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| Name | Class |
|---|---|
| ViiV Healthcare | INDUSTRY |
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The purpose of this study is to estimate the pharmacokinetics (PK) of 3 different modified-release formulations of lersivirine and compare it to the PK of the immediate-release tablet. The effect of food on the PK of one of the modified-release tablets will also be assess along with the safety and tolerability of each treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lersivirine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lersivirine Immediate-Release (fasted) | Drug | Single 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lersivirine Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose | |
| Lersivirine Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose | |
| Lersivirine Maximum Observed Plasma Concentration (Cmax) | T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Lersivirine Plasma Decay Half-Life (t1/2) | T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose | |
| Lersivirine Time to Reach Maximum Observed Plasma Concentration (Tmax) | T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose |
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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 | B-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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| Lersivirine Modified-Release #1 (fasted) | Drug | Single 500 mg dose of Lersivirine Modified-Release Tablet #1 |
|
| Lersivirine Modified-Release #2 (fasted) | Drug | Single 500 mg dose of Lersivirine Modified-Release Tablet #2 |
|
| Lersivirine Modified-Release #3 (fasted) | Drug | Single 500 mg dose of Lersivirine Modified-Release Tablet #3 |
|
| Lersivirine Modified-Release (fed) | Drug | Single 500 mg dose of Lersivirine Modified-Release Tablet dosed with food. |
|
| Lersivirine Observed Plasma Concentration at time 24hr (C24) | T = 24 hours post dose |
| Lersivirine Last Observed Plasma Concentration (Clast) | T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose |