Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lersivirine · 4 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 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 |
| Lersivirine (new formulation) | EXPERIMENTAL | - |
| Lersivirine (old formulation) | ACTIVE_COMPARATOR | - |
| Part A | EXPERIMENTAL | Lersivirine Tolerability |
| Part B | EXPERIMENTAL | Thorough QTc |
| Name | Type | Description |
|---|---|---|
| Lersivirine | DRUG | Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days |
| Rifabutin | DRUG | 300 mg once daily for 10 days |
| 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; and a total body weight \>50 kg (110 lbs). * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria...
Lersivirine is an investigational small molecule being studied in healthy volunteers. It is being developed by Pfizer, Inc. and is currently in Phase 1 clinical development. The drug has been evaluated in four completed clinical trials with a total enrollment of 171 participants.
Lersivirine is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development and has been studied in healthy volunteers.
Lersivirine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has completed four Phase 1 clinical trials, all of which were conducted in healthy volunteers.
Lersivirine has been studied in four completed Phase 1 clinical trials: NCT00925535, a drug interaction study with rifabutin; NCT00936871, a study on QT intervals; NCT01050751, a bioavailability study; and NCT01230385, a safety and tolerability study. All trials enrolled healthy volunteers.
Yes, Lersivirine is also known as UK-453,061. The clinical trials for Lersivirine, including NCT00925535 and NCT00936871, reference UK-453,061 in their titles, confirming that these names refer to the same investigational drug.