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Trials / Completed

CompletedNCT06267963

A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults

A PHASE 1, OPEN-LABEL, PARALLEL-GROUP, SINGLE-DOSE STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C]-PF-07220060 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07220060 USING A 14C-MICROTRACER APPROACH

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
12 (actual)
Sponsor
Pfizer · Industry
Sex
Male
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGOral [14C]PF-07220060A single oral dose of \[14C\]PF-07220060, will be administered as a liquid formulation in Cohort 1.
DRUGOral PF-07220060A single oral dose of PF-07220060, will be administered as a liquid formulation in Cohort 2.
DRUGIV [14C] PF-07220060A single IV infusion of \[14C\]PF-07220060 will be administered in Cohort 2 at Tmax after the administration of the unlabeled oral dose.

Timeline

Start date
2024-01-31
Primary completion
2024-04-12
Completion
2024-04-12
First posted
2024-02-20
Last updated
2026-03-10
Results posted
2026-03-10

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT06267963. Inclusion in this directory is not an endorsement.