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The objective of this study is to evaluate the effect of repeat oral dosing of ASP1941 on electrocardiogram (ECG) measurements.
Subjects will be randomized in four treatment sequences of twenty subjects each. Subjects in each treatment sequence will participate in a total of four treatment periods (A, B, C, and D) separated by washout periods of at least 7 days from completion of the prior period (Day 8) through clinical check-in (Day -1) of the next study period.
For Period 1, subjects will be admitted to the clinical research unit on Day -2. For each subsequent study period, subjects will be admitted to the clinical research unit on Day -1. Subjects will be discharged from the unit after completing procedures on Day 8 of each period. Subjects will receive a follow-up telephone call 7-10 days after their last clinic day (Period 4\Early Discontinuation [ED]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Placebo Comparator | Placebo |
|
| Treatment B | Experimental | ASP1941 low dose |
|
| Treatment C | Experimental | ASP1941 high dose |
|
| Treatment D | Active Comparator | Moxifloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral |
| |
| ASP1941 |
| Measure | Description | Time Frame |
|---|---|---|
| QTcF evaluated through electrocardiogram analysis (ECG) | QTcF is a QT interval corrected for heart rate (Fridericia's formula) | Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Electrocardiogram (ECG) | Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4) | |
| QTcI evaluated through electrocardiogram analysis | QTcI is a QT interval corrected for individual heart rate |
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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 |
|---|---|---|---|---|---|---|
| West Bend | Wisconsin | 53095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23910665 | Derived | Zhang W, Smulders R, Abeyratne A, Dietz A, Krauwinkel W, Kadokura T, Keirns J. Ipragliflozin does not prolong QTc interval in healthy male and female subjects: a phase I study. Clin Ther. 2013 Aug;35(8):1150-1161.e3. doi: 10.1016/j.clinthera.2013.06.009. Epub 2013 Aug 2. |
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| ID | Term |
|---|---|
| C572941 | ipragliflozin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
Oral |
|
| Moxifloxacin | Drug | Oral |
|
|
| Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4) |
| QTcB evaluated through electrocardiogram analysis (ECG) | QTcB is a QT interval corrected for heart rate (Bazett's formula) | Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4) |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |