Trials Sponsors Conditions Drugs Pricing

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)
+5 more secondary outcomes

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 PlaceboDrug

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

Nobelpharma
Industrylead

Study Sites (1)

SOUSEIKAI Hakata Clinic

Fukuoka, 8120025, Japan

Study Officials

Masaharu Hayashi, MD, PhD
Shukutoku University
PRINCIPAL INVESTIGATOR

Enrollment

12 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (1)

study drug

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (1)

study drug

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations