Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lersivirine Immediate-Release · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Lersivirine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Lersivirine Immediate-Release (fasted) | DRUG | Single 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg) |
| 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. |
Inclusion Criteria: * 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: * History of regular alcohol consump...
Lersivirine Immediate-Release is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE). It is a Phase 1 study drug that has been evaluated in healthy adult volunteers. Its therapeutic indication has not been disclosed, and it remains in clinical development rather than being an approved medicine.
Lersivirine Immediate-Release is made and developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical study of this formulation in healthy volunteers.
Lersivirine Immediate-Release is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials of this formulation are currently active.
Lersivirine Immediate-Release has been studied in one completed Phase 1 trial, NCT01603485, titled a study to estimate the pharmacokinetics, bioavailability and effect of food on single dose modified-release lersivirine 500 mg in healthy subjects. The trial enrolled 16 healthy volunteers in Belgium and was uncontrolled, without randomization or double blinding.
Yes. Lersivirine Immediate-Release is also known as Lersivirine Immediate-Release (fasted). The fasted label refers to the dosing condition under which the immediate-release formulation was assessed, including the food-effect evaluation in the completed Phase 1 study NCT01603485.