The objective of this trial is to evaluate the safety and tolerability of single and multiple ascending oral doses of OPS-2071 in healthy male Korean
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
96
single oral dose under fasted condition
single oral dose under fasted condition
multiple twice-daily oral dosing for 5-7days
Seoul National University Hospital
Seoul, South Korea
Part1 : adverse event, body weight, physical examination, vital sign, electrocardiogram, clinical laboratory test
Time frame: 4days
Part2 : adverse event, body weight, physical examination, vital sign, electrocardiogram, clinical laboratory test, Bond and Lader visual analogue scale (BL VAS)
Bond and Lader VAS: Day -1 and last dosing day (within 1 hour of expected Cmax)
Time frame: 21days
Part1 : Plasma pharmacokinetic parameters of OPS-2071
Cmax, tmax, AUC and so on.
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Part2 : Plasma Pharmacokinetic parameters of OPS-2071
Cmax, tmax, AUCtau, C12 and so on.
Time frame: Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-morning-dose , Days 2 to 6: pre morning and evening dose, last dosing day: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose.
Part1 : Urine Pharmacokinetic parameter of OPS-2071
Time frame: Day 1: pre-dose, 0-4, 4-8, 8-12, 12-24, 24-48 and 48-72 hours post-dose
Part2 : Urine pharmacokinetic parameter of OPS-2071
Time frame: Day 1 and last dosing day : pre-morning dose, 0-4 post-morning dose, 4-8 post-morning dose and 8-12 hours post-morning dose.
Part1 : Fecal pharmacokinetic parameters of OPS-2071
Feces sample is collected in the 120-mg group only: All post-dose samples will be collected until discharge. Actual sampling time point will be recorded.
Time frame: All post-dose samples
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multiple twice-daily oral dosing for 5-7days
Part2 : Microflora test
Time frame: Pre-dose, last dosing day to the day of discharge,. Day 21