Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02201511 | A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions | PHASE1 | COMPLETED | 12 | — | — | Sep 1, 2014 | Oct 1, 2014 | Nov 10, 2015 | 1 | Belgium |
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 ...