MedDataX Logo

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

NCT ID: NCT02515864

Last Updated: 2017-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Moxifloxacin_QT Study in Chinese Healthy Volunteer

NCT01653990

QT Interval Prolongation
UNKNOWN NA

Race Difference Moxifloxacin-induced QT Prolongation Between Healthy Chinese and Caucasian Volunteers

NCT02119091

Cardiac Toxicity
UNKNOWN PHASE1

A Study Study to Investigate the Effect on QT/QTc Interval of Moxifloxacin After a Single Dose in Healthy Male Subjects

NCT01756521

the Effect of Moxifloxacin on QT/QTc Interval
COMPLETED PHASE1

A Study to Evaluate the Effects of KP-001 on the QT/QTc Intervals in Healthy Adults

NCT06649942

Healthy Volunteers - Male and Female
COMPLETED PHASE1

A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers

NCT01107054

Pulmonary Disease Lung Disease Moxifloxacin
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FYU-981 anticipated therapeutic dose

Drug: FYU-981, FYU-981 Placebo, Moxifloxacin Placebo (Oral)

Group Type EXPERIMENTAL

FYU-981

Intervention Type DRUG

Placebo

Intervention Type DRUG

Moxifloxacin Placebo

Intervention Type DRUG

FYU-981 supratherapeutic dose

Drug: FYU-981, Moxifloxacin Placebo (Oral)

Group Type EXPERIMENTAL

FYU-981

Intervention Type DRUG

Moxifloxacin Placebo

Intervention Type DRUG

Placebo

Drug: FYU-981 Placebo, Moxifloxacin Placebo (Oral)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Moxifloxacin Placebo

Intervention Type DRUG

Moxifloxacin

Drug: Moxifloxacin, FYU-981 Placebo (Oral)

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Moxifloxacin

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FYU-981

Intervention Type DRUG

Placebo

Intervention Type DRUG

Moxifloxacin

Intervention Type DRUG

Moxifloxacin Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fuji Yakuhin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Japan, Kanagawa, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FYU-981-007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects
NCT01140425 COMPLETED PHASE1
Phase I Study of OPC-61815
NCT03510663 COMPLETED PHASE1
Study to Investigate the Effect of KUC 7483 CL on the QT/QTc Interval of the ECG in Comparison to Placebo and Moxifloxacin in Healthy Male and Female Volunteers
NCT02256735 COMPLETED PHASE1
Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation
NCT01014247 COMPLETED PHASE1
A QT/QTc Evaluation Study of TS-142 in Healthy Adult Subjects
NCT04873323 COMPLETED PHASE1
Study Developed to Evaluate the Effect of ANG-3777 on QT/QTc Interval
NCT04898907 UNKNOWN PHASE1
A QT/QTc Evaluation Study of TS-172 in Healthy Adult Subjects
NCT06837155 COMPLETED PHASE1
A Study to Evaluate the Effects of JNJ-54861911 on Electrocardiogram Intervals in Healthy Particiants
NCT02152332 COMPLETED PHASE1
TMC207TBC1003 - A Study in Healthy Volunteers Investigating the Effect of Single-dose TMC207 on the QT/QTc Interval Under Fed Conditions
NCT01291563 COMPLETED PHASE1
Placebo and Moxifloxacin Controlled Cardiac Conduction Study of GSK2140944 in Healthy Volunteers
NCT02257398 COMPLETED PHASE1
Determining Highest Dose Administration of TC-5214 and Evaluating Effect on the Electrical Activity in the Heart
NCT01359618 TERMINATED PHASE1
Evaluate Effects of Meropenem-Vaborbactam on QT/QTc in Healthy Volunteers
NCT03564158 COMPLETED PHASE1
Phase I Study to Evaluate the Effect of GFT505 on QT/QTc Interval in Healthy Volunteers
NCT02091310 COMPLETED PHASE1
A Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female Subjects
NCT01173536 COMPLETED PHASE1
Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers
NCT03985410 COMPLETED PHASE1
Effect of PA-824 and of PA-824 Plus Moxifloxacin on the QTc Interval in Healthy Volunteers
NCT01674218 COMPLETED PHASE1
A Thorough QT Study of Telotristat Etiprate
NCT02155205 COMPLETED PHASE1
A Study of LY2484595 on the Electrical Activity of the Heart
NCT01537887 COMPLETED PHASE1
A Study to Evaluate the Effect of ACP-196 on the Heart Rate-corrected QT Interval in Healthy Adult Participants
NCT04867980 COMPLETED PHASE1
A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects
NCT01297062 COMPLETED PHASE1
Thorough QT/QTc of Pritelivir in Healthy Subjects
NCT05671029 COMPLETED PHASE1
A Single-Dose, Randomized, Placebo- and Active-Control, Four-Way, Cross-Over Study for the Evaluation of the Effect of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) on the QT/QTc Intervals in Adult Healthy Subjects
NCT04238195 COMPLETED PHASE1
A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers
NCT05192369 COMPLETED PHASE1
A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of Ceftazidime NXL104 or Ceftaroline Fosamil NXL104, Compared With Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers
NCT01290900 COMPLETED PHASE1
Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval
NCT05924815 COMPLETED PHASE1