A Phase 1 interventional study of Oral [14C] PF-06821497 and Oral PF-06821497 in Healthy Participants, sponsored by Pfizer. Completed at 1 site in Netherlands. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key eligibility criteria for this study include, but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
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
Drug: Oral [14C] PF-06821497 · Drug: Oral PF-06821497 · Drug: IV [14C] PF-06821497
A single oral dose of \[14C\] PF-06821497 will be administered as an extemporaneous suspension in Period 1
A single oral dose of PF-06821497 will be administered as an extemporaneous oral suspension in Period 2
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
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
Time frame: 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
Time frame: Period 1 pre-dose to maximum Day 14
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
Time frame: Period 2 pre-dose to maximum Day 5
Fraction of [14C]PF 06821497 dose absorbed (Fa)
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Period 2 pre-dose to maximum Day 5
Number of participants with treatment emergent clinically significant laboratory abnormalities
Time frame: Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment emergent clinically significant abnormal ECG measurements
Time frame: Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment emergent clinically significant abnormal vital measurements
Time frame: Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment emergent clinically significant abnormal physical examination
Time frame: Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment-emergent adverse events (AEs) or serious adverse events (SAEs)
Time frame: Both cohorts from pre-dose to 28 days post-dose
Plan to share: No — 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.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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