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 being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to assess drug-drug interactions when taken with PF-06865571. The study also includes overweight adults or adults with obesity who are otherwise healthy.
PF-06882961 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.
PF-06882961 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed.
PF-06882961 has one completed Phase 1 clinical trial with the identifier NCT04839393. This study evaluated drug-drug interactions between PF-06882961 and PF-06865571 in healthy adult participants and overweight adults or adults with obesity who are otherwise healthy.
No, PF-06882961 and PF-06865571 are two different investigational drugs. They were studied together in a Phase 1 clinical trial to evaluate potential drug-drug interactions between them. The trial enrolled healthy volunteers and overweight or obese adults.