NCT07130097

A Study to Compare Two Tablet Formulations of Study Medicine Atirmociclib in Healthy Participants

A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER, PIVOTAL BIOEQUIVALENCE STUDY TO COMPARE ATIRMOCICLIB (PF-07220060) HIGHER DRUG LOAD IR MST TABLETS AND ATIRMOCICLIB IR MST TABLETS ADMINISTERED UNDER FED CONDITIONS IN HEALTHY ADULT PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to understand bioequivalence (medicines that may have different names or be made in different ways, but have the same effect on the body) of the current PF-07220060 tablet formulation and the proposed higher drug load tablet that is already available in the market. The study is seeking participants who are: * Healthy males and females aged 18 to 65 years * Willing and able to comply with all scheduled visits, treatment plan, lifestyle considerations, and other study procedures. * Body Mass Index of 17.5-30.5 kilogram per meter squared (kg/m2); and a total body weight of more than 50 kilograms (kg) \[110 pounds (lb)\]. Participants in the study will receive a single dose of PF-07220060 by mouth after a meal, following at least 7 days, the participant will then receive another dose of PF-07220060. Each dose received by the participant will be a different tablet formulation, and the sequence of tablet formulations given will be random (just like a flipside of the coin). The study will help the team understand how the difference in tablet formulation may, or may not, affect how the medicine is absorbed, processed, and removed by the body. Participants will remain in the study clinic for at least 13 days and will have one follow-up contact.

Conditions

• Healthy Participant

Interventions

Type	Name	Description
DRUG	PF-07220060	Cyclin-dependent kinase-4 inhibitor

Timeline

• Start date: 2025-08-14
• Primary completion: 2025-10-26
• Completion: 2025-11-18
• First posted: 2025-08-19
• Last updated: 2025-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study