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| ID | Type | Description | Link |
|---|---|---|---|
| R09-0539 |
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| Name | Class |
|---|---|
| Cetero Research, San Antonio | NETWORK |
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The purpose of this study is to assess whether multiple doses of Talampanel increase the QT interval when compared to placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Talampanel | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Moxifloxacin | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talampanel | Drug | titrated to 50mg three times a day over 9 days and a single dose administered on Day 10 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effects of Talampanel on cardiac repolarization after multiple therapeutic doses administered over 10 days | 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Examine the PK profile of talampanel and its metabolite -Assess the PK/PD relationship of the time course of QT/QTc interval prolongation-Assess the safety and tolerability of multiple doses of talampanel in healthy volunteers | 12 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig R Sprenger, MD | Cetero Research - Fargo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cetero Research - Fargo | Fargo | North Dakota | 58104 | United States |
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| ID | Term |
|---|---|
| C085266 | talampanel |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin | Drug | Placebo administered three times a day over 9 days and a single dose of moxifloxacin administered on Day 10 |
|
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| Placebo | Drug | administered three times a day over 9 days and a single dose administered on Day 10 |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |