Inc.
Daytona Beach, Florida, United States
Parts 1 and 2: Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 28
Part 3: Plasma Concentration of S-740792
Time frame: Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)
Part 3: Time to Maximum Plasma Concentration (Tmax) of S-740792
Time frame: Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)
Parts 1 and 2: Plasma Concentration of S-740792
Time frame: Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28
Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of S-740792
Time frame: Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28
Part 1: Plasma Concentration of S-740792 After a High-fat Meal
Time frame: Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14
Part 1: Tmax of S-740792 After a High-fat Meal
Time frame: Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14
Part 2: Plasma Concentration of Midazolam After Administration of S-740792
Time frame: Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)
Part 2: Tmax of Midazolam After Administration of S-740792
Time frame: Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will receive S-740792 as an oral tablet.
Part 3: Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 62