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

Sponsor

Fuji Yakuhin Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02515864

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: FYU-981 Drug: Placebo Drug: Moxifloxacin Drug: Moxifloxacin Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FYU-981 anticipated therapeutic dose Drug: FYU-981, FYU-981 Placebo, Moxifloxacin Placebo (Oral)	Drug: FYU-981 Drug: Placebo 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

Outcome Measures

Primary Outcome Measures

QT/QTc Interval [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Japan	Kanagawa	Japan

Sponsors and Collaborators

Fuji Yakuhin Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fuji Yakuhin Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02515864

Other Study ID Numbers:

FYU-981-007

First Posted:

Aug 5, 2015

Last Update Posted:

Sep 8, 2017

Last Verified:

Sep 1, 2017

Keywords provided by Fuji Yakuhin Co., Ltd.

Male and Female Volunteers

Additional relevant MeSH terms:

Moxifloxacin

Dotinurad

Norgestimate, ethinyl estradiol drug combination

Study Results

No Results Posted as of Sep 8, 2017