Healthy Adults
Conditions
Keywords
Pharmacokinetics, Healthy Volunteers, Biological Availability, Absorption, Elimination, Distribution, ADME, Bioavailability, Radiolabeled, Metabolic Profile, Renal Elimination, Mass Balance, Small molecule, Absolute Bioavailability
Brief summary
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.
Interventions
DRUGPF-07104091
Cyclin-dependent kinase-2 inhibitor
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12-lead ECGs. * Body mass index (BMI) of 17.5-32.0 kg/m2 inclusive and a total body weight \>50 kg (110 lb) * Evidence of a personally signed and dated Informed Consent Document (ICD) indicating that the participant has been informed of all pertinent aspects of the study. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Metabolite Detected in Feces After Oral Administration of PF-07104091 | From Predose to 14 days post dose of period 1 | The percentage of major metabolites detected in feces after oral administration of PF-07104091 |
| Percentage of Total Radiocarbon (14c) excreted in urine | From Predose up to 14 days post dose of period 1 and 2 | 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. |
| Percentage of Total Radiocarbon (14c) excreted in feces | From Predose up to 14 days post dose of period 1 (and if applicable for Period 2) | 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. |
| Percentage of Total Radiocarbon (14c) excreted in vomitus (if applicable) | From Predose up to 14 days post dose of period 1 only | 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. |
| Cumulative Percent Recovery of Total Radiocarbon (14C) | From Predose up to 14 days post dose of period 1 only | Percentage recovery of total radioactivity (14C) in urine, feces, and vomitus (If applicable) was determined based on total administered dose. |
| Percentage of Metabolite Detected in Plasma After Oral Administration of PF-07104091 | From Predose to 14 days post dose of period 1 | The percentage of major metabolites detected in plasma after oral administration of PF-07104091 |
| Percentage of Metabolite Detected in Urine After Oral Administration of PF-07104091 | From Predose to 14 days post dose of period 1 | The percentage of major metabolites detected in urine after oral administration of PF-07104091 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fraction of PF-07104091 Dose Absorbed (Fa) | From Predose up to 14 days post dose | 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. |
| 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) | — |
| Oral Absolute Bioavailability | From Predose up to 14 days post dose, period 2 only. | 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. |
Countries
Netherlands
Outcome results
None listed