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This study has been designed to investigate the effect of lersivirine on the QT/QTc interval in order to help establish the safety profile of lersivirine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Lersivirine Tolerability |
|
| Part B | Experimental | Thorough QTc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lersivirine | Drug | Lersivirine 2400 mg single dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| (Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects. | 1 day | |
| (Part B) To demonstrate a lack of effect of lersivirine on QTc relative to time-matched placebo. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| To determine study sensitivity by comparing the effect of moxifloxacin on QTc relative to time-matched placebo, at the historical moxifloxacin Tmax of 3 hours. | 1 day | |
| To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects. |
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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 |
|---|---|
| C531151 | UK 453,061 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
Placebo single dose |
|
| Lersivirine (if necessary) | Drug | Lersivirine 2100 mg single dose (if necessary) |
|
| Lersivirine | Drug | Lersivirine 2400 mg single dose (dose may be decreased pending Part A tolerability results) |
|
| Placebo | Drug | Placebo single dose |
|
| Moxifloxacin | Drug | Moxifloxacin 400 mg single dose |
|
| 1 day |
| To characterize the exposure-response relationship between lersivirine and changes in QTc using plasma concentrations of lersivirine. | 1 day |
| To assess the single dose pharmacokinetics of lersivirine. | 1 - 2 days |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |