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| Name | Class |
|---|---|
| Theravance Biopharma | INDUSTRY |
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The purpose of this study is to evaluate if TD-4208, an investigational drug being developed to treat people with chronic obstructive pulmonary disease (COPD), has any effect on the electrical activity of the heart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-4208 175 mcg | Experimental | double-blind |
|
| TD-4208 700 mcg | Experimental | double-blind |
|
| Placebo for TD-4208 | Placebo Comparator | double-blind |
|
| Moxifloxacin 400 mg | Active Comparator | open-label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-4208 175 mcg | Drug | via nebulizer |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change-from-baseline in corrected QT | Predose to 24 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration Cmax | Predose to 24 hours postdose | |
| Adverse Events | Predose to 24 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Theravance Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| C583570 | revefenacin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| TD-4208 700 mcg | Drug | via nebulizer |
|
|
| Placebo for TD-4208 | Drug | via nebulizer |
|
| Moxifloxacin 400 mg | Drug | oral |
|
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |