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The objective of this study is to evaluate the effect of repeat oral dosing of mirabegron on ECG (electrocardiogram) measurements.
Each subject will be randomized and participate in two 10-day treatment periods during which once daily dosing of mirabegron and mirabegron/moxifloxacin placebo or moxifloxacin and moxifloxacin/mirabegron placebo will occur followed by a 1-day post-treatment period. Each treatment period will be separated by a washout period of at least 12 days from the last dose of study drug on Day 10 of Period 1 to Day -4 of Period 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| mirabegron high dose | Experimental |
| |
| mirabegron medium dose | Experimental |
| |
| mirabegron low dose | Experimental |
| |
| moxifloxacin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | oral |
| |
| mirabegron |
| Measure | Description | Time Frame |
|---|---|---|
| QTcl evaluated through electrocardiogram analysis | QTcI is a QT interval corrected for heart rate using individual-specific correction formula | Day 1 to Day 11 in Treatment Period 1 and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic assessment through electrocardiogram analysis | Day 1 to Day 11 in Treatment Period 1 and 2 |
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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 |
|---|---|---|---|---|---|---|
| Glendale | California | 91206 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23149929 | Background | Malik M, van Gelderen EM, Lee JH, Kowalski DL, Yen M, Goldwater R, Mujais SK, Schaddelee MP, de Koning P, Kaibara A, Moy SS, Keirns JJ. Proarrhythmic safety of repeat doses of mirabegron in healthy subjects: a randomized, double-blind, placebo-, and active-controlled thorough QT study. Clin Pharmacol Ther. 2012 Dec;92(6):696-706. doi: 10.1038/clpt.2012.181. Epub 2012 Nov 14. |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
oral |
|
|
| moxifloxacin | Drug | oral |
|
|
| Baltimore |
| Maryland |
| 21225 |
| United States |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |