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OpenTrials
Completed

NCT Number: NCT02515864

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

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.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Japan, Kanagawa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FYU-981

Drug

Placebo

Drug

moxifloxacin

Drug

Moxifloxacin Placebo

Drug

Primary outcomes

  1. QT/QTc Interval

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Fuji Yakuhin Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 5, 2015
Registry last updated
Sep 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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