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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03770039 | Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects | PHASE1 | COMPLETED | 6 | — | — | Dec 10, 2018 | Feb 21, 2019 | Mar 6, 2019 | 2 | Netherlands |
cumulative recovery of radioactivity over time in urine, as percentage of total radioactive dose administered
cumulative recovery of radioactivity over time in feces, as percentage of total radioactive dose administered
| Arm | Type | Description |
|---|---|---|
| 2-period, fixed sequence | EXPERIMENTAL | fixed sequence with 2 treatment period |
| Name | Type | Description |
|---|---|---|
| Oral PF-06700841 containing 14C microtracer | DRUG | Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period |
| Oral unlabeled PF-06700841 | DRUG | 60 mg unlabeled PF-06700841 oral dose in 2nd period |
| IV 14C-labeled PF-06700841 | DRUG | 30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period |
Exclusion Criteria: * Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection). * Total 14C radioactivity measured in plasma exceeding 11 mBq/mL * History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON®-TB Gold test * Use of ...