Status:
COMPLETED
Investigation of Arrhythmogenic Effect of NPC-15 (NPC-15-7)
Lead Sponsor:
Nobelpharma
Conditions:
Qt Interval, Variation in
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg)
Detailed Description
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 peri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03475459
Start Date
April 3 2018
End Date
April 29 2018
Last Update
June 28 2018
Active Locations (1)
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1
SOUSEIKAI Hakata Clinic
Fukuoka, Japan, 8120025