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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
9
Cyclin-dependent kinase-2 inhibitor
ICON
Groningen, Netherlands
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From Predose to 14 days post dose of period 1
Percentage of Metabolite Detected in Urine After Oral Administration of PF-07104091
The percentage of major metabolites detected in urine after oral administration of PF-07104091
Time frame: 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
Time frame: From Predose to 14 days post dose of period 1
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.
Time frame: 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.
Time frame: From Predose up to 14 days post dose
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From baseline up to 35 days after the last dose of study intervention (up to Day 36)
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