A Through QT/QTc Study of KW-6356

September 16, 2020 updated by: Kyowa Kirin Co., Ltd.

A Through QT/QTc Study of KW-6356 in Japanese Healthy Adults

The purpose of this study is to evaluate the effects of multiple therapeutic and supratherapeutic doses of KW-6356 on the QT interval corrected for heart rate in Japanese healthy adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
        • Medical Co. LTA Fukuoka Mirai Hospital Clinical Research Center
    • Tokyo
      • Sumida-ku, Tokyo, Japan
        • Medical Co. LTA Sumida Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 54 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects having issued written consent to this study at their own discretion
  • Men or women aged 20 to 54 years at the time of informed consent
  • Subjects with BMI ≥18.5 and <25.0 at screening
  • In case of women of childbearing potential,* subjects who have agreed to use highly effective and appropriate contraceptive methods from the time of informed consent to 4 weeks after the last dose of the investigational product or the index drug. Women of childbearing potential must have a negative serum pregnancy test at screening
  • At screening and Day -2, subjects with resting pulse rate of ≥45 and <100 bpm, systolic blood pressure of ≥90 and <140 mmHg, and diastolic blood pressure of ≥40 and <90 mmHg when measured in the supine position
  • Subjects whose standard 12-lead ECG data obtained at screening and Day -2 meet the following criteria and show no clinically significant abnormalities as confirmed by the investigator or subinvestigator Normal sinus rhythm: HR of ≥45 and ≤100 bpm QTc interval (QTcF): ≤450 msec QRS interval: ≤120 msec (must be re-measured manually if exceeding 120 msec) PR interval: ≤220 msec
  • Subjects whose potassium, sodium, calcium, and magnesium levels at screening are within institutional normal limits

Exclusion Criteria:

  • Subjects with any current disease requiring treatment
  • Subjects having drug allergy or its history
  • Subjects having psychiatric disease or its history
  • Positive results for any of the following infection-related items examined at screening: hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, human T-lymphotropic virus (HTLV)-1 antibody, rapid plasma reagin (RPR) test, or Treponema pallidum (TP) antibody
  • Subjects being alcohol- or drug-dependent or having a positive result for any of the drug abuse test items
  • Subjects previously or concurrently having any of the following diseases or subjects with a family history of any of the following diseases:

Hypokalemia, hypocalcemia, and/or long QT syndrome Risk factors for torsade de pointes such as cardiac failure, cardiomyopathy, and a family history of long QT syndrome Sick sinus syndrome, second- or third-degree atrioventricular block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, QT interval prolongation, or atrioventricular conduction disturbance Repeated or frequent syncope or vasovagal attack Hypertension, angina pectoris, bradycardia, or severe peripheral arterial circulatory disorder

  • Subjects categorized as patients listed in the warnings or contraindications section of the package insert of moxifloxacin hydrochloride
  • Subjects unable to be compliant with Specified "Concomitant Medication and Concomitant Therapy" and "Instruction for Subjects"
  • Subjects having participated in a clinical study of a pharmaceutical product or a medical device or any equivalent study and used the investigational product or the unapproved medical device within 4 months prior to administration of the investigational product
  • Subjects having used any drug within 2 weeks prior to administration of the investigational product
  • Subjects having consumed grapefruit or any food or beverage containing St John's wort within 1 week prior to administration of the investigational product
  • Subjects having smoked or used smoking cessation agents within 4 weeks prior to administration of the investigational product
  • Subjects categorized as "yes" to "active suicidal ideation with some intent to act, without specific plan" or "active suicidal ideation with specific plan and intent" on the Columbia-Suicide Severity Rating Scale assessed on Day -2 or subjects with a history of or currently observed suicidal behavior
  • Subjects having undergone ≥400 mL of blood collection within 12 weeks prior to administration of the investigational product or ≥200 mL of blood collection within 4 weeks prior to administration of the investigational product for blood donation or in a clinical trial, etc. or subjects having undergone blood collection for pheresis donation within 2 weeks prior to administration of the investigational product
  • Subjects having issued no consent to adoption of any appropriate contraceptive method during the period from day of informed consent to 4 weeks after the final administration of the investigational product or the index drug for women of childbearing potential and during the period from start day of study treatment to 12 weeks after the final administration of the investigational product or the index drug for men of reproductive potential. The appropriate contraceptive method

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: KW-6356 therapeutic dose
Oral administration
Drug: KW-6356
KW-6356 will be administered once daily as therapeutic at Day 1 through Day 7
Drug: KW-6356
KW-6356 will be administered once daily as supratherapeutic dose at Day 1 through Day 7
EXPERIMENTAL: KW-6356 supratherapeutic dose
Oral administration
Drug: KW-6356
KW-6356 will be administered once daily as therapeutic at Day 1 through Day 7
Drug: KW-6356
KW-6356 will be administered once daily as supratherapeutic dose at Day 1 through Day 7
PLACEBO_COMPARATOR: Placebo
Oral administration
Drug: Placebo
Placebo will be administered once daily at Day 1 through Day 7
ACTIVE_COMPARATOR: Moxifloxacin
Oral administration
Drug: Moxifloxacin
Placebo will be administered once daily at Day 1 through Day 6, followed by Moxifloxacin once daily at Day 7.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in QTc interval [QTcF] (ΔQTcF)
Time Frame: Day 1 through Day 7
Day 1 through Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes from baseline in the HR
Time Frame: Day 1 through Day 7
Day 1 through Day 7
Changes from baseline in the QTc interval [QTcF]
Time Frame: Day 1 through Day 7
Day 1 through Day 7
Changes from baseline in the PR interval
Time Frame: Day 1 through Day 7
Day 1 through Day 7
Changes from baseline in the QRS interval
Time Frame: Day 1 through Day 7
Day 1 through Day 7
Placebo-corrected ΔQTcF
Time Frame: Day 1 through Day 7
Day 1 through Day 7
Placebo-corrected ΔHR
Time Frame: Day 1 through Day 7
Day 1 through Day 7
Placebo-corrected ΔPR interval
Time Frame: Day 1 through Day 7
Day 1 through Day 7
Placebo-corrected ΔQRS interval
Time Frame: Day 1 through Day 7
Day 1 through Day 7
Outliers in terms of category for HR
Time Frame: Day 1 through Day 7
Day 1 through Day 7
Outliers in terms of category for QTc interval (QTcF)
Time Frame: Day 1 through Day 7
Day 1 through Day 7
Outliers in terms of category for PR interval
Time Frame: Day 1 through Day 7
Day 1 through Day 7
Outliers in terms of category for QRS interval
Time Frame: Day 1 through Day 7
Day 1 through Day 7
Frequency of morphological changes in T wave after administration of the investigational product
Time Frame: Day 1 through Day 7
Day 1 through Day 7
Frequency of morphological changes in U wave after administration of the investigational product
Time Frame: Day 1 through Day 7
Day 1 through Day 7
Incidence of treatment-emergent adverse events
Time Frame: Day 1 through Day 20
Day 1 through Day 20
Plasma concentrations of KW-6356
Time Frame: Day 1 through Day 8, and Day 12
Day 1 through Day 8, and Day 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6356-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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