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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07127770 | A Study to Understand How the Body Processes [14C]PF-07104091 in Healthy Participants | PHASE1 | COMPLETED | 9 | — | — | Aug 28, 2025 | Nov 7, 2025 | Dec 19, 2025 | 1 | Netherlands |
Percentage of 14C excreted in urine following 14C PF-07104091 single dose administration will be determined as: (Total 14C urine/ 14C dose administered) \*100 where, 14C dose was administered dose of 14C PF-07104091.
Percentage of 14C excreted in feces following 14C PF-07104091 single dose administration will be determined as: (Total 14C feces/ 14C dose administered) \*100 where, 14C dose was administered dose of 14C PF-07104091.
Percentage of 14C excreted in vomitus (if applicable) following 14C PF-07104091 single dose administration will be determined as: (Total 14C vomitus/ 14C dose administered) \*100 where, 14C dose was administered dose of 14C PF-07104091.
Percentage recovery of total radioactivity (14C) in urine, feces, and vomitus (If applicable) was determined based on total administered dose.
The percentage of major metabolites detected in plasma after oral administration of PF-07104091
The percentage of major metabolites detected in urine after oral administration of PF-07104091
The percentage of major metabolites detected in feces after oral administration of PF-07104091
| Arm | Type | Description |
|---|---|---|
| Regimen A; Period 1 | EXPERIMENTAL | Single oral dose of 14C-labeled PF-07104091 administered under fed conditions. |
| Regimen B; Period 2 | EXPERIMENTAL | Single oral dose of unlabeled PF-07104091 administered under fed conditions followed by an intravenous (IV) infusion of PF-07104091 containing a microdose of 14C-labeled PF-07104091. |
| Name | Type | Description |
|---|---|---|
| PF-07104091 | DRUG | Cyclin-dependent kinase-2 inhibitor |
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12-lead ECGs. * Body mass index (BMI) of 17.5-32.0 kg/m2 inclusive and a total body weight \>50 kg (110 lb) * Evidence of a personal...