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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02110342 | A Study To Understand How Radiolabelled PF-04449913 Is Taken Up By The Body, Broken Down And Then Removed From The Body | PHASE1 | COMPLETED | 6 | — | — | May 1, 2014 | Jun 1, 2014 | Jul 22, 2014 | 1 | United States |
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).
AUC (0 - 8)= Area under the plasma radioactivity 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).
Total percentage of dosed radioactivity recovered in urine and feces
Total percentage of radioactivity in blood related to drug product
Measure of renal clearance (CLr), amount excreted unchanged in urine (Ae) and the fraction of dose excreted unchanged in urine (AE%)
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| [14C] PF-04449913 | DRUG | Single oral dose of 100 mg PF-04449913 + 100µCi of \[14C\] PF-04449913 |
Inclusion Criteria: * Healthy male subjects 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 rate measurement, 12-lead ECG and clinical l...