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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508371-36-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to learn how a certain amount of [14C] PF-06821497 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-06821497 by mouth. Part two will begin at least 14 days after the dose in part one. In part two participants will receive one full dose of PF-06821497 by mouth and one small dose of [14C]PF-06821497 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, and feces will be collected after each dose is given. This will help understand:
Participants will take part in the study for about 11 weeks, including the initial evaluation and follow-up periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive one dose of [14C] PF-06821497 by mouth in Period 1. After a washout, participants will receive one dose of PF-06821497 by mouth and one intravenous (IV) infusion of [14C] PF-06821497 in Period 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral [14C] PF-06821497 | Drug | A single oral dose of [14C] PF-06821497 will be administered as an extemporaneous suspension in Period 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Total recovery of radioactivity in urine, feces, and total excreta (urine + feces) as percentage of total radioactive dose administered | To characterize the extent of excretion of total radioactivity in urine and feces following administration of a single oral dose of [14C]PF-06821497 | Period 1 pre-dose to maximum Day 14 |
| Metabolic profiling/identification and determination of relative abundance of [14C]PF-06821497 and the metabolites of [14C]PF-06821497 in plasma, urine, and feces | Amount of metabolites of [14C]PF-06821497 in plasma, urine, and feces | Period 1 pre-dose to maximum Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute oral bioavailability (F) of [14C]PF-06821497 | To determine the absolute oral bioavailability (F) of PF-06821497 by comparing AUCinf following administration of a single oral dose of PF-06821497 to a single IV microtracer of [14C]PF 06821497 | Period 2 pre-dose to maximum Day 5 |
| Fraction of [14C]PF 06821497 dose absorbed (Fa) |
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Key eligibility criteria for this study include, but are not limited to the following:
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 |
|---|---|---|---|---|---|---|
| PRA Health Sciences | 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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| ID | Term |
|---|---|
| C000710328 | PF06821497 |
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| Oral PF-06821497 | Drug | A single oral dose of PF-06821497 will be administered as an extemporaneous oral suspension in Period 2 |
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| IV [14C] PF-06821497 | Drug | A single IV infusion of [14C] PF-06821497 will be administered at the Tmax after administration of the unlabeled oral dose of PF-06821497 in Period 2 |
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To determine the fraction of the dose absorbed (Fa) following administration of a single oral dose of [14C]PF 06821497 from total urinary radioactivity of [14C]PF 06821497 in Period 1 and IV microtracer microdose administration of [14C]PF 06821497 in Period 2 |
| Period 1 pre-dose to maximum Day 14; Period 2 pre-IV dose to maximum Day 5 |
| AUClast of total radioactivity and PF-06821497 in plasma | To quantify plasma area under the concentration versus time curve (AUClast) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497. | Period 1 pre-dose to maximum Day 14 |
| Cmax of total radioactivity and PF-06821497 in plasma | To quantify plasma peak concentration (Cmax) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497. | Period 1 pre-dose to maximum Day 14 |
| Tmax of total radioactivity and PF-06821497 in plasma | To quantify plasma time of peak concentration (Tmax) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497. | Period 1 pre-dose to maximum Day 14 |
| AUCinf of total radioactivity and PF-06821497 in plasma | If data permits, to quantify plasma area under the concentration versus time curve extrapolated to infinity (AUCinf) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497. | Period 1 pre-dose to maximum Day 14 |
| t½ of total radioactivity and PF-06821497 in plasma | If data permits, to quantify plasma half-life (t½) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497. | Period 1 pre-dose to maximum Day 14 |
| AUClast of [14C]PF-06821497 in plasma | To quantify plasma area under the concentration versus time curve (AUClast) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497. | Period 2 pre-dose to maximum Day 5 |
| Cmax of [14C]PF-06821497 in plasma | To quantify plasma peak concentration (Cmax) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497. | Period 2 pre-dose to maximum Day 5 |
| Tmax of [14C]PF-06821497 in plasma | To quantify plasma time of peak concentration (Tmax) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497. | Period 2 pre-dose to maximum Day 5 |
| t½ of [14C]PF-06821497 in plasma | If data permits, to quantify plasma half-life (t½) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497. | Period 2 pre-dose to maximum Day 5 |
| AUCinf of [14C]PF-06821497 in plasma | If data permits, to quantify plasma area under the concentration versus time curve extrapolated to infinity (AUCinf) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497. | Period 2 pre-dose to maximum Day 5 |
| CL of [14C]PF-06821497 in plasma | If data permits, to quantify plasma clearance (CL) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497. | Period 2 pre-dose to maximum Day 5 |
| Vss of [14C]PF-06821497 in plasma | If data permits, to quantify plasma volume of distribution at steady-state (Vss) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497. | Period 2 pre-dose to maximum Day 5 |
| Number of participants with treatment emergent clinically significant laboratory abnormalities | Both cohorts from pre-dose to 28 days post-dose |
| Number of participants with treatment emergent clinically significant abnormal ECG measurements | Both cohorts from pre-dose to 28 days post-dose |
| Number of participants with treatment emergent clinically significant abnormal vital measurements | Both cohorts from pre-dose to 28 days post-dose |
| Number of participants with treatment emergent clinically significant abnormal physical examination | Both cohorts from pre-dose to 28 days post-dose |
| Number of participants with treatment-emergent adverse events (AEs) or serious adverse events (SAEs) | Both cohorts from pre-dose to 28 days post-dose |