At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Oral [14C]PF-07220060, Oral PF-07220060, and 1 other intervention for Healthy Participants. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.