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A Through QT/QTc Study of KW-6356

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342273
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: KW-6356 Drug: Placebo Drug: Moxifloxacin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Through QT/QTc Study of KW-6356 in Japanese Healthy Adults
Actual Study Start Date : March 31, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: KW-6356 supratherapeutic dose
Oral administration
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.




Primary Outcome Measures :
  1. Change from baseline in QTc interval [QTcF] (ΔQTcF) [ Time Frame: Day 1 through Day 7 ]

Secondary Outcome Measures :
  1. Changes from baseline in the HR [ Time Frame: Day 1 through Day 7 ]
  2. Changes from baseline in the QTc interval [QTcF] [ Time Frame: Day 1 through Day 7 ]
  3. Changes from baseline in the PR interval [ Time Frame: Day 1 through Day 7 ]
  4. Changes from baseline in the QRS interval [ Time Frame: Day 1 through Day 7 ]
  5. Placebo-corrected ΔQTcF [ Time Frame: Day 1 through Day 7 ]
  6. Placebo-corrected ΔHR [ Time Frame: Day 1 through Day 7 ]
  7. Placebo-corrected ΔPR interval [ Time Frame: Day 1 through Day 7 ]
  8. Placebo-corrected ΔQRS interval [ Time Frame: Day 1 through Day 7 ]
  9. Outliers in terms of category for HR [ Time Frame: Day 1 through Day 7 ]
  10. Outliers in terms of category for QTc interval (QTcF) [ Time Frame: Day 1 through Day 7 ]
  11. Outliers in terms of category for PR interval [ Time Frame: Day 1 through Day 7 ]
  12. Outliers in terms of category for QRS interval [ Time Frame: Day 1 through Day 7 ]
  13. Frequency of morphological changes in T wave after administration of the investigational product [ Time Frame: Day 1 through Day 7 ]
  14. Frequency of morphological changes in U wave after administration of the investigational product [ Time Frame: Day 1 through Day 7 ]
  15. Incidence of treatment-emergent adverse events [ Time Frame: Day 1 through Day 20 ]
  16. Plasma concentrations of KW-6356 [ Time Frame: Day 1 through Day 8, and Day 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342273


Contacts
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Contact: Kyowa Kirin Co., Ltd. please contact us by email clinical.info.jp@kyowakirin.com

Locations
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Japan
Medical Co. LTA Sumida Hospital Recruiting
Sumida-ku, Tokyo, Japan
Medical Co. LTA Fukuoka Mirai Hospital Clinical Research Center Recruiting
Fukuoka, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT04342273    
Other Study ID Numbers: 6356-007
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Moxifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents