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This study evaluates whether YM443 causes any changes in the electrocardiogram of healthy adults.
Each subject participates in all four treatment periods separated by washout periods.
In order to maintain the blind between arms, all subjects will receive the same number of tablets per day in each period of either active drug or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A. Placebo | Placebo Comparator |
| |
| B. Ym443 Lower Dose | Experimental |
| |
| C. YM443 Higher Dose | Experimental |
| |
| D. Moxiflocxacin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM443 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in the QTcF (Fridericia's correction) between each active treatment and placebo | Following four days of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change of the QTcI (Individual correction) and QTcB (Bazett's correction) between each active treatment and placebo. | Following four days of dosing | |
| The pharmacokinetics of YM443 in these subjects | Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tacoma | Washington | 98418 | United States |
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| ID | Term |
|---|---|
| C410959 | Z 338 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo | Drug | Oral |
|
| Moxifloxacin | Drug | Oral |
|
|
| The safety and tolerability of YM443 | Following four days of dosing |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |