A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg)
This study is a single center, open label, dose escalation trial to evaluate prolongation effect on QT interval of NPC-15 (melatonin 8mg or 16mg). The trial compose of 3 periods; During the each period, eligible volunteers wll be administered placebo, NPC-15 4g (melatonin 8mg) and NPC-15 8g(melatonin 16mg) as a sequential manner.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
The dosage and regimen of the study drug in each period is the following. Period I : NPC-15 placebo granules 8 g Period II : NPC-15 placebo granules 4 g + NPC-15 granules 0.2% 4 g (melatonin 8 mg) Period III : NPC-15 granules 0.2% 8 g (melatonin 16 mg)
SOUSEIKAI Hakata Clinic
Fukuoka, Japan
Time matched, baseline-adjusted change in Fridericia-corrected QTc (QTcF) intervals
QTcF interval is a common endpoints to evaluate arrhythmogenic effect of test drug
Time frame: Day1 and Day2 of each periods (3 periods)
Serum melatonin concentration
NPC-15 is a preparation containing melatonin , therefore the change in blood concentration of melatonin is useful to evaluate the QTc prolongation effect of NPC-15.
Time frame: Up to 12 hours post dose in each period (3 periods)
Maximum drug concentration (Cmax) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Time frame: Up to 12 hours post dose in each period (3 periods)
Maximum drug concentration time (Tmax) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Time frame: Up to 12 hours post dose in each period (3 periods)
Area under the blood concentration time curve (AUC) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Time frame: Up to 12 hours postdose in each period (3 periods)
Terminal elimination rate constant (λz) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Time frame: Up to 12 hours post dose in each period (3 periods)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mean residence time (MRT) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Time frame: Up to 12 hours postdose in each period (3 periods)
Elimination half-life (t1/2) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Time frame: Up to 12 hours post dose in each period
Clearance (CL) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Time frame: Up to 12 hours post dose in each period (3 periods)
Volume of distribution (Vd) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Time frame: Up to 12 hours postdose in each period (3 periods)
Adverse Events
All events that emerge during treatment, having been absent pretreatment, or worsens relative to the pretreatment state
Time frame: Up to 36 hours post dose of Period III