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

NCT02515864 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-09-08

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

FYU-981

DRUG

Placebo

DRUG

Moxifloxacin

DRUG

Moxifloxacin Placebo

Sponsors & Collaborators

  • Fuji Yakuhin Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-03-31
Completion
2016-11-30

Countries

  • Japan

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515864 on ClinicalTrials.gov