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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519882-23-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to learn how quickly and to what extent the study medicine (PF-07054894) is absorbed, broken down, and eliminated from the body.
There are two groups in this study:
Participants in Cohort 1 will be involved in this study for about 10 weeks and about 8 weeks for those in Cohort 2. Participants in Cohort 1 will stay in the study clinic in Period 1 for up to 15 days (14 nights) and 8 days (7 nights) in Period 2. Participants in Cohort 2 will stay in the study clinic for up to 15 days (14 nights).
For Period 1 of both Cohort 1 and 2, the study doctor will be checking the levels of radioactively labeled study medicine in body frequently from Day 7 onwards in urine, stool, and any vomit and will let participants know as soon as possible if they have to stay longer or if they can go home. The duration of participants' stay will depend on how quickly or slowly the radioactively labeled study compound leaves their body.
For Period 2, participants will have to stay in the study clinic for 8 days (7 nights) and leave the study clinic on Day 7. However, if the study doctor believes it is necessary to protect participant's health, they may be asked to remain in the study clinic after Day 7.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered. | 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). | Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14 |
| Metabolite identification/profiling in feces, plasma and urine | Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative recovery (%) of radioactivity in plasma expressed as a percent of total oral radioactive dose administered. | Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14 | |
| Dose normalized AUCinf of intravenous radiolabeled PF-07054894 in plasma (if data permit). |
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Only Male participants aged 18 years to 65 years inclusive (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | Groningen | 9728 NZ | Netherlands |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Parallel Assignment
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Open Label
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| PF-07054894 | Drug | Cohort 2 Period 1 - Oral [Methyl-14C]PF-07054894 under fasted state. |
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Dose normalized area under the plasma concentration-time profile from time zero extrapolated to infinite time following administration of a single intravenous dose of radiolabeled PF-07054894.
| Period 2 Cohort 1 pre-dose to maximum Day 7 |
| The fraction of PF-07054894 dose absorbed (Fa). | Fa calculated from the ratio of total recovered radioactivity [14C] in urine following single dose administration of [14C]PF-07054894 orally in Period 2 Cohort 1 | Period 2 Cohort 1 pre-dose to maximum Day 7 |
| The absolute oral bioavailability (F) of PF-07054894. | The ratio of dose-normalized plasma AUCinf of oral PF-07054894 and IV administration of [14C]PF-07054894 in Period 2 (Cohort 1). | Period 1 of Cohort 1 pre-dose to maximum Day 14 and Period 2 Cohort 1 pre-dose to maximum Day 7 |
| Number of participants with treatment emergent clinically significant laboratory abnormalities | From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2 |
| Number of participants with treatment emergent clinically significant abnormal ECG measurements | From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2 |
| Number of participants with treatment emergent clinically significant abnormal vital measurements | From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2 |
| Maximum Observed Plasma Concentration (Cmax) of PF-07054894 | Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose |
| Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) of PF-07054894 | Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07054894 | Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose |