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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02515864

Enrollment

Registered

2015-08-05

Start date

2015-08-31

Completion date

2016-11-30

Last updated

2017-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Male and Female Volunteers

Brief 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.

Interventions

DRUGFYU-981

DRUGPlacebo

DRUGMoxifloxacin

DRUGMoxifloxacin Placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
QT/QTc Interval	24 hours

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026