A Phase 1 interventional study of Oral [14C]PF-07220060 and Oral PF-07220060 in Healthy Participants, sponsored by Pfizer. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants.
The study is seeking for participants who:
The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.
In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.
During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up.
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-07220060 by mouth
Drug: Oral [14C]PF-07220060
Participants will take one dose of PF-07220060 by mouth and one dose as an IV (intravenous) infusion of \[14C\] PF-07220060.
Drug: Oral PF-07220060 · Drug: IV [14C] PF-07220060
A single oral dose of \[14C\]PF-07220060, will be administered as a liquid formulation in Cohort 1.
A single oral dose of PF-07220060, will be administered as a liquid formulation in Cohort 2.
A single IV infusion of \[14C\]PF-07220060 will be administered in Cohort 2 at Tmax after the administration of the unlabeled oral dose.
Percentage of Total Radiocarbon (14C) Excreted in Urine
Percentage of 14C excreted in urine following 14C PF-07220060 dose administration was determined as: (total 14C urine/ 14C dose administered)\*100 where, 14C dose was administered dose of 14C PF-07220060.
Time frame: From Predose up to 14 days post-dose
Percentage of Total Radiocarbon (14C) Excreted in Feces: Cohort 1
Percentage of 14C excreted in feces following 14C PF-07220060 oral dose administration was determined as: (total 14C feces/ 14C oral dose administered)\*100 where, 14C dose was administered dose of 14C PF-07220060.
Time frame: From Predose up to 14 days post-dose
Cumulative Percent Recovery of Total Radiocarbon (14C)
Percentage recovery of total radioactivity (14C ) in urine and feces was determined based on total administered dose.
Time frame: From Predose up to 14 days post-dose
Percentage of Metabolite Detected in Plasma After Oral Administration of PF-07220060: Cohort 1
The percentage of five major metabolites detected in plasma after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by liquid chromatography mass spectrometry- accelerator mass spectrometry (LC-MS-AMS). For calculation of metabolite percentage of total plasma radioactivity (RA), first composite time-normalized human plasma pools were prepared for each participant from plasma samples collected from 0-96 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
Time frame: From Predose up to 96 hours post-dose
Percentage of Metabolite Detected in Urine After Oral Administration of PF-07220060: Cohort 1
The percentage of five major metabolites detected in urine after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human urine pools were prepared for each participant from urine samples collected from 0-144 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
Time frame: From Predose up to 144 hours post-dose
Percentage of Metabolite Detected in Feces After Oral Administration of PF-07220060: Cohort 1
The percentage of five major metabolites detected in feces after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human fecal homogenate pools were prepared for each participant from fecal samples collected from 0-196 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
Time frame: From Predose up to 196 hours post-dose
Percentage of Metabolite Detected in Feces After IV Administration of PF-07220060: Cohort 2
The percentage of five major metabolites detected in feces after IV administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human fecal homogenate pools were prepared for each participant from fecal samples collected from 0-196 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
Time frame: From Predose up to 196 hours post-dose
Absolute Oral Bioavailability for Plasma Dose-Normalized Area Under the Curve (AUC)Infinity: Cohort 2
Dose normalized AUCinf (AUCinf\[dn\]) was calculated as AUCinf/Dose, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Absolute oral bioavailability was defined as the ratio of geometric mean of AUCinf(dn) following orally administered PF-07220060 (i.e., unlabeled PF-07220060) to AUCinf(dn) following intravenously administered \[14C\]PF-07220060 and reported in the statistical analysis section.
Time frame: From Predose up to 14 days post-dose
Cohort 1 and 2: Fraction of PF-07220060 Dose Absorbed (Fa)
Fraction of dose absorbed (Fa) was estimated as the ratio of total 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-07220060 microtracer doses in cohort 1 and 2, respectively. The total radioactivity excreted in urine following oral and IV administration, expressed as percentage of radioactive dose administered is reported in the descriptive section and fraction of dose absorbed is reported in the statistical analysis section.
Time frame: From Predose up to 14 days post-dose
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were defined as any AEs that occurred following start of study intervention and during follow-up within the lag time of up to 35 days after the last dose of study intervention.
Time frame: Baseline up to 35 days after the last dose of study intervention (up to Day 36)
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Following laboratory parameters were analyzed: clinical chemistry: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonates, total bilirubin, calcium, chloride, creatinine, cystatin C, estimated glomerular filtration rate (eGFR) serum creatinine, glucose, potassium, protein, sodium, uric acid, blood urea nitrogen. Hematology included basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets and reticulocyte count. Urinalysis included: glucose, blood, ketones, leukocytes esterase, nitrite, protein and pH. Clinical significance of laboratory abnormalities was determined by investigator.
Time frame: 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
Vital signs included blood pressure and pulse rate. Blood pressure was measured with the participant in a supine position using an automated device after at least 5 minutes rest for the participant. Clinical significance of vital signs was determined based on investigator's discretion.
Time frame: 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
Standard 12-lead ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QT and, corrected QT interval using Fridericia's formula (QTcF) and QRS interval. Clinical significance of ECG abnormalities was determined based on investigator's discretion.
Time frame: Baseline up to 35 days after the last dose of study intervention (up to Day 36)
| Milestone | Cohort 1: 14C PF-07220060 100 mg Oral | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
Percentage of 14C excreted in urine following 14C PF-07220060 dose administration was determined as: (total 14C urine/ 14C dose administered)\*100 where, 14C dose was administered dose of 14C PF-07220060.
| Percentage of 14C in urine | Cohort 1: 14C PF-07220060 100 mg Oral | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV |
|---|---|---|
| Percentage of Total Radiocarbon (14C) Excreted in Urine | 11.9 ± 3.0 | 20.7 ± 3.0 |
Percentage of 14C excreted in feces following 14C PF-07220060 oral dose administration was determined as: (total 14C feces/ 14C oral dose administered)\*100 where, 14C dose was administered dose of 14C PF-07220060.
| Percentage of 14C in feces | Cohort 1: 14C PF-07220060 100 mg Oral |
|---|---|
| Percentage of Total Radiocarbon (14C) Excreted in Feces: Cohort 1 | 75.4 ± 10.2 |
Percentage recovery of total radioactivity (14C ) in urine and feces was determined based on total administered dose.
| Percentage of 14C in urine and feces | Cohort 1: 14C PF-07220060 100 mg Oral | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV |
|---|---|---|
| Cumulative Percent Recovery of Total Radiocarbon (14C) | 87.4 ± 9.8 | 88.8 ± 3.4 |
The percentage of five major metabolites detected in plasma after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by liquid chromatography mass spectrometry- accelerator mass spectrometry (LC-MS-AMS). For calculation of metabolite percentage of total plasma radioactivity (RA), first composite time-normalized human plasma pools were prepared for each participant from plasma samples collected from 0-96 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
| Metabolite percentage of total plasma RA | Cohort 1: 14C PF-07220060 100 mg Oral |
|---|---|
| 480a | 1.1 |
| 480b | 2.3 |
| 496a | 0.53 |
| M3 | 0.81 |
| 496b | 1.6 |
The percentage of five major metabolites detected in urine after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human urine pools were prepared for each participant from urine samples collected from 0-144 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
| Recovered metabolite as % of RA given | Cohort 1: 14C PF-07220060 100 mg Oral |
|---|---|
| 480a | 0.32 |
| 480b | 0.61 |
| 496a | 0.32 |
| M3 | 0.22 |
| 496b | 1.2 |
The percentage of five major metabolites detected in feces after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human fecal homogenate pools were prepared for each participant from fecal samples collected from 0-196 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
| Recovered metabolite as % of RA given | Cohort 1: 14C PF-07220060 100 mg Oral |
|---|---|
| 480a | 1.3 |
| 480b | 9.4 |
| 496a | 5.9 |
| M3 | 1.7 |
| 496b | 10 |
The percentage of five major metabolites detected in feces after IV administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human fecal homogenate pools were prepared for each participant from fecal samples collected from 0-196 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
| Recovered metabolite as % of RA given | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV |
|---|---|
| 480a | 3.6 |
| 480b | 11 |
| 496a | 7.3 |
| M3 | 1.9 |
| 496b | 13 |
Dose normalized AUCinf (AUCinf\[dn\]) was calculated as AUCinf/Dose, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Absolute oral bioavailability was defined as the ratio of geometric mean of AUCinf(dn) following orally administered PF-07220060 (i.e., unlabeled PF-07220060) to AUCinf(dn) following intravenously administered \[14C\]PF-07220060 and reported in the statistical analysis section.
| Nanogram*hour/ milliliter/ milligram | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV |
|---|---|
| AUCinf(dn) following oral dose | 18.29 ± 37 |
| AUCinf(dn) following IV dose | 52.18 ± 29 |
Fraction of dose absorbed (Fa) was estimated as the ratio of total 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-07220060 microtracer doses in cohort 1 and 2, respectively. The total radioactivity excreted in urine following oral and IV administration, expressed as percentage of radioactive dose administered is reported in the descriptive section and fraction of dose absorbed is reported in the statistical analysis section.
| Percentage of radioactive dose | Cohort 1: 14C PF-07220060 100 mg Oral | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV |
|---|---|---|
| Cohort 1 and 2: Fraction of PF-07220060 Dose Absorbed (Fa) | 11.62 ± 24 | 20.54 ± 14 |
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were defined as any AEs that occurred following start of study intervention and during follow-up within the lag time of up to 35 days after the last dose of study intervention.
| Participants | Cohort 1: 14C PF-07220060 100 mg Oral | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 4 (24 to —) | 4 (14 to —) |
Following laboratory parameters were analyzed: clinical chemistry: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonates, total bilirubin, calcium, chloride, creatinine, cystatin C, estimated glomerular filtration rate (eGFR) serum creatinine, glucose, potassium, protein, sodium, uric acid, blood urea nitrogen. Hematology included basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets and reticulocyte count. Urinalysis included: glucose, blood, ketones, leukocytes esterase, nitrite, protein and pH. Clinical significance of laboratory abnormalities was determined by investigator.
| Participants | Cohort 1: 14C PF-07220060 100 mg Oral | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV |
|---|---|---|
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | 0 (24 to —) | 0 (14 to —) |
Vital signs included blood pressure and pulse rate. Blood pressure was measured with the participant in a supine position using an automated device after at least 5 minutes rest for the participant. Clinical significance of vital signs was determined based on investigator's discretion.
| Participants | Cohort 1: 14C PF-07220060 100 mg Oral | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV |
|---|---|---|
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | 0 (24 to —) | 0 (14 to —) |
Standard 12-lead ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QT and, corrected QT interval using Fridericia's formula (QTcF) and QRS interval. Clinical significance of ECG abnormalities was determined based on investigator's discretion.
| Participants | Cohort 1: 14C PF-07220060 100 mg Oral | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV |
|---|---|---|
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | 0 (24 to —) | 0 (14 to —) |
Collected over Baseline up to 35 days after the last dose of study intervention (up to Day 36). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: 14C PF-07220060 100 mg Oral | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Event | Cohort 1: 14C PF-07220060 100 mg Oral | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV |
|---|---|---|
| HeadacheNervous system disorders | 1/6 | 2/6 |
| Abdominal painGastrointestinal disorders | 0/6 | 1/6 |
| DyspepsiaGastrointestinal disorders | 1/6 | 0/6 |
| Application site irritationGeneral disorders | 0/6 | 1/6 |
| Influenza like illnessGeneral disorders | 1/6 | 0/6 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/6 | 1/6 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/6 | 1/6 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 1/6 | 0/6 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/6 | 0/6 |
| Dry skinSkin and subcutaneous tissue disorders | 1/6 | 0/6 |
Safety Analysis set comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Age, Continuous(Years) | Cohort 1: 14C PF-07220060 100 mg Oral | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV | Total |
|---|---|---|---|
| Mean | 44.5 ± 20.10 | 40.3 ± 11.06 | 42.4 ± 15.62 |
| Sex: Female, Male(Participants) | Cohort 1: 14C PF-07220060 100 mg Oral | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 6 | 6 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1: 14C PF-07220060 100 mg Oral | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 6 | 6 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1: 14C PF-07220060 100 mg Oral | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 5 | 6 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
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.
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