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

Fuji Yakuhin Co., Ltd.48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

FYU-981DRUG

PlaceboDRUG

MoxifloxacinDRUG

Moxifloxacin PlaceboDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Japan, Kanagawa, Japan

Outcomes

Primary Outcomes

QT/QTc Interval

Time frame: 24 hours

Data from ClinicalTrials.gov

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