Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ViiV Healthcare | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate the safety and toleration of 2 different doses of lersivirine administered either fed or fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be evaluated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lersivirine 500 mg QD fasted (wet granulated tablet) | Experimental |
| |
| Lersivirine 500 mg QD fed (wet granulated tablet) | Experimental |
| |
| Lersivirine 750 mg QD fasted (wet granulated tablet) | Experimental |
| |
| Lersivirine 750 mg QD fed (wet granulated tablet) | Experimental |
| |
| Lersivirine 500 mg QD fasted (dry granulated tablet) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lersivirine | Drug | Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability of multiple doses of lersivirine administered to healthy subjects over 21 days. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7 | 21 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| C531151 | UK 453,061 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lersivirine | Drug | Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days |
|
| Lersivirine | Drug | Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days |
|
| Lersivirine | Drug | Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days |
|
| Lersivirine | Drug | Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days |
|
| Brussels |
| B-1070 |
| Belgium |