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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000103-47 | EudraCT Number | ||
| TQT | Other Identifier | Alias Study Number |
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The purpose of this study is to demonstrate a lack of effect of sertraline on QTc intervals relative to time-matched placebo in healthy subjects
Evaluate multiple doses of 400 mg per day of sertraline on QTc, and evaluate the safety and tolerability of sertraline in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertraline | Experimental | Maximum dose of 400 mg/day (200 mg BID given at approximately 12 hours apart) sertraline, dose titrated from a starting single dose (QD) of 50 mg in the morning on Day 1 followed by BID doses administered on Days 2 through 14 (Day 14 morning dose only) will be administered |
|
| Moxifloxacin | Active Comparator | 400 mg single dose of moxifloxacin (Avelox®) administered on Day 14 |
|
| Drug - Placebo | Placebo Comparator | placebo - placebo administered on Days 1 through 14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline | Drug | Multiple doses of sertraline for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postdose QTcF (Fridericia's correction) intervals | 0 to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Averse events, vital signs, physical examinations and abnormal laboratory for safety assessments (safety and tolerability) | Through study completion, an average of 3 months | |
| Relationship between QTc prolongation and measured sertraline/metabolite plasma concentrations |
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Inclusion Criteria:
Exclusion Criteria:
Risk factors for QT prolongation or torsades de pointes
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| D000095485 | Bulk Drugs |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| Moxifloxacin | Drug | A single dose of 400 mg Moxifloxacin |
|
|
| Drug - Placebo | Drug | Placebo administered for 14 days |
|
|
| 0 to 72 hours |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004364 | Pharmaceutical Preparations |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |