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

Nobelpharma Co., Ltd.

Status and phase: Completed; Phase 1

Conditions: Qt Interval, Variation in

Treatments: Drug: NPC-15 and/or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03475459

NPC-15-7

Details and patient eligibility

About

A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg)

Full 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 period, eligible volunteers wll be administered placebo, NPC-15 4g (melatonin 8mg) and NPC-15 8g(melatonin 16mg) as a sequential manner.

Enrollment: 12 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

study drug

Experimental group

Description:

Study drug (NPC-15 and/or Placebo ) will be orally administered once with 200 ml of water at 20:00 on the first days of Period I, Period II and Period III.

Treatment:

Drug: NPC-15 and/or Placebo