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This Phase 1 study will assess the effects of esreboxetine on the heart. In particular the effects on a specific electrocardiogram (ECG) measurement called QTc will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One | Experimental |
| |
| Two | Placebo Comparator |
| |
| Three | Active Comparator | Administration of a single oral dse of 400mg moxifloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esreboxetine | Drug | Once daily administration of 4mg esreboxetine for 3 days, followed by 8mg esreboxetine for 3 days, followed by 10mg esreboxetine for 3 days. Drug will be administered double-blind. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To asses the the relationship between plasma concentrations of esreboxetine and its effects, if any on the QTc interval | Up to 24 hours | |
| To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers | Up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brussels | 1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| C541385 | esreboxetine |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| placebo | Drug | Once daily administration of placebo for 9 days. Placebo will be administered double blind |
|
| moxifloxacin | Drug | Once daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9 |
|
| D009422 |
| Nervous System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |