AzTrials
AzTrials

Parkinson's DiseasePhase 1NCT04342273

A Through QT/QTc Study of KW-6356

A Phase 1 study testing KW-6356 and Moxifloxacin in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 54 yearsHealthy volunteers can take part
Conditions the study is for
Parkinson's Disease
What is being tested?
KW-6356 and Moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
2 sitesJapan
Study dates
31 Mar 2020to 5 Sep 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 54 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 16Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Medical Co. LTA Fukuoka Mirai Hospital Clinical Research Center

    Fukuoka

  • Medical Co. LTA Sumida Hospital

    Sumida-ku, Tokyo

Other trials in Japan

About this study

Official title: 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.

Being tested
KW-6356, Placebo, Moxifloxacin
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KW-6356Drug

    KW-6356 will be administered once daily as therapeutic at Day 1 through Day 7

  • KW-6356Drug

    KW-6356 will be administered once daily as supratherapeutic dose at Day 1 through Day 7

  • PlaceboDrug

    Placebo will be administered once daily at Day 1 through Day 7

  • MoxifloxacinDrug

    Placebo will be administered once daily at Day 1 through Day 6, followed by Moxifloxacin once daily at Day 7.

Study groups in NCT04342273
Study groupRoleWhat they receive
KW-6356 therapeutic doseExperimentalOral administration
Receives: Drug: KW-6356
KW-6356 supratherapeutic doseExperimentalOral administration
Receives: Drug: KW-6356
PlaceboPlacebo comparatorOral administration
Receives: Drug: Placebo
MoxifloxacinActive comparatorOral administration
Receives: Drug: Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in QTc interval [QTcF] (ΔQTcF)

    Measured: Day 1 through Day 7

Secondary outcomes (16)

  1. Changes from baseline in the HR

    Measured: Day 1 through Day 7

  2. Changes from baseline in the QTc interval [QTcF]

    Measured: Day 1 through Day 7

  3. Changes from baseline in the PR interval

    Measured: Day 1 through Day 7

  4. Changes from baseline in the QRS interval

    Measured: Day 1 through Day 7

  5. Placebo-corrected ΔQTcF

    Measured: Day 1 through Day 7

  6. Placebo-corrected ΔHR

    Measured: Day 1 through Day 7

  7. Placebo-corrected ΔPR interval

    Measured: Day 1 through Day 7

  8. Placebo-corrected ΔQRS interval

    Measured: Day 1 through Day 7

  9. Outliers in terms of category for HR

    Measured: Day 1 through Day 7

  10. Outliers in terms of category for QTc interval (QTcF)

    Measured: Day 1 through Day 7

  11. Outliers in terms of category for PR interval

    Measured: Day 1 through Day 7

  12. Outliers in terms of category for QRS interval

    Measured: Day 1 through Day 7

  13. Frequency of morphological changes in T wave after administration of the investigational product

    Measured: Day 1 through Day 7

  14. Frequency of morphological changes in U wave after administration of the investigational product

    Measured: Day 1 through Day 7

  15. Incidence of treatment-emergent adverse events

    Measured: Day 1 through Day 20

  16. Plasma concentrations of KW-6356

    Measured: Day 1 through Day 8, and Day 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2020
  2. Study start31 Mar 2020
  3. Primary completion5 Sep 2020
  4. Study completion5 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04342273
Sponsor's protocol ID
6356-007
Status last verified
Sep 2020
First submitted
8 Apr 2020
Last updated
18 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KW-6356 and Moxifloxacin in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in QTc interval [QTcF] (ΔQTcF) (time frame: Day 1 through Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04342273.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in