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

NCT03475459 | Completed Phase 1

• 1 other identifier: NPC-15-7
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Qt Interval, Variation in

Keywords

QTc prolongation effect

Outcome Measures

Primary Outcomes (1)

• Time matched, baseline-adjusted change in Fridericia-corrected QTc (QTcF) intervals

  QTcF interval is a common endpoints to evaluate arrhythmogenic effect of test drug

  Day1 and Day2 of each periods (3 periods)

Secondary Outcomes (10)

• Serum melatonin concentration

  Up to 12 hours post dose in each period (3 periods)

• Maximum drug concentration (Cmax) of melatonin

  Up to 12 hours post dose in each period (3 periods)

• Maximum drug concentration time (Tmax) of melatonin

  Up to 12 hours post dose in each period (3 periods)

• Area under the blood concentration time curve (AUC) of melatonin

  Up to 12 hours postdose in each period (3 periods)

• Terminal elimination rate constant (λz) of melatonin

  Up to 12 hours post dose in each period (3 periods)

Study Arms (1)

study drug

EXPERIMENTAL

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.

Drug: NPC-15 and/or Placebo

Interventions

NPC-15 and/or Placebo 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)

Also known as: Melatonin and/or Placebo

study drug

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nobelpharma: lead

Study Sites (1)

SOUSEIKAI Hakata Clinic

Fukuoka, 8120025, Japan

Location

Study Officials

• Masaharu Hayashi, MD, PhD

  Shukutoku University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This study is a single-arm, open label, dose escalation study. QT interval will be evaluated by blinding outcome assessor in this study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 23, 2018
• Study Start: April 3, 2018
• Primary Completion: April 29, 2018
• Study Completion: April 29, 2018
• Last Updated: June 28, 2018

Record last verified: 2018-04

Locations

JP (1)