Investigation of Arrhythmogenic Effect of NPC-15 (NPC-15-7) (NCT03475459) | Clinical Trial Compass
CompletedPhase 1
Investigation of Arrhythmogenic Effect of NPC-15 (NPC-15-7)
Japan12 participantsStarted 2018-04-03
Plain-language summary
A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg)
Who can participate
Age range20 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Time matched, baseline-adjusted change in Fridericia-corrected QTc (QTcF) intervals
Timeframe: Day1 and Day2 of each periods (3 periods)