Clinical Pharmacology of FYU-981 (Effect on QT/QTc Interval)

September 7, 2017 updated by: Fuji Yakuhin Co., Ltd.

A Crossover Study to Assess the Effects of FYU-981 on the QT/QTc Interval in Healthy Male and Female Volunteers

A Placebo-controlled, Four Way Crossover Study to Investigate the Effect on QT/QTc Interval of a Single Dose of FYU-981, Compared with Placebo, Using Moxifloxacin as a Positive Control, in Healthy Male and Female Volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • Japan, Kanagawa, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Japanese adult subjects
  • Body mass index: >=18.5 and <27.5

Exclusion Criteria:

  • Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FYU-981 anticipated therapeutic dose
Drug: FYU-981, FYU-981 Placebo, Moxifloxacin Placebo (Oral)
Drug: Placebo
Drug: FYU-981
Drug: Moxifloxacin Placebo
Experimental: FYU-981 supratherapeutic dose
Drug: FYU-981, Moxifloxacin Placebo (Oral)
Drug: FYU-981
Drug: Moxifloxacin Placebo
Placebo Comparator: Placebo
Drug: FYU-981 Placebo, Moxifloxacin Placebo (Oral)
Drug: Placebo
Drug: Moxifloxacin Placebo
Active Comparator: Moxifloxacin
Drug: Moxifloxacin, FYU-981 Placebo (Oral)
Drug: Placebo
Drug: Moxifloxacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
QT/QTc Interval
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuji Yakuhin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

August 2, 2015

First Posted (Estimate)

August 5, 2015

Study Record Updates

Last Update Posted (Actual)

September 8, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FYU-981-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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