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. (NYSE: PFE). It is in Phase 1 clinical development. The specific indication has not been disclosed, and the compound is classified in the therapeutic area of Other. It is not approved for any use.
PF-07265803 targets LMNA, a protein. LMNA encodes lamin A and lamin C, which are components of the nuclear lamina. By targeting LMNA, the drug is designed to interact with this protein, though the precise mechanism of action and the therapeutic rationale have not been publicly detailed.
PF-07265803 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sole sponsor of the clinical program for this asset.
PF-07265803 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 program includes one completed trial.
PF-07265803 has been studied in one Phase 1 trial, NCT05286281, titled A Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance and Metabolism of PF-07265803. The trial was completed, enrolled 6 healthy male volunteers, was uncontrolled, and was conducted in the United States.