Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-07054894 · 3 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).
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs.
Number of participants with change from baseline in vital signs including supine blood pressure and pulse rate
The maximum observed plasma concentration (Cmax) will be observed directly from data.
Tmax will be observed directly from data
AUCτ is summarized by dosing interval and day. Dosing interval is the interval τ between administration of doses of drug.
terminal elimination half-life will be calculated based on the measured data
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 | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 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. |
| PF-07054894 or placebo | DRUG | multiple oral doses of PF-07054894 for 14 days |
| 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 developed by Pfizer, Inc. (NYSE: PFE). It is in Phase 1 clinical development, and the specific disease or condition it is intended to treat has not been disclosed. All completed studies to date have enrolled healthy adult volunteers rather than patients.
PF-07054894 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer has sponsored all three Phase 1 trials of the compound, including studies conducted in the Netherlands and Belgium.
PF-07054894 is in Phase 1 clinical development. Three Phase 1 trials have been completed, and there are currently no active trials. The compound has not been approved by the FDA and remains investigational.
Three completed Phase 1 trials have studied PF-07054894: NCT04388878, a single and multiple ascending dose study in 84 healthy adults; NCT06327880, a study in six healthy participants of Japanese origin; and NCT07009353, a radiolabeled study in ten healthy male participants in the Netherlands.
Across the three completed Phase 1 trials, 100 participants were enrolled in total. NCT04388878 enrolled 84 healthy adults, NCT07009353 enrolled 10 healthy male participants, and NCT06327880 enrolled 6 healthy participants of Japanese origin. All studies used healthy volunteers.
Yes. The PF-07054894 Phase 1 program was randomized, double blind, and placebo controlled. The trials enrolled healthy adult volunteers aged 18 years and older, and all three studies have been completed.