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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:
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:
Participants will take part in the study for about 15 weeks, including evaluation at the start and follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive one dose of [14C] PF-07248144 by mouth in Period 1. After a washout, participants will receive one dose of PF-07248144 by mouth and one intravenous (IV) infusion of [14C] PF-07248144 in Period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral [14C] PF-07248144 | Drug | A single oral dose of [14C] PF-07248144 will be administered as an extemporaneous suspension in Period 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total recovery of radioactivity in urine, feces and vomitus (if any) expressed as a percent of total radioactive dose administered. | 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. | Period 1 pre-dose to maximum Days 22 |
| Metabolic profiling/identification and determination of relative abundance of [14C]PF-07248144 and the metabolites of [14C]PF-07248144 in plasma, urine, and feces. | To characterize the metabolic profile and identify circulating and excreted metabolites following administration of a single oral dose of [14C]PF-07248144. | Period 1 pre-dose to maximum Days 22 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Period 2 pre-dose to maximum Days 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit - Madison | Madison | Wisconsin | 53704 | United States | ||
| Fortrea Clinical Research Unit Inc. |
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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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| Oral unlabeled PF-07248144 | Drug | A single oral dose of unlabeled PF-07248144 will be administered as tablets in Period 2 |
|
| IV [14C] PF-07248144 | Drug | 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 |
|
| 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. | To determine the fraction of the dose absorbed (Fa) following administration of a single oral dose of [14C]PF-07248144. | Period 1 pre-dose to maximum Days 22; Period 2 pre-dose to maximum Days 10 |
| 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 |
| Madison |
| Wisconsin |
| 53704 |
| United States |