The purpose of this study is to investigate the safety and tolerability of MB12066 after a single or multiple oral dose and to investigate the pharmacokinetic characteristics of MB12066 after a single or multiple oral dose.
* Safety/ Tolerability evaluation Adverse events, Physical examinations, Vital signs, ECG (including continuous ECG monitoring), Laboratory tests (including hematology, chemistry, coagulation, PBS, NAD(P)+/NAD(P)H ratio, urinalysis), CIC * Pharmacokinetic Evaluation(single) * Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted between 0 (pre-dose) and 96 hours after a single oral dose. * Blood sampling time pre-dose, 0.5, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h post-dose * Urine collection time 0h - 6h, 6h - 12h, 12h - 24h, 24h - 48h, 48h - 72h * Evaluation parameters AUClast, AUCinf, Cmax, Tmax, t1/2, Vd/F, CL/F, Ae, fe, CLR * Pharmacokinetic Evaluation(multiple) * Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted after a single oral dose and Steady state. * Blood sampling time Day 1 pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, Day3-6 Pre-dose, Day7 Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h post-dose * Urine collection time Day 1 Pre-dose, 0h - 6h, 6h - 12h, 12h - 24h, Day 7 Pre-dose, 0h - 6h, 6h - 12h, 12h - 24h * Evaluation parameters Cmax,ss, Cmin,ss, Cav,ss, AUCτ, Tmax,ss, t1/2, PTF(peak to trough fluctuation ratio), fe, CLss/F, CLR
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Enrollment
40
Clinical Research Institute of Seoul National University Hospital
Seoul, Daehang-ro, Jongno-Gu, South Korea
Number of participants with adverse events (single dose)
Adverse events
Time frame: Single dose: from day-1 to day8-10
Number of Patients with with Adverse Events (Multiple Dose)
Adverse Events
Time frame: Multiple dose: from day-1 to day15-17
Composite of Pharmacokinetic Evaluation (single dose)
Single oral dose * Blood sampling time pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h post-dose * Urine collection time 0h - 6h, 6h - 12h, 12h - 24h, 24h - 48h, 48h - 72h Evaluation parameters Cmax,ss, Cmin,ss, Cav,ss, AUCτ, Tmax,ss, t1/2, PTF(peak to trough fluctuation ratio), fe, CLss/F, CLR
Time frame: between 0 (pre-dose) and 72 hours after a single oral dose.
Composite of Pharmacokinetic Evaluation (multiple dose)
Multiple oral dose * Blood sampling time Day 1 pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h post-dose Day 3-6 pre-dose Day 7 pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h post-dose * Urine collection time Day 1 0h - 6h, 6h - 12h, 12h - 24h Day 7 0h - 6h, 6h - 12h, 12h - 24h Evaluation parameters Cmax,ss, Cmin,ss, Cav,ss, AUCτ, Tmax,ss, t1/2, PTF(peak to trough fluctuation ratio), fe, CLss/F, CLR
Time frame: between 0 (pre-dose) and 24 hours and between 7day and 11 day after a multiple oral dose.
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MB12066 200mg
Placebo 300mg (single dose), 400mg (single dose), 100mg (multiple dose), 200mg (multiple dose)