Investigation of Arrhythmogenic Effect of NPC-15 (NPC-15-7)

Launched by NOBELPHARMA · Mar 16, 2018

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject with BMI ≥ 17.6 kg/m2 and \< 30.0 kg/m2.
• • Subject who falls asleep at between 21:00 and 25:00 and wakes up at between 5:00 and 9:00 during 1 week prior to the first study drug administration.
• • Subject who is able to comply with the study requirements during the study period.
• Exclusion Criteria:
• • Subject with QTcF interval greater than 450 ms in male or greater than 470 ms in female on the 12-lead electrocardiogram (ECG), or with clinically significant ECG abnormalities in other findings.
• • Subject who has a family history of Torsades de Pointes (TdP) or long QT syndrome.
• • Subject who has a history of hypersensitivity or allergies to melatonin or ramelteon.
• • Subject who has a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments.
• • Subject who received any non-prescription or prescription drug within 2 weeks prior to the first study drug administration.
• • Subject who received any product containing St Jones Wart or any supplement containing melatonin within 4 weeks prior to the first study drug administration.
• • Subject who has a history of smoking habit or was possibly exposed to passive smoking on a daily basis within 24 weeks prior to the first study drug administration.
• • Subject who, in the opinion of the investigator or sub-investigator, is unsuitable to be involved in the study.