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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518696-65-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to learn how the body processes the study medicine PF-07104091.
The study is seeking participants who are:
- Healthy male aged 18 to 65 years of age
Participants in the study will receive 14C-labeled PF-07104091 by mouth after a meal. After 14 days, the participants will receive PF-07104091 by mouth (after a meal) followed by IV fusion (given directly into a vein) of microdose [14C]PF-07104091.
The study will help understand how the body processes study medicine PF-07104091 and how the medicine is changed and removed from the body after you take it. This study will also help to understand how much PF-07104901 is taken up into the blood.
Participants will remain in the study clinic for a maximum of 23 days and will have one follow-up contact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A; Period 1 | Experimental | Single oral dose of 14C-labeled PF-07104091 administered under fed conditions. |
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| Regimen B; Period 2 | Experimental | Single oral dose of unlabeled PF-07104091 administered under fed conditions followed by an intravenous (IV) infusion of PF-07104091 containing a microdose of 14C-labeled PF-07104091. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07104091 | Drug | Cyclin-dependent kinase-2 inhibitor |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Total Radiocarbon (14c) excreted in urine | Percentage of 14C excreted in urine following 14C PF-07104091 single dose administration will be determined as: (Total 14C urine/ 14C dose administered) *100 where, 14C dose was administered dose of 14C PF-07104091. | From Predose up to 14 days post dose of period 1 and 2 |
| Percentage of Total Radiocarbon (14c) excreted in feces | Percentage of 14C excreted in feces following 14C PF-07104091 single dose administration will be determined as: (Total 14C feces/ 14C dose administered) *100 where, 14C dose was administered dose of 14C PF-07104091. | From Predose up to 14 days post dose of period 1 (and if applicable for Period 2) |
| Percentage of Total Radiocarbon (14c) excreted in vomitus (if applicable) | Percentage of 14C excreted in vomitus (if applicable) following 14C PF-07104091 single dose administration will be determined as: (Total 14C vomitus/ 14C dose administered) *100 where, 14C dose was administered dose of 14C PF-07104091. | From Predose up to 14 days post dose of period 1 only |
| Cumulative Percent Recovery of Total Radiocarbon (14C) | Percentage recovery of total radioactivity (14C) in urine, feces, and vomitus (If applicable) was determined based on total administered dose. | From Predose up to 14 days post dose of period 1 only |
| Percentage of Metabolite Detected in Plasma After Oral Administration of PF-07104091 | The percentage of major metabolites detected in plasma after oral administration of PF-07104091 | From Predose to 14 days post dose of period 1 |
| Percentage of Metabolite Detected in Urine After Oral Administration of PF-07104091 |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Absolute Bioavailability | Dose normalized AUCinf (AUCinf[dn]) will be calculated as AUCinf/Dose, where AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Absolute oral bioavailability is defined as the ratio of geometric mean of AUCinf(dn) following orally administered PF-07104091 (i.e., unlabeled PF-07104091) to AUCinf(dn) following intravenously administered [14C]PF-07104091 in period 2. |
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Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12-lead ECGs
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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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The percentage of major metabolites detected in urine after oral administration of PF-07104091 |
| From Predose to 14 days post dose of period 1 |
| Percentage of Metabolite Detected in Feces After Oral Administration of PF-07104091 | The percentage of major metabolites detected in feces after oral administration of PF-07104091 | From Predose to 14 days post dose of period 1 |
| From Predose up to 14 days post dose, period 2 only. |
| Fraction of PF-07104091 Dose Absorbed (Fa) | Fraction of dose absorbed (Fa) will be estimated as the ratio of total or partial radioactivity (dose normalized) excreted into the urine (from time 0 to the time of last measurable concentration) following oral and IV administration of [14C]PF-07104091 microtracer dose in Period 1 and 2, respectively. | From Predose up to 14 days post dose |
| Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters | From baseline up to 35 days after the last dose of study intervention (up to Day 36) |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From baseline up to 35 days after the last dose of study intervention (up to Day 36) |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | From baseline up to 35 days after the last dose of study intervention (up to Day 36) |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | From baseline up to 35 days after the last dose of study intervention (up to Day 36) |