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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01702506 | Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804) | PHASE1 | COMPLETED | 24 | — | — | Oct 1, 2012 | Jan 1, 2013 | Dec 18, 2013 | 1 | Belgium |
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). For dacomitinib and PF-05199265
For dacomitinib and PF-05199265
| Arm | Type | Description |
|---|---|---|
| Fasted | EXPERIMENTAL | Dacomitinib administered under fasted conditions |
| Fed | EXPERIMENTAL | Dacomitinib administered under fed conditions |
| Antacid | EXPERIMENTAL | Dacomitinib administered under antacid treatment |
| Name | Type | Description |
|---|---|---|
| dacomitinib fasted | DRUG | Overnight fasted subjects will receive a single 45 mg dose of dacomitinib |
| dacomitinib fed | DRUG | Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal |
| dacomitinib+antacid | DRUG | Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole |
Inclusion Criteria: * Healthy subjects including males between the ages of 18 and 55 years. Females of non childbearing potential . * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * An informed consent document signed and dated by the subject. Exclusion Cr...