Phase 1
N=12
A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults
Healthy Participants
Bottom Line
View on ClinicalTrials.gov: NCT06267963 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Percentage of Total Radiocarbon (14C) Excreted in Urine — 11.9; 20.7 Percentage of 14C in urine
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Oral [14C]PF-07220060 (Drug); Oral PF-07220060 (Drug); IV [14C] PF-07220060 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Pfizer
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Total Radiocarbon (14C) Excreted in Urine |
11.9; 20.7 | — |
| PRIMARY Percentage of Total Radiocarbon (14C) Excreted in Feces: Cohort 1 |
75.4 | — |
| PRIMARY Cumulative Percent Recovery of Total Radiocarbon (14C) |
87.4; 88.8 | — |
| PRIMARY Percentage of Metabolite Detected in Plasma After Oral Administration of PF-07220060: Cohort 1 |
1.1; 2.3; 0.53; 0.81; 1.6 | — |
| PRIMARY Percentage of Metabolite Detected in Urine After Oral Administration of PF-07220060: Cohort 1 |
0.32; 0.61; 0.32; 0.22; 1.2 | — |
| PRIMARY Percentage of Metabolite Detected in Feces After Oral Administration of PF-07220060: Cohort 1 |
1.3; 9.4; 5.9; 1.7; 10 | — |
| PRIMARY Percentage of Metabolite Detected in Feces After IV Administration of PF-07220060: Cohort 2 |
3.6; 11; 7.3; 1.9; 13 | — |
| SECONDARY Absolute Oral Bioavailability for Plasma Dose-Normalized Area Under the Curve (AUC)Infinity: Cohort 2 |
18.29; 52.18 | — |
| SECONDARY Cohort 1 and 2: Fraction of PF-07220060 Dose Absorbed (Fa) |
11.62; 20.54 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
4; 4 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Vital Signs |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities |
0; 0 | — |
Summary
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:
* are males aged 18 to 65 years and are healthy.
* have Body mass index (BMI) between 17.5 and 30.5 kilograms/meter2
* have a total body weight of at least 50 kilograms.
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.
Eligibility Criteria
Key Eligibility criteria for this study include, but are not limited to the following:
Inclusion Criteria
- Male participants aged 18 to 65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body mass index (BMI) of 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Exclusion Criteria
- Participants with a history of irregular bowel movements (eg, regular episodes of diarrhea or constipation, irritable bowel syndrome [IBS] or lactose intolerance).
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of study intervention used in this study. Previous exposure to PF-07220060 or participation in studies requiring PF-07220060 administration.
- Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.
Data sourced from ClinicalTrials.gov (NCT06267963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.