Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06412562 tablets_Fasted · 1 trial · 1 indication
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0 - t) plus AUC (t - inf).
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 3 mg PF-06412562 MR tablets_Fasted | DRUG | A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast |
| 2 x 15 mg PF-06412562 MR tablets_Fasted | DRUG | Two 15 mg PF-06412562 modified release tablets administered after an overnight fast |
| 2 x 15 mg PF-06412562 MR tablets_Fed | DRUG | Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast |
| 10 mg PF-06412562 IR tablets | DRUG | a single immediate release tablet of 10 mg PF-06412562 after an overnight fast |
Inclusion Criteria: * Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse ...
PF-06412562 tablets_Fasted refers to a modified release oral tablet formulation of PF-06412562 that was administered under fasted conditions in a Phase 1 clinical trial. The trial evaluated blood concentrations of the drug after oral dosing in healthy adult volunteers.
Pfizer, Inc. is the developer of PF-06412562. The company trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 trial of the modified release tablet formulation administered under fasted and fed conditions.
PF-06412562 is in Phase 1 clinical development. The single recorded trial of the modified release tablet formulation was a Phase 1 study that has been completed. The drug is investigational and is not approved for any indication.
PF-06412562 tablets_Fasted was studied in trial NCT02201511, titled a healthy volunteer trial to gain information about blood concentrations of PF-06412562 after oral administration of a modified release formulation in fasted and fed conditions. The Phase 1 trial enrolled 12 participants in Belgium and is completed.
The trial NCT02201511 was a Phase 1 controlled study of PF-06412562 modified release tablets in fasted and fed conditions. It enrolled 12 healthy volunteers of all sexes, aged 18 years and older, in Belgium. The study was randomized but not double blind, and it is completed.