Healthy Adult Participants
Conditions
Brief summary
For this study, the study medicine has been specially prepared to contain radiolabeled carbon \[14C\]. \[14C\] is a naturally occurring radioactive form of the element carbon. Adding a low dose of radiation to the study medicine does not change how the medicine works but helps to see how the medicine appears in the blood, urine, and stool after it is given. This type of study is called a radiolabeled study. The purpose of this radiolabeled study is to learn how a certain amount of \[14C\] PF-07248144 is taken up into the bloodstream and removed from the body. The study is seeking participants who are: * females who cannot have children, or males * 18 years of age or older * confirmed to be healthy based on medical and physical tests. * weigh more than 50 kilograms (kg) and have a body mass index of 18 to 32 kg per meter squared. The study consists of two parts. In part one, all participants will receive one full dose of \[14C\]PF-07248144 by mouth. Part two will begin at least 28 days after the dose in part one. In part two, participants will receive one full dose of PF-07248144 by mouth and one small dose of \[14C\] PF-07248144 by intravenous (IV) infusion. IV infusion will be directly injected into the veins. To understand how the medicine is processed in the body, samples of blood, urine, feces, and vomit (if any) will be collected after each dose is given. This will help understand: * How much PF-07248144 is taken up into the bloodstream when taken by mouth compared to the dose given by IV * How the body removes it from the blood steam. Participants will take part in the study for about 15 weeks, including evaluation at the start and follow-up period.
Interventions
DRUGOral [14C] PF-07248144
A single oral dose of \[14C\] PF-07248144 will be administered as an extemporaneous suspension in Period 1
DRUGOral unlabeled PF-07248144
A single oral dose of unlabeled PF-07248144 will be administered as tablets in Period 2
DRUGIV [14C] PF-07248144
A single IV infusion of \[14C\] PF-07248144 will be administered at the approximate Tmax after administration of the unlabeled oral dose of PF-07248144 in Period 2
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female of nonchildbearing potential or male ≥18 years of age, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead ECGs. * BMI of 18-32 kg/m2; and a total body weight \>50 kg (110 lb).
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing. * Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study. * Total 14C radioactivity measured in plasma should not exceed 2.5 × standard biological carbon ratio.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total recovery of radioactivity in urine, feces and vomitus (if any) expressed as a percent of total radioactive dose administered. | Period 1 pre-dose to maximum Days 22 | To characterize the extent of excretion of total radioactivity in urine, feces, and vomitus (if any) following administration of a single oral dose of \[14C\]PF-07248144. |
| Metabolic profiling/identification and determination of relative abundance of [14C]PF-07248144 and the metabolites of [14C]PF-07248144 in plasma, urine, and feces. | Period 1 pre-dose to maximum Days 22 | To characterize the metabolic profile and identify circulating and excreted metabolites following administration of a single oral dose of \[14C\]PF-07248144. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The ratio of dose-normalized plasma AUCinf (if data permit, otherwise AUClast) of oral unlabeled PF-07248144 and IV microtracer of [14C]PF-07248144 in Period 2 only. | Period 2 pre-dose to maximum Days 10 | To determine the absolute oral bioavailability (F) of PF-07248144 following administration of a single oral dose of PF-07248144 compared to a single IV microtracer of \[14C\]PF-07248144. |
| The ratio of total urinary radioactivity following oral administration of [14C]PF-07248144 in Period 1 and IV microtracer, microdose administration of [14C]PF-07248144 in Period 2. | Period 1 pre-dose to maximum Days 22; Period 2 pre-dose to maximum Days 10 | To determine the fraction of the dose absorbed (Fa) following administration of a single oral dose of \[14C\]PF-07248144. |
| Number of Participants With Treatment Emergent Adverse Events | Baseline and through 28 to 35 days post last study intervention dose | — |
| Number of Participants with Treatment Emergent Clinically Significant Laboratory Abnormalities | From Baseline up to 28 to 35 days post last study intervention dose | — |
| Number of Participants With Treatment Emergent Clinically Significant Abnormal Vital Signs | From Baseline up to 28 to 35 days post last study intervention dose | — |
| Number of Participants With Treatment Emergent Clinically Significant Physical Examination Abnormalities | From Baseline up to 28 to 35 days post last study intervention dose | — |
| Number of Participants With Treatment Emergent Clinically Significant Abnormal ECG Measurements | From Baseline up to 28 to 35 days post last study intervention dose | — |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed