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PF-07054894 · 2 trials · 1 indication
To characterize the rate and extent of excretion of total radioactivity following administration of a single oral dose of \[14C\]PF-07054894(Period 1 of Cohort 1 \& 2).
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Number of subjects with change from baseline of blood pressure, pulse rate, and oral temperature
| Arm | Type | Description |
|---|---|---|
| Cohort 1 Period 1 and Period 2 | EXPERIMENTAL | Period 1: This is designed to evaluate the metabolic fate and extent of excretion of PF-07054894 following the study drug administration via the intended clinical route of administration (oral) of \[cyclobutenyl-14C\]PF-07054894. In order to assess the metabolic fate of \[14C\]PF-07054894, metabolites of \[14C\]PF-07054894 circulating in plasma and eliminated in urine and feces following oral administration. Period 2: This is designed to evaluate oral bioavailability of a drug and also allow to estimate the fraction of the dose absorbed of the oral PF-07054894 dose. Determination of the fraction of the dose absorbed will provide information on the total PF-07054894 dose absorbed, regardless of the fate of that dose after absorption (eg, metabolism, degradation). |
| Cohort 2 Period 1 | EXPERIMENTAL | This is designed to further evaluate the cleavage of PF-07054894, which was identified in plasma samples from a preliminary investigation of metabolism in the FIH study. The metabolic fate and extent of excretion of PF-07054894 following the study drug administration via the intended clinical route of administration (oral) of - \[methyl-14C\]PF-07054894 will be evaluated. |
| PF-07054894 | EXPERIMENTAL | Participants will receive single or multiple ascending doses of oral PF-07054894 |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo |
| Name | Type | Description |
|---|---|---|
| PF-07054894 | DRUG | Cohort 1 Period 1 - Oral \[cyclobutenyl-14C\]PF-07054894 under fasted state. Cohort 1 Period 2: Oral unlabeled PF-07054894 followed by IV \[cyclobutenyl-14C\]PF-07054894 fusion over approximately 15 minutes at approximately 1.5 hours after the administration of the oral unlabeled dose. Cohort 1 Period 2: Oral unlabeled PF-07054894 followed by IV \[cyclobutenyl-14C\]PF-07054894 fusion over approximately 15 minutes at approximately 1.5 hours after the administration of the oral unlabeled dose. |
| Placebo | DRUG | Participants will receive matching placebo |
1. Healthy male, aged 18 years to 65 years at screening. 2. Body mass index (BMI) of about 18 to 32 kilogram per meter squared, and a total body weight greater than 50 kilograms (110 pounds). 3. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle conside...
PF-07054894 is an investigational small molecule being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development and has been studied in healthy adult participants. Two Phase 1 trials have been completed, with a total enrollment of 94 participants.
PF-07054894 is being studied for use in healthy participants, meaning it is not yet indicated for any specific disease or condition. It is in early-stage clinical development, and its potential therapeutic applications have not been established.
PF-07054894 is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the safety and processing of this investigational small molecule.
PF-07054894 is in Phase 1 clinical development. It is an investigational drug, meaning it is not approved by regulatory authorities and is still being studied in clinical trials. Two Phase 1 studies have been completed, but the drug remains in early-stage development.
PF-07054894 has been studied in two completed Phase 1 clinical trials. NCT04388878 evaluated single and multiple ascending doses in 84 healthy adults in Belgium. NCT07009353 studied how the radiolabeled form [14C]PF-07054894 is processed by the body in 10 healthy males in the Netherlands.
PF-07054894 and [14C]PF-07054894 are related but not identical. [14C]PF-07054894 is a radiolabeled version of PF-07054894 used in a clinical trial to track how the drug is absorbed, distributed, metabolized, and excreted by the body. The radiolabeled form is used for research purposes only.