Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-07265803 · 1 trial · 1 indication
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...
PF-07265803 is an investigational small molecule being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic area is categorized as Other. As of now, it is not approved and remains in clinical trials.
PF-07265803 is being studied for use in healthy volunteers, as part of early-phase clinical research. The drug is intended to evaluate its pharmacokinetics, excretion, mass balance, and metabolism. It is not yet approved for any specific medical condition, and its clinical development is in the Phase 1 stage.
PF-07265803 is developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule currently in Phase 1 clinical trials. Pfizer is conducting research to understand the drug's properties in healthy subjects.
PF-07265803 is in Phase 1 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is not yet available for clinical use. Further development stages have not been disclosed.
PF-07265803 has one completed clinical trial, identified as NCT05286281. This Phase 1 study evaluated the pharmacokinetics, excretion, mass balance, and metabolism of the drug in healthy male volunteers aged 18 years and older. The trial was conducted in the United States and enrolled 6 participants.
PF-07265803 is not known to be the same as any other drug, as no alternative names have been identified for this investigational compound. It is a distinct small molecule being developed by Pfizer, Inc. for research purposes. Its unique identifier is PF-07265803, and it is currently in Phase 1 trials.