NCT07127770

A Study to Understand How the Body Processes [14C]PF-07104091 in Healthy Participants

A Phase 1, Open-label, Fixed Sequence, 2-period Study in Healthy Adult Male Participants to Assess the Mass Balance, Absolute Bioavailability, Fraction Absorbed, and Pharmacokinetics of [ 14C]PF-07104091

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Pfizer · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to learn how the body processes the study medicine PF-07104091. The study is seeking participants who are: \- Healthy male aged 18 to 65 years of age Participants in the study will receive 14C-labeled PF-07104091 by mouth after a meal. After 14 days, the participants will receive PF-07104091 by mouth (after a meal) followed by IV fusion (given directly into a vein) of microdose \[14C\]PF-07104091. The study will help understand how the body processes study medicine PF-07104091 and how the medicine is changed and removed from the body after you take it. This study will also help to understand how much PF-07104901 is taken up into the blood. Participants will remain in the study clinic for a maximum of 23 days and will have one follow-up contact.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	PF-07104091	Cyclin-dependent kinase-2 inhibitor

Timeline

• Start date: 2025-08-28
• Primary completion: 2025-10-08
• Completion: 2025-11-07
• First posted: 2025-08-17
• Last updated: 2025-12-19

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study