Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lersivirine · 6 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Abacavir/Lamivudine | ACTIVE_COMPARATOR | - |
| Lersivirine + Abacavir/Lamivudine | EXPERIMENTAL | - |
| 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 | - |
| Treatment A | ACTIVE_COMPARATOR | Lersivirine |
| Treatment B | ACTIVE_COMPARATOR | Rifabutin |
| Treatment C | EXPERIMENTAL | Lersivirine and Rifabutin |
| Methadone | ACTIVE_COMPARATOR | Dose of methadone must not change from 1 week prior to study start and through the duration of the study. |
| Lersivirine + Methadone | EXPERIMENTAL | - |
| Lersivirine (new formulation) | EXPERIMENTAL | - |
| Lersivirine (old formulation) | ACTIVE_COMPARATOR | - |
| Part A | EXPERIMENTAL | Lersivirine Tolerability |
| Part B | EXPERIMENTAL | Thorough QTc |
| Name | Type | Description |
|---|---|---|
| Abacavir/Lamivudine | DRUG | Abacavir/Lamivudine 600/300 mg QD for 5 days |
| Lersivirine | DRUG | Lersivirine 750 mg QD for 10 days |
| Rifabutin | DRUG | 300 mg once daily for 10 days |
| Methadone | DRUG | Methadone 50 - 150 mg QD (Day 1) |
| Lersivirine + Methadone | DRUG | Lersivirine 1000 mg QD + Methadone 50 - 150 mg QD (Days 2-11) |
| Placebo | DRUG | Placebo single dose |
| Lersivirine (if necessary) | DRUG | Lersivirine 2100 mg single dose (if necessary) |
| Moxifloxacin | DRUG | Moxifloxacin 400 mg single dose |
Inclusion Criteria: * Healthy male and/or female subjects. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2. * Total body weight \>50 kg (110 lbs). Exclusion Criteria: * History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL...
Lersivirine is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It has been studied in Phase 1 clinical trials, primarily in healthy volunteers, including studies of its safety, tolerability, and drug interaction profile. Its therapeutic indication has not been disclosed.
Lersivirine is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 1 clinical program for the compound, including studies conducted in the United States and Belgium.
Lersivirine is in Phase 1 clinical development. All six of its recorded trials are Phase 1 studies, and all six are completed, with no active trials currently listed. It is an investigational agent and is not described as approved.
Lersivirine has been evaluated in completed Phase 1 trials including NCT01230385, a 21-day multiple-dose safety and tolerability study in 75 healthy subjects, NCT01220232, which assessed its effect on abacavir/lamivudine pharmacokinetics, NCT01099748, which examined methadone pharmacokinetics, and NCT01050751, a bioavailability study of a 750 mg tablet versus three 250 mg tablets.
Across the recorded Lersivirine trials, total enrollment is 198 participants. The studies were randomized and active-controlled, with enrollment ranging from 12 to 75 healthy volunteers per trial. All six trials are completed, and none are currently active.