Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PF-06865571 Immediate release suspension
PF-06865571 Immediate release · 2 trials · 2 indications
All study participants
All study participants
All study participants
All study participants
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).
Plasma Decay Half-Life (t1/2)
| Arm | Type | Description |
|---|---|---|
| Relative Bioavailability | EXPERIMENTAL | Each participant will receive 400 mg IR, 400 mg MR, and 50 mg MR in the fed state, and 400 mg MR in the fasted state |
| Fasted State | EXPERIMENTAL | Comparison of 400 mg MR in fed and fasted states |
| PF-06865571 | EXPERIMENTAL | Treatment |
| Name | Type | Description |
|---|---|---|
| PF-06865571 400 mg Immediate Release (IR) in Fed State | DRUG | 400 mg IR dose in fed state |
| PF-06865571 50 mg Modified Release (MR) in Fed State | DRUG | 50 mg MR in fed state |
| PF-06865571 400 mg MR in Fed State | DRUG | 400 mg MR in fed state |
| PF-06865571 400 mg MR in Fasted State | DRUG | 400 mg MR in fasted state |
| PF-06865571 Immediate release suspension | DRUG | Suspension |
| PF-06865571 Slow release MR tablets | DRUG | Modified release tablets |
| PF-06865571 Fast release MR tablets | DRUG | Modified release tablets |
| PF-06865571 Immediate release tablets | DRUG | Immediate release tablets |
Inclusion Criteria: * Female participants of non-childbearing potential and male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac tests. * Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total ...
PF-06865571 Immediate release is an investigational small molecule developed by Pfizer, Inc. (ticker: PFE). It is an immediate-release formulation of PF-06865571 that has been studied in Phase 1 clinical trials in healthy adult participants. The specific therapeutic indication for this drug candidate has not been disclosed.
PF-06865571 Immediate release is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer sponsored the Phase 1 clinical studies evaluating this immediate-release formulation of PF-06865571 in healthy adult volunteers.
PF-06865571 Immediate release is in Phase 1 clinical development. Both of its recorded trials have been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.
PF-06865571 Immediate release has been evaluated in two completed Phase 1 trials: NCT04044053, a relative bioavailability study of a modified-release formulation in healthy adults in Belgium, and NCT03372044, which evaluated different formulations in healthy subjects. Each trial enrolled 12 participants, for a total of 24.
PF-06865571 Immediate release is also known as PF-06865571 Immediate release suspension, PF-06865571 400 mg Immediate Release (IR) in Fed State, and PF-06865571 Immediate Release in Fed State. These names refer to the same investigational immediate-release formulation of PF-06865571 being studied by Pfizer.
The therapeutic indication for PF-06865571 Immediate release has not been disclosed. The drug has only been studied in Phase 1 trials in healthy adult volunteers, not in patients with a specific disease. Its clinical development to date has focused on formulation and bioavailability assessments rather than efficacy in a defined condition.