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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07009353 | A Study to Learn How the Study Medicine Called [14C]PF-07054894 is Processed by the Body | PHASE1 | COMPLETED | 10 | — | — | Jun 20, 2025 | Sep 11, 2025 | Dec 2, 2025 | 1 | Netherlands |
| NCT04388878 | Study Of Single And Multiple Ascending Doses Of PF-07054894 In Healthy Adult Participants | PHASE1 | COMPLETED | 84 | — | — | Jul 27, 2020 | Jun 21, 2022 | Jul 12, 2022 | 1 | Belgium |
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...