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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04495140 | Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961 | PHASE1 | COMPLETED | 6 | — | — | Jul 22, 2020 | Oct 15, 2020 | Nov 25, 2020 | 2 | Netherlands |
Total recovery of radioactivity in urine and feces, and both routes combined, expressed as a percent of total oral radioactive dose administered.
| Arm | Type | Description |
|---|---|---|
| Oral [14C]PF-06882961, 50 mg | EXPERIMENTAL | In this arm, a single oral dose of \[14C\]PF-06882961, 50 mg will be administered as a liquid formulation. |
| Oral PF-06882961 50 mg and intravenous [14C]PF-06882961 100 ug | EXPERIMENTAL | In this arm, single oral dose of unlabeled PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of \[14C\]PF-06882961, 100 ug, will be administered via intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| [14C]PF-06882961, 50 mg | DRUG | A single oral dose of \[14C\]PF-06882961, will be administered as a liquid formulation. |
| PF-06882961, 50 mg and [14C]PF-06882961, 100 ug | DRUG | A single, oral, unlabeled dose of PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of \[14C\]PF-06882961 will be administered via intravenous infusion. |
Inclusion Criteria: * Male participants between 18 to 54 years of age * Healthy and capable of signing informed consent document * Willing to comply to all scheduled visits, lab tests, lifestyle considerations and study procedures * Body mass index (BMI) of 17.5 to 30 kg/m2; and a total body weight...