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

NCT ID: NCT03475459

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2018-04-29

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

Conditions

Qt Interval, Variation in

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study drug

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.

Group Type: EXPERIMENTAL

NPC-15 and/or Placebo

Intervention Type: DRUG

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)

Interventions

NPC-15 and/or Placebo

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)

Intervention Type: DRUG

Other Intervention Names

Melatonin and/or Placebo

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nobelpharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masaharu Hayashi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shukutoku University

Locations

SOUSEIKAI Hakata Clinic

Fukuoka, , Japan

Countries

Japan

Other Identifiers

NPC-15-7

Identifier Type: -

Identifier Source: org_study_id