Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06882961 followed by PF-06882961/PF-06865571 · 1 trial · 1 indication
Cmax for PF-06882961 was observed directly from data.
AUC24 for PF-06882961 was determined by Linear/Log trapezoidal method.
Cmax for PF-06865571 was observed directly from data on Day 1 and Day 47.
AUClast for PF-06865571 was determined by Linear/Log trapezoidal method on Day 1 and Day 47.
AUCinf for PF-06865571 was calculated as AUClast + (Clast\*/kel) on Day 1 and Day 47. Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the elimination rate constant.
Cmax for PF-06882961 was observed directly from data on Day 46 and Day 61.
AUC 12 for PF-06882961 was determined by Linear/Log trapezoidal method on Day 46 and Day 61.
| Arm | Type | Description |
|---|---|---|
| Part A - Sequence 1 | EXPERIMENTAL | Treatment A - PF-06882961 single dose followed by Treatment B - PF-06882961 single dose and PF-06865571 single dose |
| Part A - Sequence 2 | EXPERIMENTAL | Treatment B - PF-06882961 single dose and PF-06865571 single dose followed by Treatment A - PF-06882961 single dose |
| Part B | EXPERIMENTAL | Period 1: PF-06865571 single dose, Period 2: PF-06882961 twice daily dose titration, Period 3: PF-06865571 single dose and PF-06882961 twice daily dosing, Period 4: PF-06865571 twice daily dosing and PF-06882961 twice daily dosing |
| Name | Type | Description |
|---|---|---|
| PF-06882961 followed by PF-06882961/PF-06865571 | DRUG | Treatment A - PF-06882961 20 mg single dose followed by Treatment B - PF-06882961 20 mg single dose plus PF-06865571 300 mg single dose. There will be a washout interval between periods of at least 3 days. |
| PF-06882961/PF-06865571 followed by PF-06882961 | DRUG | Treatment B - PF-06882961 20 mg single dose plus PF-06865571 300 mg single dose followed by Treatment A - PF-06882961 20 mg single dose. There will be a washout interval between periods of at least 3 days. |
| PF-06882961 + PF-06865571 | DRUG | Period 1: PF-06865571 300 mg single dose (Day 1), Period 2: PF-06882961 10 mg twice daily dose titration up to 200 mg twice daily dosing (Days 3-46), Period 3: PF-06865571 300 mg single dose (Day 47) and PF-06882961 200 mg twice daily dosing (Days 47-48), Period 4: PF-06865571 300 mg twice daily dosing and PF-06882961 200 mg twice daily dosing (Days 49-62) |
Inclusion Criteria: 1. Male and female participants must be 18 to 65 years of age, inclusive, at the time of signing the ICD. Women can be of child-bearing potential, however, cannot be pregnant, breastfeeding, or planning to become pregnant while participating in the study. 2. Male and female ...
PF-06882961 is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE). It has been studied in a Phase 1 drug-drug interaction trial in healthy adult participants and overweight or obese adults who were otherwise healthy. The specific disease indications for PF-06882961 have not been disclosed.
PF-06882961 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 trial of PF-06882961 and the related combination with PF-06865571.
PF-06882961 is in Phase 1 clinical development. The only listed trial, NCT04839393, is a completed Phase 1 drug-drug interaction study. PF-06882961 is investigational and has not been approved by the FDA for any indication.
PF-06882961 has been evaluated in one completed Phase 1 trial, NCT04839393. The study was titled a drug-drug interaction study between PF-06882961 and PF-06865571 in healthy adult participants and overweight adults or adults with obesity who are otherwise healthy. It enrolled 27 participants in the United States.
No, PF-06882961 and PF-06865571 are distinct small molecules. They were co-administered in a Phase 1 drug-drug interaction study, NCT04839393, to evaluate how the two compounds interact when given together. PF-06882961 is also referred to in the context of the combination PF-06882961/PF-06865571.