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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KW-6356 therapeutic dose | Experimental | Oral administration |
|
| KW-6356 supratherapeutic dose | Experimental | Oral administration |
|
| Placebo | Placebo Comparator | Oral administration |
|
| Moxifloxacin | Active Comparator | Oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KW-6356 | Drug | KW-6356 will be administered once daily as therapeutic at Day 1 through Day 7 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QTc interval [QTcF] (ΔQTcF) | Day 1 through Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in the HR | Day 1 through Day 7 | |
| Changes from baseline in the QTc interval [QTcF] | Day 1 through Day 7 | |
| Changes from baseline in the PR interval |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Co. LTA Sumida Hospital | Sumida-ku | Tokyo | Japan | |||
| Medical Co. LTA Fukuoka Mirai Hospital Clinical Research Center |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| KW-6356 | Drug | KW-6356 will be administered once daily as supratherapeutic dose at Day 1 through Day 7 |
|
| Placebo | Drug | Placebo will be administered once daily at Day 1 through Day 7 |
|
| Moxifloxacin | Drug | Placebo will be administered once daily at Day 1 through Day 6, followed by Moxifloxacin once daily at Day 7. |
|
| Day 1 through Day 7 |
| Changes from baseline in the QRS interval | Day 1 through Day 7 |
| Placebo-corrected ΔQTcF | Day 1 through Day 7 |
| Placebo-corrected ΔHR | Day 1 through Day 7 |
| Placebo-corrected ΔPR interval | Day 1 through Day 7 |
| Placebo-corrected ΔQRS interval | Day 1 through Day 7 |
| Outliers in terms of category for HR | Day 1 through Day 7 |
| Outliers in terms of category for QTc interval (QTcF) | Day 1 through Day 7 |
| Outliers in terms of category for PR interval | Day 1 through Day 7 |
| Outliers in terms of category for QRS interval | Day 1 through Day 7 |
| Frequency of morphological changes in T wave after administration of the investigational product | Day 1 through Day 7 |
| Frequency of morphological changes in U wave after administration of the investigational product | Day 1 through Day 7 |
| Incidence of treatment-emergent adverse events | Day 1 through Day 20 |
| Plasma concentrations of KW-6356 | Day 1 through Day 8, and Day 12 |
| Fukuoka |
| Japan |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |