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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05286281 | A Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance and Metabolism of PF-07265803 | PHASE1 | COMPLETED | 6 | — | — | Mar 31, 2022 | May 26, 2022 | Mar 29, 2024 | 1 | United States |
Radioactivity excreted in urine was reported as the percentage of the administered radioactivity excreted at each time interval, cumulatively through that interval and the total percent of dose recovered in urine.
Radioactivity excreted in feces was reported as the percentage of the administered radioactivity excreted at each time interval, cumulatively through that interval and the total percent of dose recovered in feces.
Radioactivity excreted in urine and feces was reported as the percentage of the administered radioactivity excreted at each time interval, cumulatively through that interval and the total percent of dose recovered in urine and feces.
Plasma homogenates were extracted for total radioactivity, and processed samples were analyzed by HPLC with radiochemical detection for quantitation of \[14C\]PF-07265803-derived components and by HRMS for identification of PF-07265803 and metabolites after a single 400-mg (100 μCi) oral dose of \[14C\]PF-07265803. Relative abundance of the metabolites of \[14C\]PF-07265803 in plasma based on \[14C\] quantitation was reported, expressed as percentage of radioactivity. PF-07265803 and four metabolites identified/characterized in human plasma including PF-07327859, PF-07327890, PF -07327860, and des(dimethylamino)-dioxy-PF-07265803 (m/z 461) were presented below. The plasma analysis was done with a single master pool sample (individual participants pooled based on time and from these a single master pool of all participants in one tube) due to the low amount of radioactivity in the plasma, hence there would be no mean or standard deviation.
Urine homogenates were extracted for total radioactivity, and processed samples were analyzed by HPLC with radiochemical detection for quantitation of \[14C\]PF-07265803-derived components and by HRMS for identification of PF-07265803 and metabolites after a single 400-mg (100 μCi) oral dose of \[14C\]PF-07265803. In this outcome measure, relative abundance of the metabolites of \[14C\]PF-07265803 in urine based on \[14C\] quantitation was reported, expressed as percentage of radioactivity. PF-07265803 and four metabolites identified/characterized in human urine including PF-07327859, PF-07327890, PF-07327891, and des(dimethylamino)-dioxy-PF-07265803 (m/z 461) were presented below.
Fecal homogenates were extracted for total radioactivity, and processed samples were analyzed by HPLC with radiochemical detection for quantitation of \[14C\]PF-07265803-derived components and by HRMS for identification of PF-07265803 and metabolites after a single 400-mg (100 μCi) oral dose of \[14C\]PF-07265803. In this outcome measure, relative abundance of the metabolites of \[14C\]PF-07265803 in feces based on \[14C\] quantitation was reported, expressed as percentage of radioactivity. PF-07265803 and four metabolites identified/characterized in human urine including PF-07327859, PF-07327890, PF-07327891, and PF-07327860 were presented below.
| Arm | Type | Description |
|---|---|---|
| PF-07265803 | EXPERIMENTAL | PF-07265803 is a p38 inhibitor formulated for oral delivery. |
| Name | Type | Description |
|---|---|---|
| PF-07265803 | DRUG | PF-07265803 is a p38 inhibitor formulated for oral delivery. |
Inclusion Criteria: 1. Participants must be male and ≥18 years of age at the time of signing the informed consent. 2. Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG) monitori...